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Nicholas J. DeVito

University of Oxford
Co-Authors: Ben Goldacre

Abstract: Compliance with Clinical Trials Reporting Requirements of the FDA Amendments Act 2007

Background:
The FDA Amendments Act of 2007, and subsequent Final Rule, require the registration and reporting of certain trials on ClinicalTrials.gov.
Method:
Requirements of the Final Rule were reviewed for aspects where compliance can be assessed using quantitative methods. Compliance is assessed on: reporting summary results; the quality control process; certificates of delay; protocol sharing; and study results being updated results at study completion. Data was extracted from ClinicalTrials.gov archives collected via the TrialsTracker project. Descriptive and regression analysis was conducted.
Results:
This study is in final analysis. Findings will be presented at the meeting.
Conclusion:
Legal requirements to report results rely on clear implementation and enforcement. This poster will examine and scrutinize various aspects of the Final Rule to determine where attention is needed to realize the advances to reporting envisioned by the law.

Poster: Compliance with Clinical Trials Reporting Requirements of the FDA Amendments Act 2007