Apparatus and method for prediction and management of participant compliance in clinical research
First Claim
1. A method of determining noncompliance of a participant in a clinical trial, comprising the steps of:
- providing historical participant compliance data; and
generating at least one algorithm for determining participant noncompliance by quantitative analysis of the historical participant compliance data.
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Accused Products
Abstract
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 participant removal from the clinical trial or from future clinical trials. The algorithms and decision rules can also be domain-specific, such as detecting non-compliance or fraud among subjects in a cardiovascular drug trial, or demographically specific, such as taking into account gender, age or location, which provides for algorithms and decision rules to be optimized for the specific sample of participants being studied.
112 Citations
30 Claims
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1. A method of determining noncompliance of a participant in a clinical trial, comprising the steps of:
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providing historical participant compliance data; and
generating at least one algorithm for determining participant noncompliance by quantitative analysis of the historical participant compliance data. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 13, 14, 15, 30)
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12. The method of claim 11, wherein at least one algorithm for determining participant noncompliance by quantitative analysis of the historical participant compliance data is generated for each participant.
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12-1. (canceled)
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16. A method of identifying a suitable clinical trial site for conducting a clinical trial, comprising the steps of:
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providing a database storing historical compliance data for a plurality of clinical trial sites;
performing a statistical analysis of the historical compliance data for each clinical trial site to predict compliance in a future clinical trial; and
selecting a clinical trial site that is predicted to comply with research protocols. - View Dependent Claims (17, 18, 19, 20, 21, 22)
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23. A method of predicting success of a clinical trial involving a selected clinical trial participant, comprising the steps of:
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providing historical compliance data from a clinical trial involving the clinical trial participant; and
performing a quantitative analysis of the data to identify whether the participant is likely to produce data in compliance with research protocol in the future. - View Dependent Claims (24, 25, 26, 27, 28, 29)
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Specification