Apparatus and method for prediction and management of subject compliance in clinical research
US6879970B2 · kind B2 · utility
Assignee
Inventors
Key dates
| Filing date | Apr 2, 2001 |
| Grant date | Apr 12, 2005 |
| Priority date | — |
| Expiry date | Sep 16, 2023 |
Classification
- Technology area (CPC G)Physics
- CPC primaryG16Z99/00
- WIPO fieldMedical technology
- WIPO sectorInstruments
Abstract
A system for developing and implementing empirically derived algorithms to generate decision rules to predict subject noncompliance and fraud with research protocols in clinical trials allows for the identification of complex patterns of variables that detect or predict subject noncompliance and fraud with research protocol in the clinical trial. The present invention can also be used to monitor subject compliance with the research protocol 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 subject removal from the clinical trial. 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 or age which provides for algorithms and decision rules to be optimized for the specific sample of subjects being studied.
Source: USPTO / EPO open patent data. Objective bibliographic and citation counts.