 Patent Application Title |
Patent App Num. |
Date |
| Neurostimulator system, apparatus, and method | 20130116745 | 20130509 |
 The invention relates to a method (200) for conducting a clinical trial with a medical device. The method (200) includes the step (202) of providing a medical device to a trial subject, the medical device being capable of providing an adjustable level of therapy. The method also comprises the step (204) of using the medical device to apply therapy to the trial subject. The method further comprises the step (206) of controlling the application of therapy applied to the trial subject according to a clinical trial design.
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| Qualifying raters for clinical trials | 20130085770 | 20130404 |
 The invention provides an efficient approach to qualifying raters to serve in a clinical trial or study, where efficiency includes all aspects pertinent to study raters: creating of qualification profile; identification of appropriate study sites and raters, selection, training, and supplemental qualification of raters during the course of a clinical study or trial, as may be necessitated by study protocol changes or other changes that may occur.
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| Method, system, and apparatus for clinical trial management over a communications network | 20130080186 | 20130328 |
 A centralized, online clinical study system configured to coordinate aspects of a clinical study can include a training module configured to evaluate whether users have completed training for selected workflows for the clinical study that are available from the clinical study system, and to provide training to registered users for the selected workflows. The system also can include a financial engine configured to determine when a participating site meets or exceeds a milestone of the clinical study and to initiate a payment to the participating site. Further, the system can include a module configured to receive and verify clinical research data and to designate the verified clinical research data as official source data for the clinical study.
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| Biomarker to measure drug efficacy in enteropathic disease | 20130065255 | 20130314 |
 The diagnosis of a patient with an enteropathic disease or the response of a patient with an enteropathic disease to therapy, particularly a candidate therapy in a clinical trial setting, is assessed by detecting the ability of the patient to metabolize an orally administered CYP3A substrate. The CYP3A metabolism may be monitored in a variety of ways. Conveniently, the appearance of a metabolite of the CYP3A substrate is detected in a patient sample over a period of time following oral administration, e.g. in urine, plasma, serum breath, saliva, etc. The CYP3A substrate is optionally labeled, e.g. with an isotopic, fluorescent, etc. label.
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| Computer system and method for training, certifying or monitoring human clinical raters | 20130059282 | 20130307 |
 A method and system are disclosed for computerized training, monitoring, certification or re-certification of human raters in clinical trials. The invention provides an interactive computerized interview that can be compared scores obtained by human raters to monitor and train clinical raters on a continuing basis in order to reduce rater drift and variance during clinical trials. Remediation can be automatically flagged or provided to improve a deviating rater's performance. Computerized assessment of symptom severity is provided without the need for human clinical raters. The system and method enable screening of prospective patients for inclusion or exclusion from a clinical trial by automatically obtaining computerized ratings of symptom severity.
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| Method and system for presenting composite risk assessment data and clinical trial data for pharmaceutical drugs | 20130060771 | 20130307 |
| A risk metrics information platform implemented as a reimbursement risk tracker application facilitates gathering, synthesizing, and presenting risk related data to users to foster a better understanding of pricing and reimbursement market risk for pipeline compounds and marketed pharmaceutical products. In one embodiment, the reimbursement risk tracker application provides a visually intuitive dashboard to help demonstrate how different global agencies look at a drug class or a therapeutic area. In another embodiment, a clinical trial tracker similarly facilitates gathering, synthesizing, and presenting of data relating to studies and outcomes across a number of different markets to foster a better understanding of the evaluation criteria as well as the conclusions of clinical trial studies.
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| System and method for performing pharmacovigilance | 20130013332 | 20130110 |
| A method and system for tracking patient's response during a clinical trial of a drug, includes publishing an informational item about the clinical trial at a social media platform or a file sharing website; inducing patients to post trial related response at the social media platform or to obtain the informational item from the file sharing website; aggregating patients' responses from the social media platform, download information of the informational item published on the file sharing website, or search queries from search engines; and analyzing aggregated patients' responses, download information, or search queries to obtain knowledge related to the clinical trial.
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| Systems and methods for automated informed consent | 20120310670 | 20121206 |
| An automated, personalized informed consent creation and verification process is provided herein. Multimedia, interactive informed consent presentations may be created for medical procedures or clinical trials which are procedure-specific or trial-specific by providing standardized disclosure information to a patient regarding a specific medical procedure or clinical trial which is being performed. The presentation is also patient specific by using the patient's medical history to personalize the disclosures regarding risk and expected outcome of the procedure. The presentation may be provided on a computer, such as a tablet, where the patient views and interacts with the informed consent presentation to ask and answer questions, indicate their capacity to make a decision and verify comprehension of the content of the presentation. The patient's consent may be recorded in... |
| Method and apparatus for verification of clinical trial adherence | 20120310671 | 20121206 |
| A system and method of confirming administration of medication in a clinical trial is provided. The method comprises the steps of receiving information identifying a particular medication prescription regimen in accordance with the clinical trial, determining one or more procedures for administering such prescription regimen and identifying one or more activity sequences associated with such procedures. Activity sequences of actual administration of such prescription regimen are captured and then compared to the identified activity sequences to determine differences therebetween. A notice is provided if differences are determined.
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| Method for organizing clinical trial data | 20120296664 | 20121122 |
| A method for creating multiple tagged clinical trial data and a tool therefrom is disclosed. The method comprises receiving clinical trial information from different sources, and removing redundancies from the clinical trial information received from the plurality of sources to form collated clinical trial data. The method further involves baseline tagging of the collated clinical data using non-indication parameters, creating a disease specific list of indication parameters, where indication parameters are classified into at least main indication parameters and sub indication parameters. The method further includes advanced tagging of the collated clinical trial data using indication parameters and creating multiple tagged clinical data using baseline tagging and advanced tagging.
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| Tool for clinical data mining and analysis | 20120290317 | 20121115 |
| In one aspect, the invention provides a clinical trial information management tool. The tool comprises an interface with a multiple tagged clinical trial database; a user interface for receiving user inputs, a search engine to query the multiple tagged clinical trial database in one or more levels based on user inputs; a display platform to display results from the query in one or more views; an analytics engine to provide at least one of parameter based analysis and graphical analysis; and a personalization platform to store the query and the results. The tool provides the advantage through the rapid, facile and user-friendly manner in which clinical trial information from a wide variety of sources may be searched, analyzed and reported by a user, which allows for... |
| Biomarkers predictive of progression of fibrosis | 20120282276 | 20121108 |
| The present invention provides methods and kits for prognosing the progression of fibrosis in a subject having fibrosis, as well as methods for identifying a compound that can slow down the progression of fibrosis in a subject having fibrosis, methods of monitoring the effectiveness of a therapy in reducing the progression of fibrosis in a subject having fibrosis, methods of selecting a subject for participation in a clinical trial for the treatment of fibrosis, and methods for inhibiting progression of fibrosis in a cell or a subject having fibrosis. The methods are based on determining the level of Toll-like recepter 9 (TLR9).
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| Method and apparatus for administering clinical trials | 20120259647 | 20121011 |
| A system and method for administering a clinical trial centralizes all trial communications in a website system. The system enables a trial sponsor to create individual websites for each of its available trials using website templates driven by workflow management software. The prospective clinical investigator can browse current and upcoming clinical trials and select trials that he/she wants to participate in. The clinical investigator can register interest in the trial by entering their contact information and professional credentials to create a personal profile. The trial sponsor can search for prospective clinical investigators whose credentials are commensurate with those required for a clinical trial. The trial sponsor also can invite prospective clinical investigators to participate in clinical trials. The system programmatically creates a secure account the clinical... |
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| System for clinical trial subject compliance | 20120239414 | 20120920 |
| The present invention is designed to develop research protocols for clinical trials. The invention also can track and enhance subject compliance with a research protocol. The invention further provides evaluability data related to subject performance in the clinical trial. According to an alternative embodiment of the invention, a portable electronic device is used to query and collect data from the subject.
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| System and method for ensuring integrity of clinical trial results | 20120232921 | 20120913 |
| The system and method utilize the inter-relationship of items in a psychological instrument or instruments and have been demonstrated empirically to detect problematic conceptualizations of constructs. Scores from the instruments are submitted for review. The scores are analyzed by a computer program that compares item level scores with expected values based on the item inter-relationships. If inconsistencies are discovered a flag is generated. If inconsistencies are deemed actionable then remedial action or contact is scheduled with the site-based clinician or “rater” who conducted the patient assessment using the instrument or instruments. The site-based clinician is contacted and an information exchange about the case occurs in which the site-based clinician provides an overview of symptom presentation. This symptom presentation is then matched to the item level scores... |
| Tracking and using clinical trial protocol feasibility information | 20120232949 | 20120913 |
| Systems and methods are disclosed for managing information from a feasibility study of a clinical trial protocol. Data relationships in a database can be utilized to, for example, formulate bids for managing a clinical trial protocol, track information about a feasibility study, output reminder notifications regarding overdue documents in connection with the feasibility study, provide information for use in site start-up or other processes implemented in conducting the clinical trial protocol, and allow feasibility study information to be analyzed after a clinical trial protocol has been conducted.
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| System and methods for quantitative image analysis platform over the internet for clinical trials | 20120207361 | 20120816 |
| The present disclosure is directed at a system and method for analyzing clinical trial data over a network. The system and method specifics image protocols, encodes a number of protocols and communicates that information to an acquisition unit that appends the protocols to a digital image. When the image needs to be analyzed to gather clinical trial data, the encoded information is extracted and the correct software application is initialized and used to analyze the image.
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| System for matching individuals with health care providers and methods thereof | 20120209628 | 20120816 |
| A system for matching individuals with health care providers and methods thereof. The system is capable of collecting information from health care providers and individuals and thereafter matching individuals with clinical trial providers based upon that information by utilizing coding to eliminate medical terminology ambiguity. The system continually updates the degree of likelihood of a match of a health care provider with an individual based upon individual feedback and clinical trial provider feedback relating to results achieved from treatment provided by a given health care provider. The system also notifies individuals of experimental clinical trials that can be potentially applicable to the individual based upon the information provided by the individual.
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| System and method for evaluating and comparing medical treatments | 20120185266 | 20120719 |
| An evaluative software tool to support the assessment of health care-related technologies during development to facilitate making critical decisions for an optimized research, development and commercialization plan is provided. The software tool includes the ability to measure, weight, and integrate the critical factors that come into play in the development of a risk/benefit profile of a technology relative to its competitors, benchmarked around clinical trial measures, in order to determine its development and commercialization success.
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| Medication compliance monitor - method and apparatus | 20120165975 | 20120628 |
| A remote monitoring of the daily dispensing of prescription drugs by at-home care, an elderly or clinical trial patient is proposed. The system consists of a dispensing unit equipped with weight sensing mechanism such as scale or balance which communicates with the monitoring application residing in the wireless terminal, such as cellular phone over the Personal Area Network (PAN) wireless interfaces such as Bluetooth. The monitoring application provides supervision over the medication dispensing process as well as communication with unauthorized medical supervisor using wireless Wide Area Network (WAN) connection to the Internet.
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| Determining clinical trial candidates from automatically collected non-personally identifiable demographics | 20120166209 | 20120628 |
| Non-personally identifiable demographics associated with a patient during a communication session can be collected. The patient can be associated with one or more healthcare providers which can be associated with a one or more healthcare professionals. The demographics can be compared against a clinical trial profile associated with a clinical trial. The clinical trial profile can specify one or more target group parameters associated with a target group of the clinical trial. The clinical trial can be associated with a clinical research organization and/or a sponsor. When the comparing produces a match between the demographics and the profile, a clinical trial can be identified as suitable for the patient.
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| Determining clinical trial candidates from automatically collected non-personally identifable demographics | 20120158420 | 20120621 |
| Non-personally identifiable demographics associated with a patient during a communication session can be collected. The patient can be associated with one or more healthcare providers which can be associated with a one or more healthcare professionals. The demographics can be compared against a clinical trial profile associated with a clinical trial. The clinical trial profile can specify one or more target group parameters associated with a target group of the clinical trial. The clinical trial can be associated with a clinical research organization and/or a sponsor. When the comparing produces a match between the demographics and the profile, a clinical trial can be identified as suitable for the patient. Related apparatus, methods, systems and articles are also described.
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| Systems and methods for clinical trial documenting using a mobile communications device | 20120143617 | 20120607 |
| Systems and methods presented herein may involve documenting clinical trials through use of a mobile communications device, such as a camera phone. Using the mobile communications device, the participant may record video of themselves administering a health intervention that is the subject of the clinical trial and/or report serious adverse events that occur. The video clips may be sent to a documentation server for documentation. The documentation server may also route serious adverse event notifications to a plurality of locations, such as the doctor's office, the study center, and/or the pharmaceutical company that developed the health intervention being tested.
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| Apparatus and method for gaining approval to conduct clinical trials and studies | 20120130746 | 20120524 |
| The present invention implements a computer-based system and procedure for the efficient and effective preparation for conducting at least one clinical trial. The various methods are deployed using a Software As A Service (“SaaS”) platform, allowing access to the system by all relevant participants. Each authorized participant in a proposed clinical trial may access a customized and customizable view of the data necessary to gain approval for conducting a clinical trial and interact with the other participants electronically, prior to initiation of a clinical trial or study. The various documents needed for the clinical trial or study, as well as the various compliance documents needed to satisfy regulatory agencies are all available for review via the Internet. By utilizing present invention, greater protection is offered for... |
| Method and system for recommending a decision based on combined entity modeling | 20120117021 | 20120510 |
| A method for improved, automated analysis of a data set improves the reliability of the data set by comparing the data set with a model of similar data. The method may be used in applications such as medical imaging, clinical trial participant selection, marketing, security, traffic control, and other applications.
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| A pkn3/rhoc macromolecular complex and methods of use therefor | 20120100561 | 20120426 |
| Disclosed are compositions comprising and methods of using a novel macromolecular assembly comprising PKN3, PDK1 and RhoC (PPRC complex). The PPRC complex was shown to have kinase activity and was found in cells of high malignancy potential, such as particularly aggressive cancers. In some aspects, the invention provides methods for screening compounds that have cancer therapeutic potential, methods for diagnosing aggressive cancer, methods for determining the prognosis of a patient suffering from cancer, methods for stratifying patients in a clinical trial or determining the effectiveness of a particular treatment regimen, polypeptides that modulate the formation of the PPRC complex, and kits comprising one or more components of the PPRC complex.
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| Systems and methods for managing clinical trial site visit reports | 20120101837 | 20120426 |
| Systems and methods are disclosed for managing site visit report creation. Data relationships and process flow rules can be utilized to output reminder messages regarding deadlines associated with a site visit report completion and determine and present proper questions to associates to elicit relevant information about a site visit. Site visit reports can be generated in an efficient and accurate manner and submitted quickly to a sponsor.
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| Systems and processes for managing and supporting regulatory submissions in clinical trials | 20120101838 | 20120426 |
| Systems and processes for managing and supporting clinical trials and clinical trial operations, more particularly for managing and supporting governmental authority, ethics committee, and/or other regulatory authority notifications and submissions in the context of clinical trials in various countries throughout the world. Such systems and processes leverage the insight that such regulatory authority requirements vary from one country to the next, but that all or essentially all such regulatory authority requirements can be categorized into a limited number of groups as to which a limited number of workflows can be created. Such workflows can be automated and supported with systems and processes according to embodiments of the invention, which can then control sequence of activities to comply with regulations and requirements in the various countries in... |
| System and method for anonymizing patient data | 20120101843 | 20120426 |
| A system and method for managing healthcare information is disclosed. The data servers each include a data manager that comprises a controller, a scrubber module and a user interface engine. The controller manages the core functions and the transmission of data between data manager components. The scrubber module manages the pseudoanonymization of data and the collection of data for clinical trials. The user interface engine generates user interfaces for displaying the applications and collecting clinical trial data.
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| Virtual care team record for tracking patient data | 20120101849 | 20120426 |
| A system and method for managing healthcare information is disclosed. The data servers each include a data manager that comprises a controller, applications, an application manager, a virtual care team module, and a user interface engine. The controller manages the core functions and the transmission of data between data manager components. The applications are applications that are created by the user or downloaded as third-party applications. The application manager manages the creation and communication between applications. The virtual care team module manages the transmission of patient data between data servers. The user interface engine generates user interfaces for displaying the applications and collecting clinical trial data.
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| Personalized monitoring and healthcare information management using physiological basis functions | 20110004110 | 20110106 |
| Analysis of individual's serial changes, also referred to as the physiological, pathophysiological, medical or health dynamics, is the backbone of medical diagnosis, monitoring and patient healthcare management. However, such an analysis is complicated by enormous intra-individual and inter-individual variability. To address this problem, a novel serial-analysis method and system based on the concept of personalized basis functions (PBFs) is disclosed. Due to more accurate reference information provided by the PBFs, individual's changes associated with specific physiological activity or a sequence, transition or combination of activities (for example, a transition from sleep to wakefulness and transition from rest to exercise) can be monitored more accurately. Hence, subtle but clinically important changes can be detected earlier than using other methods. A library of individual's PBFs and their transition... |
| Methods for the detection and quantitation of the p95 component of her2/neu (erbb2) | 20100332417 | 20101230 |
| The present disclosure relates generally to methods for the detection and quantitation of the p95 component of HER2/neu (ERbB2). Such methods may comprise assaying the biological sample for expression of HER2 ICD; assaying the biological sample for expression of a HER2 ECD; quantitating an expressed amount of the HER2 ICD and an expressed amount of the HER2 ECD in the biological sample; and determining the amount of p95 expressed in the biological sample based on a difference between the expressed amount of the HER2 ICD and the expressed amount of the HER2 ECD. The methods of the present disclosure may be used to predict whether a subject will be responsive to a receptor tyrosine kinase inhibitor and/or may be used to select subjects for inclusion/exclusion in... |
| Clinical trial navigation facilitator | 20100332258 | 20101230 |
| A method of improving clinical trial recruitment and retention includes creating patient trial scores based on ranking of patient traits or characteristics, creating patient clusters based on statistical similarity and allocating clinical trial navigation resources to patients groups based on need as indicated by cluster rankings.
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| Needle array assembly and method for delivering therapeutic agents | 20100330589 | 20101230 |
| A fluid delivery device includes an array of needles, each in fluid communication with a respective reservoir. Respective actuators are coupled so as to be operable to drive fluid from the reservoirs via needle ports. Each needle can have a plurality of ports, and the ports can be arranged to deliver a substantially equal amount of fluid at any given location along its length. A driver is coupled to the actuators to selectively control the rate, volume, and direction of flow of fluid through the needles. The device can simultaneously deliver a plurality of fluid agents along respective axes in solid tissue in vivo. If thereafter resected, the tissue can be sectioned for evaluation of an effect of each agent on the tissue, and based on... |
| Method and article of manufacture for performing clinical trial budget analysis | 20100324931 | 20101223 |
| An electronic method and article of manufacture is provided for analyzing clinical trial budgets. A clinical trial budget is input into a processor. The budget includes activities and associated activity costs of a clinical trial. The activities of the inputted clinical trial budget are classified into a set of standardized service categories. The processor is used to electronically allocate the associated activity costs with the respective standardized service category so that budget costs of the clinical trial can be objectively analyzed. A report of the associated activity costs with the respective standardized service category is outputted for use in analyzing budgets for clinical trials.
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| Methods and systems for response detection and efficacy | 20100312732 | 20101209 |
| Techniques are provided for analyzing clinical trial data and other medical information in order to understand heterogeneity of response within a population to a treatment under study. These techniques can support the development of personalized medical treatments and provide a better understanding of variability within the population to the effects of existing and new therapies. Additionally, these techniques can robustly define how subjects in the population respond to a treatment under study to differentiate between different responses, such as non-response and response followed by relapse. Therefore, the likely biology that is different in these responses can be identified to predict future response using any number of identified markers.
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| Methods for the detection and quantitation of pten | 20100303809 | 20101202 |
| The present disclosure provides methods for determining if PTEN is elevated or reduced in one or more tumor cells relative to one or more normal cells in the same biological sample by obtaining a biological sample comprising one or more tumor cells and one or more normal cells; assaying the biological sample for expression of PTEN; quantitating an amount of PTEN expression in the one or more tumor cells and an amount of PTEN expression in the one or more normal cells; comparing the amount of PTEN expression in the tumor cells to the amount of PTEN expression in the normal cells; and determining that PTEN is elevated in the tumor cells where the amount of expression of PTEN is greater in the tumor cells as... |
| Method for optimizing clinical data standardization | 20100299335 | 20101125 |
| A method of integrating clinical trial data into a form required by a standards based data format. Annotations may be made to a case report form (CRF) designed for a clinical trial that map report form data to standards compliant data. The annotations may be stored in, and then applied to data captured using that particular case report form to produce standards compliant data for that particular clinical trial. The data sets produced may then be validated as being standards compliant.
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| Meningococcal oligosaccharide linked polysaccharides and diptheria protein conjucate vaccine for all ages | 20100297166 | 20101125 |
| Methods for producing quadrivalent meningococcal meningitis polysaccharide and conjugate vaccines for serotypes A, C, Y and W-135 disclosed. Neisseria meningitidis fastidious medium was designed to maximize the yield of capsular polysaccharides and generate minimal cellular biomass and endotoxin in a short duration of fermentation. The crude polysaccharides are isolated, purified, and mechanically depolymerized by sonication. These purified polysaccharides were found in human clinical trials to be safe and immunogenic against meningococcal disease caused by N. meningitidis A, C, Y and W-135 serogroups in sub-Saharan Africa. In the preferred embodiment, the polysaccharides are conjugated to carrier proteins of diphtheria or tetanus toxoid to an average molecular size of 5100 to 9900 Daltons and provide broad spectrum protection to humans of all ages. Accelerated polysaccharide production and the... |
| Interactive psychophysiological profiler method and system | 20100292545 | 20101118 |
| An efficient, objective, flexible and easily deployable system for conducting evaluations of mental and physiological state and recommending individualized treatment to improve said state is described. The method and system are based on commensurate measurement of mental functions, levels of stress and anxiety, and/or biologically active molecules such as neurotransmitters, immune markers including cytokines and hormones. The method and system are designed to assess an individual's cognitive function and the underlying physiology in order to delineate various disease processes, injuries, drug states, training stages, fatigue levels, stress levels, aging processes, predict susceptibility to stress and/or sleep deprivation, identify aptitude for training and/or characterize effects of any experimental conditions. The system and method may be used in recommending individualized treatment protocols, as well as to guide the... |
| Systems for clinical trials | 20100280975 | 20101104 |
| The invention provides methods and systems for assessing the efficacy of a pharmaceutical which is putatively disease modifying of a cognitive disorder, for use in the treatment or prophylaxis of that cognitive disorder, the method comprising the steps of: (1) stratifying a subject group into at least 2 sub-groups according to a baseline indicator of likely disease progression, (2) treating members of each subject group with the pharmaceutical for a treatment time frame, (3) deriving psychometric and optionally physiological outcome measures for each treated patient group, (4) comparing the outcomes at (3) with a comparator arm of said sub-groups which is optionally a placebo or minimal efficacy comparator arm, (5) using the comparison in (4) to derive an efficacy measure for the pharmaceutical. The methods and... |
| Biomarkers for septic shock patients | 20100279878 | 20101104 |
| The instant invention relates generally to the use of IL-8 as a biomarker in septic shock patients as an indicator of the likelihood of survival. The instant invention further relates to the use of IL-8 as a biomarker in septic shock patients for the selection of appropriate therapies. The instant invention further relates to the use of IL-8 as a biomarker for the purposes of structuring, conducting, or evaluating clinical trials or data from clinical trials.
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| Novel clinical trial methods to improve drug development for disease therapy and prevention | 20100274495 | 20101028 |
| In one embodiment, a method for a multiplexed continuous biomarker clinical trial is disclosed that evaluates multiple drugs concurrently or subsequently against a continuously collected and enlarging control group with increasing statistical power.
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| Qualifying data and associated metadata during a data collection process | 20100268544 | 20101021 |
| Systems and methods for processing metadata associated with a clinical trial are described. In one aspect, a computing device receives collected data with embedded metadata. The device extracts the embedded metadata, and accesses a database to determine characteristics of the embedded metadata. The device then accesses protocol rules where the protocol rules are a set of data collection requirements and procedures for a given clinical trial. The device ensures compliance of the embedded metadata by comparing the characteristics of the embedded metadata with the protocol rules. The device then reports the compliance or non-compliance of the collected data.
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| System and method for facilitating candidate and subject participation in clinical trial studies | 20100250288 | 20100930 |
| The present invention discloses systems and methods for facilitating candidate and subject participation in clinical trial studies. Medical professionals participating in the study at satellite sites assist in recruitment of their pre-existing patients as subjects in the study. Clinical trial data collected from the subjects is communicated over a computer network from the satellite sites to core sites. Study coordination is performed at the core sites. The collected clinical trial data is analyzed in accordance with the study at an interested party site.
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| System and method for recruiting subjects for research studies and clinical trials over the internet | 20100250285 | 20100930 |
| A system and method for managing private records and other confidential information is provided, including a patient interface that allows patients to configure privileges for various parties to access various private records or portions thereof. A database can be accessed via a privacy engine, which respects the configured privileges and allows searching for private records. A plurality of user interfaces is provided to allow records managers, patients, and interested parties to access selected private information. A clinical trials interface allows limited access to a private records database for interested parties to identify germane clinical trials and research studies. A recruitment interface allows conductors of research studies to access private records to locate appropriate research subjects.
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| Site effectiveness index and methods to measure and improve operational effectiveness in clinical trial execution | 20100250273 | 20100930 |
| This invention provides a method of improving operational effectiveness in a clinical trial, the method comprises the steps of: obtaining historical clinical trial operation data for a disease condition; normalizing data from different clinical trials; grouping different clinical trials into groups; and calculating Site Effectiveness Index (SEI), wherein the SEI is useful for improving operational effectiveness in a clinical trial. In one embodiment, using the method disclosed herein would result in reducing the cost for the clinical trial.
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| Biomarkers for efficacy of aliskiren as a hypertensive agent | 20100240760 | 20100923 |
| A retrospective pharmacogenetic analysis was conducted in an attempt to evaluate potential association between genetic variation and outcome of a clinical trial of efficacy of aliskiren as an antihypertensive agent. Forty-eight polymorphisms were examined in twelve genes from the renin-angiotensin-aldosterone system (RAS) or previously implicated in blood pressure regulation. Significant associations were seen between one polymorphism in the angiotensin converting enzyme (ACE) gene, two polymorphisms in the angiotensin II type 2 receptor (AGTR2) gene, and clinical parameters of mean sitting diastolic and systolic blood pressure decrease. These effects were not found with irbesartan and placebo treatment, but instead were specific to aliskiren treatment.
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| Methods of determining patient response by measurement of her-2 expression | 20100233732 | 20100916 |
| Methods are provided for determining or otherwise assessing the response of a patient to treatment, in particular, to cancer treatment. The methods include the analysis of samples for the presence or the absence of HER2 markers alone or in conjunction with other biomarkers, such as HER3 markers. In certain examples, the probable time to progression can be determined by first determining HER2 positive patients and then further stratifying by using the presence or the absence of a second biomarker (e.g, HER3 markers). In addition, the data can be used to track a patient's response to a treatment regimen, assessing the expected success of treating a patient using a particular regiment, determining the effects of a treatment regiment or for categorizing a patient in order to create... |
| System and method for interacting with clinical trial operational data | 20100228699 | 20100909 |
| A method and system for exchanging clinical trial operational data by using a centralized shared server system connected to a plurality of shared servers. The system and method manage a plurality of clinical trial-related applications by creating a plurality of tables stored within the shared database of the shared database system connected to a centralized shared server system within a virtual network for updating and sharing among clinical trials. The current system and method allow exchanging clinical trial operational data between a centralized shared server system and a plurality of shared servers to delegate responsibility to other clinical trial organization users for producing subsets of clinical trial operational data with limited data access rights. The current system and method allow assigning data access rights to other... |
| Micelle encapsulation of therapeutic agents | 20100203114 | 20100812 |
| The invention provides 17 AAG encapsulated in micelle particles. The micelles can be comprised of safe poly(ethylene glycol)-block-poly(lactic acid) (PEG-PLA). A significant advantage of PEG-PLA as a carrier is that it is less toxic than Cremophor® EL or DMSO. Additionally, PEG-PLA micelles are easier to handle than DMSO and they do not possess foul odors, which is a problem associated with 17-AAG formulations currently in clinical trials. The invention also provides methods of preparing active agents encapsulated micelles and therapeutic methods of using the micelles and their corresponding formulations, such as for the inhibition of Hsp 90, and/or for the treatment of cancer.
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| Method and apparatus for time-lapse cryptography | 20100185863 | 20100722 |
| According to one aspect, provided is a construction and specification for an implementation of a new cryptographic primitive, “Time-Lapse Cryptography”, with which a sender can encrypt a message so that it is guaranteed to be revealed at an exact moment in the future, even if this revelation turns out to be undesirable to the sender. In one embodiment, a Time-Lapse Cryptography Service is provided (“the Service”) based on a network of parties. Senders encrypt their messages with this public key whose secret key is not known to anyone—not even a trusted third party—until a predefined and specific future time T+δ, at which point the secret key is constructed and published. In one example, the secret key can only be known after it is constructed. At or... |
| Automated identification of task items that must be completed before a clinical trial database can be locked | 20100185464 | 20100722 |
| An automated method is provided for generating summary data regarding task items that must occur to achieve a database lock for a clinical trial study that is performed based on a previously defined clinical trial protocol. The clinical trial study is managed using a processor and a database in communication with the processor. The database includes clinical trial data and the status of the data for a plurality of patients participating in the clinical trial study. At least one clinical database lock criterion is defined for the study from at least a plurality of user-selected subsets of the clinical trial data. The processor receives the at least one clinical database lock criterion for the study, and the clinical trial data and the status of the data,... |
| Method for analyzing clinical trial results for efficacy of a therapy | 20100185399 | 20100722 |
| Methods of identifying, monitoring and matching patients with appropriate treatments who are at risk for developing a systemic inflammatory condition using a systemic mediator-associated physiologic test profile are provided. The methods of the present invention increase the likelihood of demonstrating clinical efficacy in clinical trial datasets.
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| System for matching individuals with health care providers and methods thereof | 20100169115 | 20100701 |
| A system for matching individuals with health care providers and methods thereof. The system is capable of collecting information from health care providers and individuals and thereafter matching individuals with clinical trial providers based upon that information by utilizing coding to eliminate medical terminology ambiguity. The system continually updates the degree of likelihood of a match of a health care provider with an individual based upon individual feedback and clinical trial provider feedback relating to results achieved from treatment provided by a given health care provider. The system also notifies individuals of experimental clinical trials that can be potentially applicable to the individual based upon the information provided by the individual.
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| Techniques for purposing a new compound and for re-purposing a drug | 20100161301 | 20100624 |
| A method for repurposing a pharmaceutical compound. The method includes identifying a pharmaceutical compound, the pharmaceutical compound corresponding to a drug that has failed in clinical development or an approved drug. A mathematical model describing the physiological processes related to at least one disease and the effects of the pharmaceutical compound on the disease is created. The model is adjusted based upon information from preclinical or clinical trials. A new treatment protocol is suggested to salvage the failed drug or a new way to use an approved drug. The suggested treatment protocol is displayed. Systems and computer program products encompassing the above techniques are also disclosed.
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| Contactless and minimal-contact monitoring of quality of life parameters for assessment and intervention | 20100152543 | 20100617 |
| An apparatus, system, and method for the measurement, aggregation and analysis of data collected using non-contact or minimally-contacting sensors provides quality of life parameters for individual subjects, particularly in the context of a controlled trial of interventions on human subjects (e.g., a clinical trial of a drug, or an evaluation of a consumer item such as a fragrance). In particular, non-contact or minimal-contact measurement of quality-of-life parameters such as sleep, stress, relaxation, drowsiness, temperature and emotional state of humans may be evaluated, together with automated sampling, storage, and transmission to a remote data analysis center. One component of the system is that the objective data is measured with as little disruption as possible to the normal behavior of the subject. The system can also support behavioral... |
| Application of sedoisoprosan for preparation of medicine for treatment of human hbeag positive chronic hepatitis b | 20100144855 | 20100610 |
| The present invention disclosed the application of sedoisoprosan for preparation of medicine for therapy on human HBeAg positive chronic hepatitis B. Results of the clinical trials indicated that sedoisoprosan could effectively inhibit hepatitis B virus, the anti-virus effect is enhanced as the dose is increased and the incidence of adverse events is low. Thus, sedoisoprosan is safe and effective for therapy on human HBeAg positive chronic hepatitis B.
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| Method, system, and apparatus for clinical trial management over a communications network | 20100138235 | 20100603 |
| A centralized, online clinical study system configured to coordinate aspects of a clinical study can include a training module configured to evaluate whether users have completed training for selected workflows for the clinical study that are available from the clinical study system, and to provide training to registered users for the selected workflows. The system also can include a financial engine configured to determine when a participating site meets or exceeds a milestone of the clinical study and to initiate a payment to the participating site. Further, the system can include a module configured to receive and verify clinical research data and to designate the verified clinical research data as official source data for the clinical study.
... |
| Method for generating reference controls for pharmacogenomic testing | 20100137426 | 20100603 |
| Reference controls for use with pharmacogenomic testing, and methods for their identification, preparation, and use, are disclosed. The reference controls can confirm that pharmacogenomic testing correctly identifies individuals that do or do not have the mutation of interest, in both clinical trial and patient treatment settings. The reference controls can be selected to include one or more mutations to be identified, and prescreened to confirm that they bind to one or more of the primers used in the pharmacogenomic testing. The reference controls are human genomic DNA that includes certain identified polymorphisms (mutations) of interest, ideally derived from individuals, pre-selected and optionally properly consented, which have one or more of the polymorphism(s) of interest. The reference controls can be prepared by targeted pre-screening of human patients,... |
| System and method for interacting with clinical trial operational data | 20090319535 | 20091224 |
| The current method and system allow sharing and integrating clinical trial operational data for easy accessibility of operational data, reusable predefined field identifiers and operational data for context and tables, and centralized use of operational data for conducting clinical trials based on semantics as well as syntax for consistency. The current system and method manage a plurality of clinical trial-related applications by creating a plurality of tables stored within the shared database of the shared database system for updating and sharing among clinical trials. The tables are logically organized by a plurality of operational data, and each table contains predefined data field identifiers associated with the plurality of operational data. The current system and method configure the plurality of clinical trial-related applications associated with the plurality... |
| Agent for medical image transmission | 20090313170 | 20091217 |
| A downloadable agent facilitates medical image transmission in accordance with a clinical trial protocol. The agent includes program code for obtaining or receiving a medical image from a computer storage device or a DICOM-compliant diagnostic instrument, program code for accepting textual information about the patient or medical image and associating the textual information with the medical image to prevent dissociation of the textual information and the medical image, program code for executing a data compliance protocol, program code for encrypting the image and textual information and for compressing at least the image, and program code for transmitting the encrypted image and textual information across a wide area network to a remote translator for decompressing, de-encrypting and viewing of the image and textual information. The data compliance... |
| Clinical trials management system and method | 20090313048 | 20091217 |
| Clinical trials are defined, managed and evaluated according to an overall end-to-end system. The central authority creates protocol meta-models and makes them available to clinical trial protocol designers. Each meta-model includes a short list of preliminary patient eligibility attributes which are appropriate for a particular disease category. The protocol designer chooses the appropriate meta-model, and encodes the clinical trial protocol, including eligibility and patient workflow, within the selected meta-model. The resulting protocol database is stored together with databases of other protocols in a library of protocol databases. Sponsors and individual clinical sites have controlled access to the protocols. Study sites make reference to the pertinent protocol databases to which they have access in the protocol database library in order to perform patient eligibility screening. Once a... |
| System and method for medical research and clinical trial | 20090313045 | 20091217 |
| A system and methods for a network for medical research and clinical trials are provided. Methods and systems for setting-up a clinical trial have been disclosed. Methods and system for identifying and qualifying participants in a trial have also been disclosed. Methods and systems for the automatic collection, extraction, distribution and review of data are also provided. Integration of a healthcare transcription platform with a clinical trial system is also disclosed.
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| Injection fluid leakage collection system and method | 20090312722 | 20091217 |
| A system and method for collection of fluids, as may be used in evaluation of drag dose delivery completeness after parenteral injection by measuring fluid volume leakage from the injection site is provided. The system and method optionally separate the collection and measurement steps, which make the system and method easy to use in multi-site clinical trials, and for batch weighing operations.
... |
| Compositions and methods for the diagnosis and treatment of immune disorders | 20090304703 | 20091210 |
| In this regard, the invention provides methods for the identification and therapeutic use of compounds for treatments of immune disorders, especially TH cell subpopulation-related disorders and including TH2 and TH2-like disorders (i.e., disorders associated with a TH2 or TH2-like mediated immune response) such as atopic conditions (e.g., allergy and asthma). Additionally, methods are provided for the diagnostic evaluation and prognosis of TH cell subpopulation related disorders, for the identification of subjects exhibiting a predisposition to such conditions, for monitoring patients undergoing clinical evaluation for the treatment of such disorders and for monitoring the efficacy of compounds used in clinical trials.
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| Aplidine treatment of cancers | 20090298752 | 20091203 |
| Aplidine demonstrates considerable promise in phase (I) clinical trials for treatment of tumors, and various dosing regimes are given. Tumor reduction has been observed in several tumor types including renal carcinoma, colorectal cancer, lung carcinoid, medullary thyroid carcinomas and melanoma. It has also been found that aplidine has a role in inhibiting angiogenesis, complementing the anti-tumor activity.
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| Methods and apparatus for planning and management of clinical trials | 20090292554 | 20091126 |
| A tool for planning and management of clinical trials. The tool computes a patient enrollment timeline in a clinical trial using multiple factors that bear on the rate of patient enrollment. The factors may be site-dependent factors or may be country-dependent factors. When these factors are applied, different sites may have different rates of enrollment in the same interval. Further, the factors may be time dependent such that even the same sites may have different enrollment rates in different intervals. Once the timeline is created, the tool may use it to calculate a schedule of monitor visits, project trial completion or otherwise generate output used in management of the clinical trial.
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| Method of producing meningococcal meningitis vaccine for neisseria meningitidis serotypes a, c, y, and w-135 | 20090258397 | 20091015 |
| Methods for producing quadrivalent meningococcal meningitis polysaccharide and conjugate vaccines for serotypes A, C, Y and W-135 disclosed. Neisseria meningitidis fastidious medium was designed to maximize the yield of capsular polysaccharides and generate minimal cellular biomass and endotoxin in a short duration of fermentation. The crude polysaccharides are isolated, purified, and mechanically depolymerized by sonication. These purified polysaccharides were found in human clinical trials to be safe and immunogenic against meningococcal disease caused by N. meningitidis A, C, Y and W-135 serogroups in sub-Saharan Africa. In the preferred embodiment, the polysaccharides are conjugated to carrier proteins of diphtheria or tetanus toxiod to an average molecular size of 5100 to 9900 Daltons and provide broad spectrum protection to humans of all ages. Accelerated polysaccharide production and the... |
| Human monoclonal anti-ctla4 antibodies in cancer treatment | 20090252741 | 20091008 |
| Although results from preclinical studies in animal models have proven the concept for use of anti-CTLA-4 antibodies in cancer immunotherapy, two major obstacles have hindered their successful application for human cancer therapy. First, the lack of in vitro correlates of the anti-tumor effect of the antibodies makes it difficult to screen for the most efficacious antibody by in vitro analysis. Second, significant autoimmune side-effects have been observed In a recent clinical trial. In order to address these two issues, we have generated human CTLA-4 gene knock-in mice and used them to compare a panel of anti-human CTLA-4 antibodies for their ability to induce tumor rejection and autoimmunity. Surprisingly, while all antibodies induced protection against cancer and demonstrated some autoimmune side effects, the antibody that induced the... |
| Human monoclonal anti-ctla4 antibodies in cancer treatment | 20090252741 | 20091008 |
| Although results from preclinical studies in animal models have proven the concept for use of anti-CTLA-4 antibodies in cancer immunotherapy, two major obstacles have hindered their successful application for human cancer therapy. First, the lack of in vitro correlates of the anti-tumor effect of the antibodies makes it difficult to screen for the most efficacious antibody by in vitro analysis. Second, significant autoimmune side-effects have been observed In a recent clinical trial. In order to address these two issues, we have generated human CTLA-4 gene knock-in mice and used them to compare a panel of anti-human CTLA-4 antibodies for their ability to induce tumor rejection and autoimmunity. Surprisingly, while all antibodies induced protection against cancer and demonstrated some autoimmune side effects, the antibody that induced the... |
| Method for discovering new uses of pharmaceutical products through assessment of beneficial side effects in clinical trials | 20090240635 | 20090924 |
| A method for discovering new indications of any pharmaceutical product through systematically assessing the beneficial side effects of it directly from patients and their care takers in clinical trials, without first specifying what those effects might be. One embodiment of the method ensures that all collected beneficial side effects can be coded with a standard dictionary for adverse events, and that all important aspects of them are captured and summarized. The beneficial side effect data collected and analyzed will lead to more and faster discoveries of new indications and better understanding of pharmaceutical products. It is especially promising for diseases that are least understood or least researched. The standard animal-to-human drug research and development model does not work when a drug works in only humans, not... |
| In vitro assay methods for classifying embryotoxicity of compounds | 20090220996 | 20090903 |
| The present disclosure provides methods useful for screening compounds and/or compositions, for example potential drug candidates. The results of the screening assays correlate to the effects of the compounds on the molecular and/or cellular level of the human body. Also disclosed are screening assays utilizing human embryonic stem cells RELICELL®hES of Indian origin. The methods disclosed herein correlate well with animal preclinical toxicity studies done in a clinical trial setup.
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| Method for collecting and assigning patient data in a clinical trial | 20090216139 | 20090827 |
| A method for assigning an ECG for purposes of conducting a clinical trial is disclosed herein. The method includes assigning an ECG to a primary reader, selectively reassigning the ECG to the primary reader, and selectively assigning the ECG to a secondary reader. The method also includes automating the assignment of the ECG to a primary reader, automating the selective reassignment of the ECG to the primary reader, and/or automating the selective assignment of the ECG to a secondary reader in order to minimize manual labor requirements.
... |
| Method for collecting and assigning patient data in a clinical trial | 20090216139 | 20090827 |
| A method for assigning an ECG for purposes of conducting a clinical trial is disclosed herein. The method includes assigning an ECG to a primary reader, selectively reassigning the ECG to the primary reader, and selectively assigning the ECG to a secondary reader. The method also includes automating the assignment of the ECG to a primary reader, automating the selective reassignment of the ECG to the primary reader, and/or automating the selective assignment of the ECG to a secondary reader in order to minimize manual labor requirements.
... |
| Method for collecting and assigning patient data in a clinical trial | 20090216139 | 20090827 |
| A method for assigning an ECG for purposes of conducting a clinical trial is disclosed herein. The method includes assigning an ECG to a primary reader, selectively reassigning the ECG to the primary reader, and selectively assigning the ECG to a secondary reader. The method also includes automating the assignment of the ECG to a primary reader, automating the selective reassignment of the ECG to the primary reader, and/or automating the selective assignment of the ECG to a secondary reader in order to minimize manual labor requirements.
... |
| Method for collecting and assigning patient data in a clinical trial | 20090216139 | 20090827 |
| A method for assigning an ECG for purposes of conducting a clinical trial is disclosed herein. The method includes assigning an ECG to a primary reader, selectively reassigning the ECG to the primary reader, and selectively assigning the ECG to a secondary reader. The method also includes automating the assignment of the ECG to a primary reader, automating the selective reassignment of the ECG to the primary reader, and/or automating the selective assignment of the ECG to a secondary reader in order to minimize manual labor requirements.
... |
| Method for collecting and assigning patient data in a clinical trial | 20090216139 | 20090827 |
| A method for assigning an ECG for purposes of conducting a clinical trial is disclosed herein. The method includes assigning an ECG to a primary reader, selectively reassigning the ECG to the primary reader, and selectively assigning the ECG to a secondary reader. The method also includes automating the assignment of the ECG to a primary reader, automating the selective reassignment of the ECG to the primary reader, and/or automating the selective assignment of the ECG to a secondary reader in order to minimize manual labor requirements.
... |
| Method and article of manufacture for performing clinical trial budget analysis | 20090204431 | 20090813 |
| An electronic method is provided of analyzing budgets for clinical trials. A clinical trial budget is entered into a processor. The budget includes activities and associated activity costs. The activities are classified into a set of standardized service categories. The processor then electronically allocates the associated activity costs with the respective standardized service category so that budget costs can be objectively analyzed. The budget further includes assumption specifications. The processor further calculates per unit costs of the assumption specifications. The activities and the associated activity costs are then equalized against reference assumption specifications using at least the per unit costs via calculations performed in the processor.
... |
| Method for generating reference controls for pharmacogenomic testing | 20090197945 | 20090806 |
| Reference controls for use with pharmacogenomic testing, and methods for their identification, preparation, and use, are disclosed. The reference controls can confirm that pharmacogenomic testing correctly identifies individuals that do or do not have the mutation of interest, in both clinical trial and patient treatment settings. The reference controls can be selected to include one or more mutations to be identified, and prescreened to confirm that they bind to one or more of the primers used in the pharmacogenomic testing. The reference controls are human genomic DNA that includes certain identified polymorphisms (mutations) of interest, ideally derived from individuals, pre-selected and optionally properly consented, which have one or more of the polymorphism(s) of interest. The reference controls can be prepared by targeted pre-screening of human patients,... |
| Method, system, and apparatus for statistical evaluation of antihypertensive treatment | 20090192392 | 20090730 |
| A novel method, system, and apparatus—the RDH Method—for evaluating antihypertensive treatment efficacy across patient populations is disclosed. In accordance to one embodiment, the RDH is a population vector index and graphical method that provides the means for the statistical assessment of antihypertensive treatment reduction, duration, and homogeneity using ambulatory blood pressure monitoring (ABPM). The population RDH was specifically designed as a tool to evaluate and compare blood pressure (BP) coverage offered by antihypertensive drugs over 24 h in populations. In accordance to one embodiment, the population RDH is a three-component vector index that incorporates information about the reduction, duration, and homogeneity of antihypertensive treatment, as well as their statistical significance over the 24 h period. In the preferred embodiment, the population RDH components quantify: 1) the... |
| Methods for conducting a clinical trial | 20090164240 | 20090625 |
| The present disclosure relates generally to methods for selecting subjects for a clinical trial and includes methods for conducting a clinical trial to study the efficacy and/or safety of a drug by selecting subjects, for inclusion in a subsequent double-blind treatment period of the clinical trial, that do not exhibit adverse events to the drug. Methods for conducting a clinical trial may comprise the following: (1) an open-label titration period, (2) an adjustable dose treatment period and (3) a fixed dose treatment period. Optionally, the clinical trial may comprise a washout period prior to the open-label titration period. Also provided are methods for doing business by selecting subjects for a clinical trial for a drug that do not exhibit adverse events to the drug. Such methods... |
| Methods for conducting a clinical trial | 20090164240 | 20090625 |
| The present disclosure relates generally to methods for selecting subjects for a clinical trial and includes methods for conducting a clinical trial to study the efficacy and/or safety of a drug by selecting subjects, for inclusion in a subsequent double-blind treatment period of the clinical trial, that do not exhibit adverse events to the drug. Methods for conducting a clinical trial may comprise the following: (1) an open-label titration period, (2) an adjustable dose treatment period and (3) a fixed dose treatment period. Optionally, the clinical trial may comprise a washout period prior to the open-label titration period. Also provided are methods for doing business by selecting subjects for a clinical trial for a drug that do not exhibit adverse events to the drug. Such methods... |
| System and method for facilitating candidate and subject participation in clinical trial studies | 20090150187 | 20090611 |
| The present invention discloses systems and methods for facilitating candidate and subject participation in clinical trial studies. Medical professionals participating in the study at satellite sites assist in recruitment of their pre-existing patients as subjects in the study. Clinical trial data collected from the subjects is communicated over a computer network from the satellite sites to core sites. Study coordination is performed at the core sites. The collected clinical trial data is analyzed in accordance with the study at an interested party site.
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| Method, apparatus and solftware for identifying responders in clinical environment | 20090150180 | 20090611 |
| A process for determining responders in clinical testing environments that involves, inter alia, detecting treatment response through the use of small numbers of measurements of randomly varying outcome variables in individual clinical trial subjects, and by analyzing the measurements in such a way as to eliminate troublesome variables, such as a spontaneous population variability.
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| Method | 20090134211 | 20090528 |
| The present invention relates to a method for the provision of clinical trial products in the context of clinical trials.
... |
| Chronic lymphocytic leukemia prognosis and treatment | 20090136496 | 20090528 |
| Provided herein are methods for identifying a subject afflicted with chronic lymphocytic leukemia who is responsive to treatment with a chemotherapeutic agent by detecting the presence or absence of at least one APOE4 allele in the subject, the presence of an APOE4 allele identifying the subject as responsive to the treatment. Also provided are methods of treating a subject afflicted with chronic lymphocytic leukemia, including administering an estrogenic agent, an androgen withdrawal agent, an apoE4 peptide or mimetic thereof, and/or a chemotherapeutic agent in an amount effective to treat said chronic lymphocytic leukemia. Methods of determining a prognosis for a patient diagnosed with chronic lymphocytic leukemia are also provided. In addition, methods for stratifying a subject into a subgroup of a clinical trial and methods for... |
| Method for screening hiv drug sensitivity | 20090130654 | 20090521 |
| A method for monitoring ARV resistance, to determine viral fitness, and to forecast possible drug failure utilizes two nucleic acid sequences. One nucleic acid includes a retroviral nucleic acid devoid of at least a majority of the sequence for one of the two long terminal repeat regions. A second nucleic acid, includes a retroviral nucleic acid sequence devoid of the sequences encoding an envelope gene and the second long terminal repeat region of the retrovirus. The method allows the rapid cloning of an amplicon into an HIV-1 genome vector through recombination/gap repair in organisms such as yeast. The vectors can be directly passed to a mammalian cell line which has been specifically engineered to produce replication competent HIV-1 particles. The susceptibility of an isolate to any... |
| System and method for facilitating centralized candidate selection and monitoring subject participation in clinical trial studies | 20090132288 | 20090521 |
| A system and method of facilitating centralized and standardized remote ratings of subjects in clinical trial studies includes providing training to raters located at one or more central rating sites such that the raters are trained to apply substantially similar criteria in determining whether a candidate is a qualified subject for the clinical trial and/or in the actual assessment, or information collection, phase of the clinical trail. By having centralized, consistently trained raters that are independent of clinical trial investigators, inter-rater reliability is enhanced and potential bias is reduced, thus increasing the effectiveness of the clinical trial results by providing more qualified subjects and more accurate results.
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| Pay for studies submitted (pass) method for clinical trials | 20090112619 | 20090430 |
| A system and method is disclosed for facilitating the acquisition of medical images used as part of a clinical trials process by requiring Imaging Centers to compete with each other to supply the images. Agreements between the Sponsor and a plurality of Imaging Centers stipulate that the Sponsor is only required to accept a certain total number of medical images and is free to reject any medical images that either do not comply with the protocol, or which exceed the total number of medical images required for the study. This motivates the Imaging Centers to quickly obtain and transmit to the Sponsor high quality medical images that meet the basic requirements outlined in the clinical study protocol, since images are accepted and compensated for by the... |
| Method of producing meningococcal meningitis vaccine for neisseria meningitidis serotypes a, c, y, and w-135 | 20080318285 | 20081225 |
| Methods for producing quadrivalent meningococcal meningitis polysaccharide and conjugate vaccines for sero types A, C, Y and W-135 disclosed. Neisseria meningitidis fastidious medium was designed to maximize the yield of capsular polysaccharides and generate minimal cellular bio mass and endotoxin in a short duration of fermentation. The crude polysaccharides are isolated, purified and mechanically depolymerized by sonication. These purified polysaccharides were found in human clinical trials to be safe and immunogenic against meningococcal disease caused by N. meningitidis A, C, Y and W-135 sero groups in sub-Saharan Africa. In the preferred embodiment, the polysaccharides are conjugated to carrier proteins of diphtheria or tetanus toxoid to an average molecular size of 5100 to 9900 Daltons and provide broad spectrum protection to humans of all ages. Accelerated polysaccharide... |
| Methods for monitoring patients with severe sepsis and septic shock and for selecting treatments for these patients | 20080311554 | 20081218 |
| Methods of identifying, monitoring and matching patients with appropriate treatments who are at risk for developing a systemic inflammatory condition using a systemic mediator-associated physiologic test profile are provided. The methods of the present invention increase the likelihood of demonstrating clinical efficacy in clinical trial datasets.
... |
| Computer system and method for training certifying or monitoring human clinical raters | 20080312958 | 20081218 |
| A method and system are disclosed for computerized training, monitoring, certification or re-certification of human raters in clinical trials. The invention provides an interactive computerized interview that can be compared scores obtained by human raters to monitor and train clinical raters on a continuing basis in order to reduce rater drift and variance during clinical trials. Remediation can be automatically flagged or provided to improve a deviating rater's performance. Computerized assessment of symptom severity is provided without the need for human clinical raters. The system and method enable screening of prospective patients for inclusion or exclusion from a clinical trial by automatically obtaining computerized ratings of symptom severity.
... |
| Determining cancer-linked genes and therapeutic targets using molecular cytogenetic methods | 20080305493 | 20081211 |
| Methods for identifying antineoplastic agents by using their ability to modify expression of specific genes or the biological activity of polypeptides encoded by such genes, wherein said genes are located in specific chromosomal regions, called amplicons, or regions of interest, and the presence of such amplified regions within a cancerous cell, are disclosed. Also described are methods for diagnosing cancerous, or potentially cancerous, conditions using these methods. Also encompassed are methods involving determining the modulated expression of the genes in these regions of interest (ROIs), or amplicons, as pharmacodynamic/pharmacogenetic/surrogate markers and/or for patient profiling prior to accrual for clinical trials/treatments based on the identification of these genes as validated gene/drug targets in various cancer tissue types.
... |
| Genetic basis of treatment response in depression patients | 20080299125 | 20081204 |
| The invention provides a collection of polymorphic sites associated with response to treatment by an SSRI or placebo in depression patients. The polymorphic sites and others in linkage disequilibrium with them are useful in determining whether to treat a patient with an SSRI or include a patient in a clinical trial to test an SSRI.
... |
| Method of performing clinical trial budget analysis | 20080288285 | 20081120 |
| A computer-implemented method is provided of analyzing budgets for clinical trials. A clinical trial budget is entered into a processor. The budget includes activities and associated activity costs. The activities are classified into a set of standardized service categories. The processor then allocates the associated activity costs with the respective standardized service category. The budget further includes assumption specifications. The processor further calculates per unit costs of the assumption specifications. The activities and the associated activity costs are then equalized against reference assumption specifications using at least the per unit costs.
... |
| Managing potential clinical trial participants | 20080281826 | 20081113 |
| A method for managing information on potential participants in clinical research trials is disclosed. The method and system include populating a centralized secure database with information on a contact from the contact's response content or referral content, assigning investigative responsibility for the contact to an investigator, and providing the investigator access to the information of the contact through a secure web portal.
... |
| Method and system for collection, validation, and reporting of data and meta-data in conducting adaptive clinical trials | 20080270181 | 20081030 |
| A method and system are described for centrally managing data in an adaptive clinical trial or other adaptive process that is conducted at a plurality of geographically remote sites. The invention includes (1) flexible means for collecting data from remote sites; (2) processing, tracking, and validating such data and meta-data at a processing location; (3) interacting between central and remote sites to manage and resolve data discrepancies (4) reporting data to managers and remote sites; and (5) facilitation of special services to clinical research such as flexible randomization of patients, patient participation eligibility verification and double-blind trials. The invention is of particular relevance to adaptive clinical trials and other applications that demand the ability to quickly collect, process, and respond to various forms of data in... |
| Method and system for verification of source data in pharmaceutical studies and other applications | 20080270420 | 20081030 |
| A method and system are described for verifying database entries against corresponding source data collected at a plurality of geographically remote field locations. The invention provides an electronic means of verifying field data in a manner that is quicker, less labor-intensive and less error-prone as compared with existing methods. The invention is particularly useful in the conduct of adaptive clinical trials of pharmaceutical products.
... |
| Preventing arrhythmias associated with cell transplantation | 20080260705 | 20081023 |
| Skeletal myoblasts are an attractive cell type for transplantation since they are autologous and resistant to ischemia. However, clinical trials of myoblasts transplantation in heart failure have been plagued by ventricular tachy-arrhythmias and sudden cardiac death. The pathogenesis of these arrhythmias is poorly understood, but may be related to the fact that skeletal muscle cells, unlike heart cells, are electrically isolated by the absence of gap junctions. An in vitro model of myoblasts transplantation into cardiomyocyte monolayers can be used to investigate the mechanisms of transplant-associated arrhythmias. Co-cultures of human skeletal myoblasts and rat cardiomyocytes result in reentrant arrhythmias (spiral waves) that reproduce the features of ventricular tachycardia seen in patients receiving myoblasts transplants. These arrhythmias can be terminated by nitrendipine, an L-type calcium channel Mocker,... |
| Method for determining insulin sensitivity and glucose absorption | 20080262745 | 20081023 |
| The present invention encompasses a model-based method for determining insulin sensitivity and glucose absorption from oral glucose tolerance tests or mixed meals. The present invention has several advantages over current methods. The technique requires about four to six blood samples taken over about two to three hours following glucose ingestion and is therefore applicable to large-scale clinical trials. The analysis involves a reduced version of the classical minimal model, a method for describing glucose absorption using only two parameters, and an integral approach enabling the parameters to be obtained using simple algebra. The present method robustly identifies differences in insulin sensitivity in different patient types as well as improvements in insulin sensitivity arising from pharmaceutic therapy. In addition, insulin sensitivity measurements obtained with the present method... |
| Method and system for managing specimen data | 20080263138 | 20081023 |
| An innovative system and method for laboratories, hospitals and others to manage stored specimens is described and claimed. One problem commonly encountered by medical researchers is the inability to effectively and efficiently track the large number of specimens generated in the course of their research. In an environment comprised of multiple researchers—each working on varied projects and often needing to interact—it is necessary to employ a centralized, fast and efficient way to track the location of stored samples and to identify changes or removed samples. A Method and System for Managing Specimen Data (or “VSM”) is a web-based software application designed to efficiently manage specimen samples. Examples of the VSM include the VSM software application and a database—each residing on a remote server—that displays web pages... |
| Clinical trial phase simulation method and clinical trial phase simulator for drug trials | 20080256006 | 20081016 |
| A clinical trial phase simulation method for drug trials, which method allows to predict the trend of the results of a clinical trial phase of a drug with the steps of providing a database comprising for each of a certain number of individuals a predefined number of independent variables each of which corresponds to a certain clinical parameter relevant or characteristic for a disease condition against which the drug to be tested is oriented and at least a further independent variable describing the specific treatment to which the individual has been subjected between at least two different treatments one with the said drug and the second with a placebo or with another known drug, the database comprising also for each individuals one or more dependent variables... |
| Systems and methods for source document management in clinical trials | 20080256128 | 20081016 |
| System and methods for source documents management in clinical trials are described. One described method comprises receiving a clinical trial form on a client device over a network from a server device, the clinical trial form comprising a plurality of form data fields; receiving structured clinical trial data associated with at least one of the plurality of form data fields; receiving unstructured clinical trial data; and transmitting the structured clinical trial data and unstructured clinical trial data to the server over the network.
... |
| Methods of screening compounds to predict toxicity and residual proliferative and differentiation capacity of the lympho-hematopoietic system | 20080248503 | 20081009 |
| The present invention relates generally to kits that provide reagent mixes and instructions for the use thereof, in performing high-throughput assay methods that provide a method of screening compounds for cytotoxicity or other effects on target cell populations of the lymphohematopoietic system, including specific lineages. The methods measure the luminescent output derived from the intracellular ATP content of incubated target cells, and correlate the luminescence with the proliferative status of the cells. The methods may be used to predict the effect of virtually any compound on the lymphohematopoietic system and may be performed on multiple species simultaneously, thereby providing valuable information regarding potential cytotoxicity prior to preclinical studies and especially, patient clinical trials. The methods also provide the ability to screen compounds early in the drug... |
| Methods and systems for allocating representatives to sites in clinical trials | 20080243584 | 20081002 |
| Methods and systems for allocating representatives, such as clinical research associates (CRAs), to sites. One embodiment comprises a method for allocating CRAs to sites by determining for each CRA the first segment travel time from a starting location to a first node associated with a CRA, and the second segment travel time from the first node to a plurality of second nodes, wherein each second node is geographically associated with a site, determining the third segment travel time from each second hub to its corresponding site(s), for each CRA determining the aggregate travel time to each site by adding at least the first, second and third travel segments, for at least some of the CRAs and at least some of the sites, evaluating the aggregate travel... |
| Method of conducting a clinical trial | 20080221921 | 20080911 |
| Disclosed are methods of conducting and assessing the outcomes of a randomized controlled clinical trial. The method comprises the steps of: trialing, with respect to a first group of patients as an experimental group, an experimental treatment; and trialing, with respect to a second group of patients as a control group, at least first and second control therapies. The control therapies will have been previously validated or are a known standard of care. This method is described in relation to trialing and assessing implantable medical devices such as left ventricular assist devices (LVAD) but may be used for trialing and assessing other medical devices.
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| System and method for targeted healthcare messaging | 20080208628 | 20080828 |
| A system and method for targeted healthcare messaging is provided. The system includes a central targeted messaging server for receiving targeted advertisements or messages, such as information about one or more clinical trials, from a plurality of data sources, a notification database for storing the targeted messages and associated, pre-defined criteria, and a web server which can communicate with a plurality of message requesters to receive requests for targeted messages and to convey same to the plurality of message requesters. A customized web site could be provided for allowing vendors (e.g., pharmaceutical companies, etc.) to upload targeted message text files and/or voice files to the system of the present invention. In response to prescription-related activity, requests for targeted messages are transmitted by the plurality of message... |
| Methods for diagnosing and treating hemostatic disorders by modulating p-selectin activity | 20080193949 | 20080814 |
| The present invention identifies P-selectin as a modulator of hemostasis. Accordingly, the present invention relates to methods for the identification and use of modulators of P-selectin activity as modulators of hemostasis. The invention also relates to methods and compositions for the diagnosis and treatment of hemostatic disorders, including, but not limited to, hemorrhagic disorders and thrombotic disorders. The present invention describes methods for the diagnostic evaluation and prognosis of various hemostatic conditions, and for the identification of subjects exhibiting a predisposition to such conditions. In addition, the present invention provides methods for the diagnostic monitoring of patients undergoing clinical evaluation for the treatment of a hemostatic or vascular disorders, and for monitoring the efficacy of compounds in clinical trials.
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| Indole compound and use thereof | 20080188532 | 20080807 |
| a salt thereof, a solvate thereof, or a prodrug thereof, which has a leukotriene receptor antagonistic activity which is expected to be more effective than those of the leukotriene receptor antagonists currently used in clinical trials. Therefore, it is useful as an agent for the prevention and/or treatment of a leukotriene-mediated disease such as a respiratory diseases such as bronchial asthma, chronic obstructive pulmonary disease, pulmonary emphysema, chronic bronchitis, pneumonia (e.g. interstitial pneumonia etc.), severe acute respiratory syndrome (SARS), acute respiratory distress syndrome (ARDS), allergic rhinitis, sinusitis (e.g. acute sinusitis, chronic sinusitis, etc.), or the like, or as an expectorant or an antiitussive.
... |
| Salivary analysis | 20080183101 | 20080731 |
| The present invention relates to the multivariate analysis of spectra from saliva for estimating the oral health of an individual or group of individuals. The technique enables rapid sampling and evaluation and is particularly useful for facilitating the screening and monitoring of participants in clinical trials, and for evaluating developmental treatment products, as well as providing a straightforward, non-invasive diagnostic method.
... |
| Methods and systems for site startup | 20080183498 | 20080731 |
| Certain embodiments of the present invention provide clinical site information to clinical trial managers to support clinical trial management. One embodiment is a method for providing information in response to an inquiry. A plurality of site attributes is received. The site attributes can include information regarding the sites that may include clinical trial history, identification, or other site information. Each site attribute includes data elements that are associated with clinical trial sites. A site attribute is identified and a score is determined for each data element of the identified site attribute. An inquiry for clinical trial site information is received. The plurality of data elements are searched to identify at least one clinical trial site based on the inquiry. Information associated with the identified at least... |
| Ocular inserts containing apomorphine | 20080171072 | 20080717 |
| A gelatin-based insert was designed to deliver apomorphine by the ocular route. A clinical trial showed the product to have an efficacy similar to intravenously-administered apomorphine with a better safety profile in terms of adverse effects.
... |
| Monitoring z-values for clinical data interpretation | 20080172182 | 20080717 |
| Clinical data that are measured at a plurality of sequential time points are interpreted by monitoring the Z-value of the clinical data. The Z-value of the measured data is calculated at each of the time points. The calculated Z-values are plotted and compared against a pre-selected Z-value, which may be Z=5, in one exemplary embodiment. The clinical data are determined to have undergone a statistically significant change, compared to a baseline value BV of the data, when the calculated Z-value for the measured data is greater than or substantially equal to the pre-selected Z-value. In this way, signal detection from biomarker data may be enhanced. Also, the toxicity level of drugs that are tested in clinical trials may be determined in a more reliable fashion.
... |
| Self-organizing maps in clinical diagnostics | 20080161652 | 20080703 |
| The present invention provides methods for the diagnosis of a disease or condition in an individual. The methods employ a primary self-organizing map trained with biological marker profiles from tissues having known diseases or conditions, in combination with a secondary self-organizing map which displays a representation of a subset of the primary self-organizing map with sample data obtained from an individual in need of diagnosis. A result is prepared from the secondary SOM(s) that reveals the extent of similarity between the known diseases or conditions with the sample data set of the individual. The result can be provided to a practitioner to aid in the diagnosis or prognosis of the individual. The result can additionally be used to select an individual for a clinical trial to... |
| Method and system or managing ecgs in a clinical trial | 20080161704 | 20080703 |
| The present disclosure includes a method and system for managing ECGs in a clinical trial including a processor, storage media, ECG acquisition system, user interface device, and the appropriate databases configured to collect and store a set of trial specific drug ECG recordings. The system and method allows a trial administrator to select a set of placebo ECG recordings and a set of known QT prolonged ECG recordings from databases and adjust these sets according to the parameters of the study. Interpretations are made on this superset of ECG recordings and the interpretation is outputted to a user.
... |
| System and method for processing of clinical trial data for multiple clinical trials through associated trial ids | 20080162229 | 20080703 |
| A system and method for processing clinical trial data in a network communication environment according to a trial protocol. The trial protocol defining a plurality of data quality requirements and analysis functions for use in processing the clinical trial data, the method comprising: accessing a plurality of the trial protocols defining a plurality of respective clinical trials; receiving an update from the communication network for said trial protocol of the plurality of trial protocols, the update for amending at least one of the data quality requirements or analysis functions; receiving a trial dataset from the communication network having a trial ID for identifying at least one of the plurality of the trial protocols, the trial dataset including patient image data and identification data for at least... |
| Aggregation of compartmentalized clinical trial data | 20080154640 | 20080626 |
| Embodiments of the present disclosure include a system and method of compartmentalizing some or all aspects of clinical trial data acquisition and management. Moreover, embodiments include aggregation of the compartmentalized trial data to perform business metrics, trial interaction studies, and the like.
... |
| Physiological and environmental monitoring systems and methods | 20080146892 | 20080619 |
| Systems and methods for monitoring various physiological and environmental factors, as well as systems and methods for using this information for a plurality of useful purposes, are provided. Real-time, noninvasive health and environmental monitors include a plurality of compact sensors integrated within small, low-profile devices. Physiological and environmental data is collected and wirelessly transmitted into a wireless network, where the data is stored and/or processed. This information is then used to support a variety of useful methods, such as clinical trials, marketing studies, biofeedback, entertainment, and others.
... |
| Patient monitoring via image capture | 20080140444 | 20080612 |
| A system that can enable clinical trial compliance determination by viewing sequences of images captured during an event is disclosed. For example, the innovation can employ captured event sequences to enable a subject or third party to assess a subject's actions related to a medical trial. The capture of event sequences can be triggered based upon sensory data, radio frequency identification (RFID) data, pattern recognition data, etc. The system also provides mechanisms to locate images or sequences, playback images or sequences or images as well as to set compliance parameters associated with a particular clinical trial.
... |
| Clinical trial data processing system | 20070292012 | 20071220 |
| A system compares clinical trial protocol data in a configuration file with medical image metadata and data exchange protocol header data and in response generates a message to a user. A patient clinical image data processing system comprises a first validation processor for parsing a message conveying patient medical image data to identify image metadata indicating first characteristics of the image. The first validation processor performs a first comparison by comparing the metadata with configuration data indicating predetermined characteristics of images required for a particular use and indicating the image is acceptable for the use in response to a successful first comparison. A second validation processor parses header data of DICOM compatible data representing the image to identify image metadata indicating second characteristics of the image.... |
| Assay for efficacy of histone deacetylase inhibitors | 20070292351 | 20071220 |
| The invention provides methods for assessing the efficacy of histone deacetylase inhibitors using biomarkers which can be used in human clinical trials and which are more quantitative, easy to be used and more relevant to clinical outcome for PD monitoring than existing assays. The method according to the invention utilizes biomarkers from blood cells from patients treated with HDAC inhibitors which are easy to assay.
... |
| Medicine research information collection system and medicine research information collection program | 20070276694 | 20071129 |
| [Solving Means] The present invention relates to a medicine research information collection form 20 for medicine research requiring statistical processing for verifying validity of research results obtained from electronic input information generated based on handwritten information on a medicine research case. The medicine research information collection form 20 of the present invention is a sheet of paper having a printed position encoding pattern P for deciding a coordinate position of an electronic pen 10 on the paper. Furthermore, the sheet of paper has a printed item for handwriting or selecting information on medicine research such as a clinical trial.
... |
| Clinical trail support system using medical imaging information | 20070271214 | 20071122 |
| A clinical trial support system suitable for the investigation of an adverse event or the like. A clinical trial database stores: information about sponsors; information about trial sites; product information including the product names, classification, chemical structure, and pharmacokinetics of trial drugs; trial information including trial name, target disease, phase, and completed status; contract information including trial site name, contracted number of cases, and completed status; trial subject information including sex, birth of date, height, weight, and completed status; and visit information including visit date, inspection result, and medical imaging data. An information control unit distributes a search interface for the analysis of an adverse event to the trial sponsor and a retrieval result to the trial site.
... |
| Xml application for the generation of clinical trial forms | 20070265881 | 20071115 |
| A clinical analytics system is disclosed. A method for generating and displaying a patient form includes retrieving an XML file from a computer-readable medium. The XML file details data and structure of the patient form. The XML file is processed by running an XML-responsive application. The patient form defined by the XML file is generated. The form is displayed on a display.
... |
| Method for conducting double-blind testing using a constant amplitude electromagnetic system | 20070260136 | 20071108 |
| A method for performing a randomized double-blind medical clinical trial on a statistically significant number of participants using a constant amplitude electromagnetic system. The constant amplitude electromagnetic system comprises: a housing; at least one magnetic module contained within the housing, wherein each magnetic module includes: a ferromagnetic housing; including a non ferromagnetic segment forming an aperture; a wound magnetic wire coil on a perforated spindle having a coil diameter greater than a coil depth surrounding the aperture and located between the non-ferromagnetic segment and the ferromagnetic housing. The wound magnetic wire coil generates a constant amplitude electromagnetic magnetic field within the aperture when coupled to a direct electrical current.
... |
| Methods of treating diabetes | 20070253904 | 20071101 |
| The invention provides methods of screening for compounds that increase levels or activity of Aryl hydrocarbon Nuclear Receptor Translocator (ARNT) and/or Hypoxia Inducible Factor 1α (HIF1α), for the treatment and prevention of diabetes-related disorders, including type 1 and type 2 diabetes mellitus, impaired glucose tolerance, insulin resistance and beta cell dysfunction; compounds identified by said screening methods; and methods of using said compounds. Also included are methods for treating or preventing diabetes-related diseases using ARNT and/or HIF1α polypeptides and polynucleotides, and for using information regarding the expression, level or activity of ARNT and/or HIF1α in predictive medicine, e.g., diagnostic assays, prognostic assays, monitoring clinical trials, and pharmacogenetics.
... |
| Clinical trial finance management system | 20070255587 | 20071101 |
| A clinical trial finance management system is disclosed. It includes a clinical trial that can interact with clinical trial data associated with a clinical trial plan, and a financial management interface that can interact with financial data associated with the clinical trial plan. Relationship management logic is provided to interact with the clinical trial interface, to interact with the financial management interface, and to manage relationships between the clinical trial data and the financial data based on the clinical trial plan.
... |
| Prediction markets for assessing clinical probabilities of success | 20070250429 | 20071025 |
| Prediction markets are used to determine the probability of an experimental therapeutic, diagnostic, or prophylactic candidate meeting clinical trial and post-trial goals, such as clinical trial endpoints and timelines. The prediction market processes buy and sell orders from market participants, while adjusting the prices of the securities according to the orders. The securities have specific meanings which correspond to goals in clinical trials or other outcomes in clinical candidate development. The price of a security determined by the market corresponds to the probability of the corresponding goal or outcome. The participants are selected for their expert knowledge of specific factors related to candidate development. Using appropriately selected securities and participants, the prediction market may be used to generate probabilities of success useful for long-range planning and... |
| Method and system for providing real-time clinical trial enrollment data | 20070250779 | 20071025 |
| A method and system for enabling display of real-time clinical trial enrollment data. A set of computer forms corresponding to an application enable administrative personnel to define a plurality of clinical trial parameters, including trial protocols, clinical sites, and optional regions. As the data is entered, it is stored in a central database, typically through a dedicated connection between a client running the application and the database. Software and infrastructure for supporting an Internet web portal is also provided, whereby the web portal enables clinical site personnel to enter subject enrollment data that is stored in the database as it is entered (i.e., in real-time). Various charts pertaining to the subject enrollment data may then be generated, including subject status charts and subject enrollment rate charts.... |
| Method for distribution of configuration settings for medical devices | 20070250832 | 20071025 |
| A method is provided for configuring medical devices such as medical devices used in a clinical trial. Based on the needs of the clinical trial, a definition of a configuration of the medical devices to be used in the clinical trial is generated and the configuration data is transformed into a profile. The profile is distributed to sites at which the clinical trial will be conducted and the profile is applied to the medical devices at the sites to configure the medical devices. The medical devices are thereby capable of producing data that is comparable as between the sites used in the clinical trial.
... |
| Method of using online communities for effective clinical trial recruitment | 20070214012 | 20070913 |
| A method of recruiting clinical trial candidates using an online community is disclosed that includes creating an illness-specific online community. Membership accounts are created for members joining the online community. Personal and medical information is collected from the members and categorized and stored in a member database. Information on a clinical trial is collected from a client. The member database is searched to determine candidates for the clinical trial.
... |
| Enhancement of impaired motor and mental functions, using dextromethorphan and oxidase enzyme inhibitor | 20070191411 | 20070816 |
| During clinical trials on patients suffering from neurological disorders, it has been observed that some patients obtain dramatic improvements in motor control and/or higher mental functioning, when they receive a combination of dextromethorphan and quinidine, at suitable dosages. Improved motor control has been exemplified to date by improved ability to swallow and/or speak, among victims of stroke, head injury, or ALS. Improved higher mental functioning has been exemplified better job performance, increased ability to analyze and solve problems, and increased ability to have successful and satisfying interactions with other people. These types of effects can be seen in a relatively brief time period, such as within several days to a week.
... |
| Compositions and methods for enhancing nk cell activity | 20070178106 | 20070802 |
| The present invention relates to methods of treating malignancies and infections, methods of identifying patients suitable for treatment or for inclusion in clinical trials, and methods of producing antibodies for use in therapeutic applications. Generally, the present methods involve the use of antibodies that target activating receptors present on the surface of NK cells, and which at the same time interact with molecules present on the surface of malignant or infected target cells, thereby enhancing the therapeutic efficacy of the antibodies.
... |
| System and method for integrating and validating genotypic, phenotypic and medical information into a database according to a standardized ontology | 20070178501 | 20070802 |
| The system described herein enables clinicians and researchers to use aggregated genetic and phenotypic data from clinical trials and medical records to make the safest, most effective treatment decisions for each patient. This involves (i) the creation of a standardized ontology for genetic, phenotypic, clinical, pharmacokinetic, pharmacodynamic and other data sets, (ii) the creation of a translation engine to integrate heterogeneous data sets into a database using the standardized ontology, and (iii) the development of statistical methods to perform data validation and outcome prediction with the integrated data. The system is designed to interface with patient electronic medical records (EMRs) in hospitals and laboratories to extract a particular patient's relevant data. The system may also be used in the context of generating phenotypic predictions and enhanced... |
| Analyzing administrative healthcare claims data and other data sources | 20070174252 | 20070726 |
| Techniques suitable for identifying potential subjects for a clinical trial and other applications are disclosed. One or more exclusion or inclusion criteria are defined for the clinical trial. One or more specialized searching tables are pre-generated using administrative healthcare claims data and the one or more exclusion or inclusion criteria. The specialized searching tables are searched. Through the searching step, subjects are identified within the administrative healthcare claims data who match the one or more exclusion or inclusion criteria. Through the searching step, a geographical area is identified corresponding to the subjects who match the one or more exclusion or inclusion criteria. A customized report is generated using the identified subjects and geographical area.
... |
| In vitro cell-based methods for biological validation and pharmacological screening of chemical entities and biologicals | 20070166754 | 20070719 |
| This patent describes a novel in vitro cell-based method for biological validation and pharmacological screening of drugs, new chemical entities (NCEs) and biologics, which is predictive of in vivo testing for efficacy and adverse events in patients, as occurs in clinical trials. The same method can be used to create an in vitro cell-based assay to identify the ‘right marketed medication for the right patient’ (personalized medicine), and to identify responders and non-responders in ongoing clinical trials with NCEs.
... |
| Networked system for interactive communication and remote monitoring of pharmaceutical manufacturer and clinical trials | 20070168242 | 20070719 |
| A system for remotely monitoring an individual. The system includes a server system for generating a script program from a set of queries. The script program is executable by a remote apparatus that displays information and/or a set of queries to the individual through a user interface. Responses to the queries that are entered through the user interface together with individual identification information are sent from the remote apparatus to the server system across a communication network. The server system also includes an automated answering service for providing a series of questions from a stored set of questions for an individual at the remote apparatus to respond to, storing responses to each provided question in the series of questions and providing a service based on the... |
| System for conducting clinical trials | 20070156459 | 20070705 |
| There is disclosed a system (1) for conducting a clinical trial of a pharmaceutical substance on a plurality of trial participants. The system (1) includes a central database (2) having a memory means in communication with a database means, one or more trial sites each having a remote computer (3) located remotely from the central database (2) and in communication therewith, the central database (2) being configured to receive predetermined parameters of the trial, both the central database (2) and the remote computers (3) being configured to receive predetermined trial data from one or more trial participants, the central database (2) being configured to control and track the ordering, allocation and dispensing of the pharmaceutical substances and compiling a pharmaceutical substance inventory record on the central... |
| Method and process that automatically finds patients for clinical drug or device trials | 20070106531 | 20070510 |
| A method and system to rapidly and precisely identify patient candidates for clinical trials comprises a database component operative to maintain a hospital patient database component and its plurality of hospital databases and their corresponding plurality of patient names and medical records, in communication with one or more medical practice database components and their corresponding plurality of specialties and their corresponding plurality of patient names and medical records. The method and system also include a clinical studies database component and its corresponding plurality of clinical studies, a communications component to receive changes to said database component, and a processor programmed to periodically match compatible patients and clinical studies, and to generate reports to medical practices in said medical practice database having matched patients. The processor may... |
| Methods and systems for web based centralized patient assessment | 20070100663 | 20070503 |
| Assessment of clinical trial data collected at different clinical trial sites is centralized to reduce statistical variance in clinical trial data. Secure network locations for collection of clinical trial assessment data are connected with a central clinical data management server and associated database. The clinical trial assessment data received from different clinical trial sites are assessed centrally using the clinical data management server. In some embodiments, a remote clinician is enabled to cooperate with clinical trial subjects in the collection of clinical trial assessment data.
... |
| Clinical trial information processing system and method | 20070100885 | 20070503 |
| A system functioning between the clinical trial facility (trial site) and the party requesting clinical trial (sponsor) to make clinical trial more efficient. Information relating to the sponsor and information relating to the trial site, and trial basic information including the trial target disease name, the total length of trial (trial period), total number of cases and total budget registered by the sponsor, and trial contract conditions including the trial name, trial period, number of cases and budget are stored in a clinical trial database; and the process and information service unit distributes information on trial contract conditions registered in the contract information storage area to the trial site, registers applicant trial sites for trial relating to the distributed trial contract conditions, and distributes the status... |
| Identification of genetic components of drug response | 20070072232 | 20070329 |
| The present invention is concerned generally with the field of identifying an appropriate treatment regimen for a disease based upon genotype in mammals, particularly in humans. It is further concerned with the genetic basis of inter-patient variation in response to therapy, including drug therapy. Specifically, this invention describes the identification of gene sequence variances useful in the field of therapeutics for optimizing efficacy and safety of drug therapy. These variances may be useful during the drug development process and in guiding the optimal use of already approved compounds. DNA sequence variances in candidate genes (i.e., genes that may plausibly affect the action of a drug) are tested in clinical trials, leading to the establishment of diagnostic tests useful for improving the development of new pharmaceutical products... |
| Method and apparatus for screening, enrollment and management of patients in clinical trials | 20070067189 | 20070322 |
| A computer-implemented method of tracking patient data in a clinical trial is provided. The clinical trial has one or more investigative sites which perform patient screening and enrollment for the clinical trial, one or more diagnostic sites which perform analysis on one or more patient diagnostic tests ordered by an investigative site and generate analysis results, and a centralized data center in electronic communication with the one or more investigative sites and the one or more diagnostic sites. Each investigative site is provided with a user interface display screen for allowing a user at the investigative site to enter data regarding patients who have been screened for the clinical trial and patients who have been enrolled in the clinical trial. The data from each of the... |
| Compositions and methods for the diagnosis and treatment of immune disorders | 20070059303 | 20070315 |
| The present invention relates to methods and compositions for the treatment and diagnosis of immune disorders, especially T helper lymphocyte-related disorders. In particular, the invention describes a gene known in the art, alternatively, as ST2, T1 and Fit-1, and referred to herein as the 103 gene. The 103 gene is disclosed herein to be differentially expressed in TH2 cells and not in TH1 cells. Further, the 103 gene product is demonstrated herein to be an important modulator of TH2 and TH2-like immune response both in vitro and in vivo. Thus, the 103 gene, its gene products and antibodies that specifically bind thereto can be used diagnostically or as targets for therapeutic intervention in the treatment of a variety of immune disorders. In this regard, the invention... |
| Determining cancer-linked genes and therapeutic targets using molecular cytogenetic methods | 20070059697 | 20070315 |
| Methods for identifying potential therapeutic agents, such as anti-tumor agents, based on their modulation of the expression of specified genes, especially genes mapping to specific chromosomal regions, are disclosed. Also described are methods for diagnosing cancerous, or potentially cancerous, conditions as a result of the expression, or patterns of expression, of such genes, including detecting changes in levels of gene copy number and/or level of amplification of the said gene, or sets of genes, to detect and/or diagnose the cancer. Methods for detecting or determining functionally related genes, as well as methods for treating cancer based on targeting expression products of such genes, determining genes involved in the cancerous process and the success and/or response rates and survival statistics for cancer patients on treatment are encompassed... |
| Circulating tumor cells (ctc's): early assessment of time to progression, survival and response to therapy in metastatic cancer patients | 20070037173 | 20070215 |
| A cancer test having prognostic utility in predicting time to disease progression, overall survival, and response to therapy in patients with MBC based upon the presence and number of CTC's. The Cell Spotter® System is used to enumerate CTC's in blood. The system immunomagnetically concentrates epithelial cells, fluorescently labels the cells and identifies and quantifies CTC's. The absolute number of CTC's detected in the peripheral blood tumor load is, in part, a factor in prediction of survival, time to progression, and response to therapy. The mean time to survival of patients depended upon a threshold number of 5 CTC's per 7.5 ml of blood. Detection of CTC's in metastatic cancer represents a novel prognostic factor in patients with metastatic cancers, suggests a biological role for the... |
| Systems and methods for managing clinical trials | 20070038472 | 20070215 |
| Improved clinical trial methods including the use of subject monitors operating separately from standard clinical trial facilities and/or protocols. The subject monitors may independently or separately contact individual subjects to reinforce trial protocols, and observe compliance levels. Databases may be built and maintained for providing indications of the quality of a clinical trial. Clinical trial materials may be provided via the use of the independently operating subject monitors.
... |
| Dynamic healthcare modeling | 20070038475 | 20070215 |
| A method for simulating a clinical trial includes: selecting a trial procedure for a simulated trial corresponding to the clinical trial; generating a population of subjects for the simulated trial; searching the population of subjects to determine acceptable subjects for the simulated trial; selecting subjects for the simulated trial from the acceptable subjects; simulating the trial procedure for the selected subjects; and collecting trial data for the simulated trial from the simulated trial procedure.
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| Defining virtual patient populations | 20070026365 | 20070201 |
| The invention encompasses methods, including computer-implemented methods, of defining a virtual patient population and mapping the virtual patient population to a population of real patients. The invention utilizes virtual measures from one or more virtual patients, and data representative of multiple real subjects in a sample population, such as data collected from patients in a clinical trial or epidemiological study of a real population. The invention includes evaluating the similarity between the virtual patients and the real subjects, and assigning prevalences to the virtual patients based on the evaluation. The similarity can be assessed using some or all of the virtual measures of the virtual patients and some or all of the data obtained for the real subjects. Any of various goodness-of-fit measures can be used... |
| Method and system for modeling scenarios in clinical trials | 20060282244 | 20061214 |
| A computer-based method for modeling scenarios for clinical trials in a drug development process is disclosed. The method provides study data to a computer system where the study data represents data from one or more studies on patients performed during the clinical trials of the drug. The method displays on a display device of the computer system the study data for one or more studies and displays scenarios on the display device where the scenarios represent changes to be made to the one or more studies to model the effect of the changes on the clinical trials. The system allows changing one or more of the parameters for the one or more studies using the scenarios displayed to model the effect of the changes on the... |
| Methylene blue therapy of viral disease | 20060264423 | 20061123 |
| A method for using thiazine dyes, especially methylene blue or methylene blue derivatives, in an immediate or controlled release formulation, alone or in combination with low levels of light or other drugs, to selectively inactivate or inhibit hepatitis infection, has been developed. Clinical trial results demonstrate efficacy in a human clinical trial for treatment of hepatitis C by oral administration of methylene blue immediate release formulation, in a dosage of 65 mg twice daily, over a period of at least 100 days. A method for using thiazine dyes, especially methylene blue or methylene blue derivatives, in an immediate or controlled release formulation, along or in combination with low levels of light or other drugs, to prevent or decrease reactivation of viruses, is also described. The preferred... |
| Methods and systems for clinical trial data management | 20060259783 | 20061116 |
| The invention provides systems and methods for creating certified copies of original information, including original hardcopy documents, in compliance with federal regulations and guidelines. The present invention also provides systems and methods of data management, and in particular, management of such certified copies. In some embodiments the invention relates to original clinical trial information such as source documents, and methods and systems for creating certified copies of such information to create an accessible central repository of such certified copies.
... |
| Integrated data collection and analysis for clinical study | 20060224326 | 20061005 |
| A data collection system includes remote, implantable sensors for monitoring one or more patient parameters, collecting and processing data from those sensors and utilizing that data in the performance of a clinical study of a drug or other pharmacological agent. The system assists with preparation of a protocol for a clinical trial; presentation of that protocol; assuring compliance with the protocol; and generating useful results from data collected via the system and externally for presentation to an approval forum.
... |
| Integrated data collection and analysis for clinical study | 20060224421 | 20061005 |
| A data collection system includes remote, implantable sensors for monitoring one or more patient parameters, collecting and processing data from those sensors and utilizing that data in the performance of a clinical study of a drug or other pharmacological agent. The system assists with preparation of a protocol for a clinical trial; presentation of that protocol; assuring compliance with the protocol; and generating useful results from data collected via the system and externally for presentation to an approval forum.
... |
| Methods and systems for predicting cancer outcome | 20060195269 | 20060831 |
| The invention provides a molecular marker set that can be used for prognosis of colorectal cancer in a colorectal cancer patient. The invention also provides methods and computer systems for evaluating prognosis of colorectal cancer in a colorectal cancer patient based on the molecular marker set. The invention also provides methods and computer systems for determining chemotherapy for a colorectal cancer patient and for enrolling patients in clinical trials.
... |
| Apparatus and method for prediction and management of participant compliance in clinical research | 20060184493 | 20060817 |
| A system for developing and implementing empirically derived algorithms to generate decision rules to determine participant noncompliance and fraud with research protocols in clinical trials allows for the identification of complex patterns of variables that detect or predict participant noncompliance and fraud with research protocol, including performance and enrollment goals, in the clinical trial. The data may be used to overall predict the performance of any participant in a clinical trial, allowing selection of participants that tend to produce useful, high-quality results. The present invention can also be used to monitor participant compliance with the research protocol and goals to determine preferred actions to be performed. Optionally, the invention may provide a spectrum of noncompliance, from minor noncompliance needing only corrective feedback, to significant noncompliance requiring... |
| Clinical development plan, facility development plan and process development plan knowledge bases | 20060178906 | 20060810 |
| Exemplary embodiments of the present invention provide three knowledge bases: (1) a clinical development plan (CDP) knowledge base for development of a molecular or cellular Phase I or II clinical trial; (2) a facility development plan (FDP) knowledge base for the economic and functional setup of translational laboratory, clean room production and cell handling facilities including the processes of planning, constructing and validating a facility for GCP testing and GMP manufacturing of products to support molecular and gene therapy clinical trials; and (3) a process development plan (PDP) knowledge base for development of manufacturing and analytic processes in support of Phase I or II clinical trials. The present invention also provides systems and methods associated with such knowledge bases.
... |
| Research protocol toolkit | 20060179418 | 20060810 |
| Exemplary embodiments of the present invention comprise a tool kit for the design and execution of research protocols, for example, comprising a web-based research protocol composer for generating a data processing protocol; a collector for collecting data entered via an internet based questionnaire; a database for data; and a protocol processing routine for processing data and generating an output. For example, the toolkit suitably serves as a “hub” of a global research environment (e.g., connected via the Internet or other network) that creates and connects communities of researchers and facilitates the sharing of software and results. Additionally, the present invention provides standardized and custom online “programs” or “scripts” (referred to herein as “protocols”) that define and guide events in experiments, clinical trials, surveys, and other kinds... |
| System and method for configuring electronic data capture and data management systems for clinical trials | 20060174210 | 20060803 |
| The present invention includes aspects of a designer program or tool for customizing a clinical trial program to a particular protocol of a particular clinical trial. The designer program includes visual cues or mechanisms for organizing trial components within the designer program in a straightforward manner such that technically low skilled designers can implement often complex trial protocols. In an embodiment, the designer program includes validation scripts that test functions, derivations, queries and the like. Moreover, use of the designer program can include development of trial libraries that can make customizations reusable, scalable, and highly efficient.
... |
| Methods and systems for online clinical trial screening | 20060149602 | 20060706 |
| In a clinical trial program screening method, potential clinical trial candidates are driven to a screening website by, for example, banner ads, text messages, or other electronic advertisements. When a respondent clicks the advertisement, a multiple level screening method is conducted to screen qualified candidates for participation in a clinical trial program. Diagnostic, demographic and/or geographic data are collected from respondents and used to screen for predetermined clinical trial participation criteria. The effectiveness of the recruitment method is periodically evaluated and optimized to realize maximal recruitment efficiency.
... |
| Differential gene expression in schizophrenia | 20060150264 | 20060706 |
| The invention relates to methods of identifying potential therapeutic agents for the prevention, treatment, or amelioration of schizophrenia, to methods of diagnosis of schizophrenia, to methods of identifying patients most likely to respond to a particular therapeutic treatment, to methods for selecting participants in clinical trials, and to methods of prevention, treatment, or amelioration of schizophrenia.
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| Clinical trial management system | 20060143047 | 20060629 |
| A system for designing and monitoring clinical trials includes a main database of information concerning prior clinical trials and resources available to conduct future clinical trials. In part information in the main database is obtained through data links to other databases in the enterprise, e.g., human resources and finance databases. Some of the information in the main database concerns prior clinical trials and is, in part, in the form of a protocol of (a) scheduled visits of a test subject to a treatment site, (b) measurement of prescribed physical attributes of the subject during the visits and (c) administration of at least one prescribed medical product to the subject during the visit to determine over time the subject's response thereto. The protocols of prior clinical trial... |
| System for continuous outcome prediction during a clinical trial | 20060129326 | 20060615 |
| The present invention provides a method, apparatus, and computer instructions for improved control of clinical trials. In a preferred embodiment, after a clinical trial is initiated, data is regularly cleaned and processed to statistically analyze the data. The outcome includes a predictive measure of the timing and level by which the study will achieve one or more statistically significant levels, allowing mid-course modifications to the study (e.g., in population size, termination, etc.). Modification can be planned as part of the initial protocol, using thresholds or other appropriate criteria relating to the statistical outcome, making possible pre-approved protocol changes based on the statistical findings. This process has significant implications for the management of clinical studies, including ensuring the minimum possible time and number of patients are used... |
| Pharmaceutical proteins, human therapeutics, human serum albumin insulin, native cholera toxic b submitted on transgenic plastids | 20060117412 | 20060601 |
| Mass production of affordable vaccines can be achieved by genetically engineering plants to produce recombinant proteins that are candidate vaccine antigens. The B subunits of Enteroxigenic E. coli (LTB) and cholera toxin of Vibrio cholerae (CTB) are examples of such antigens. When the native LTB gene was expressed via the tobacco nuclear genome, LTB accumulated at levels less than 0.01% of the total soluble leaf protein. Production of effective levels of LTB in plants, required extensive codon modification. Amplification of an unmodified CTB coding sequence in chloroplasts, up to 10,000 copies per cell, resulted in the accumulation of up to 4.1% of total soluble tobacco leaf protein as oligomers (about 410 fold higher expression levels than that of the unmodified LTB gene). PCR and Southern blot... |
| Apparatus and methods for monitoring subjects | 20060084848 | 20060420 |
| This invention provides a device, and method and system for its use, for monitoring participants in clinical trials so that participant self-reporting, which is known to be notoriously inaccurate, can be minimized or eliminated. In preferred embodiments, the device is self-contained and self-powered, resides on or in a body cavity of the participant, collects data monitoring medically relevant aspects of the participant's behavior and of the local device environment, and stores data in a memory on-board the device. An accompanying external station reads stored data and prepares it for use. Devices may include electrically-active sensors and non-electrical active sampling sensors. A preferred embodiment of the device is in clinical trials of microbicides inhibiting transmission of the HIV virus.
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| Unit dose compliance monitoring & reporting device & system | 20060079996 | 20060413 |
| A unit dose medication compliance monitoring and reporting apparatus and system that includes a dispenser shell formed with dose compartments. A retainer sheet affixed to the shell seals each compartment and partially bursts upon dispensing. A sensor network and monitoring and reporting circuitry records dispensing times and determines an average time interval, which can be reported with other data on an integral data display. The system can thereby monitor and report patient compliance with prescription regimens. Additional data can be recorded and displayed for augmented patient compliance assistance and analysis, which data can include customized informational messages, telephone and other patient support contact information, unit doses dispensed and remaining, reminder alarms, identification data, prescription regimens, among other data. In myriad variations and alternative preferred configurations, the... |
