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A web-based endpoint adjudication system for interim analyses in clinical trials.
Tracy L Nolen1, Bill F Dimmick, Luis Ostrosky-Zeichner
1Rho Federal Systems Division, Inc, Chapel Hill, NC 27517, USA. tlrobin4@yahoo.com.
Clinical Trials (London, England)
|March 4, 2009
Summary
A new web-based system streamlines clinical trial endpoint adjudication, ensuring timely and accurate data for interim analyses. This efficient process supports data monitoring committees and enhances trial integrity.
Area of Science:
- Clinical trial methodology
- Data management in research
- Biostatistics and epidemiology
Background:
- Data Monitoring Committees (DMCs) require complete and verified data for interim analyses.
- Subjective endpoints and clinical expertise complicate data verification for DMCs.
- Existing methods for handling adjudicated data have significant inadequacies.
Purpose of the Study:
- To develop an efficient process for endpoint adjudication in a clinical trial for invasive candidiasis prophylaxis.
- To ensure adjudicated endpoints were available for interim analyses as required by the sponsor.
- To address the need for timely data verification with subjective or complex endpoints.
Main Methods:
- A web-based endpoint adjudication system (WebEAS) was developed for expedited review.
- The system automates subject data completeness checks, profile creation, and reviewer assignment.
- WebEAS facilitates reviewer submission, comparison, tie-breaking, and data storage.
Main Results:
- The WebEAS system was implemented and found to be user-friendly and navigable after initial accessibility issues were resolved.
- The system successfully facilitated the adjudication process for the clinical trial.
- Despite a small sample size (38 subjects) and early administrative closure, the adjudication process was completed.
Conclusions:
- Web-based data adjudication is effective when supported by prompt data collection and verification.
- The automated WebEAS offers a practical solution for timely endpoint adjudication in clinical trials.
- Future endpoint adjudication committees should consider both clinical expertise and web-based technology proficiency.
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