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Screen failure data in clinical trials: Are screening logs worth it?
Jordan J Elm1, Yuko Palesch2, J Donald Easton3
1Department of Public Health Sciences, Medical University of South Carolina, Charleston, SC, USA elmj@musc.edu.
Clinical Trials (London, England)
|June 14, 2014
Summary
Collecting clinical trial screening data from non-enrolled patients is costly and often lacks scientific value. Standardizing this data collection across multicenter trials presents significant challenges, questioning its overall justification.
Area of Science:
- Clinical trial methodology
- Health services research
Background:
- Clinical trials often collect data on screened patients who are not enrolled.
- Consolidated Standards of Reporting Trials (CONSORT) guidelines support collecting screening data for scientific, management, and socio-cultural reasons.
Purpose of the Study:
- To evaluate the justification for the cost of collecting clinical trial screening data.
- To highlight challenges in centrally monitoring and verifying screening data compared to other clinical trial data.
Main Methods:
- Analysis of screening data from the multicenter Platelet-Oriented Inhibition in New Transient Ischemic Attack and Minor Ischemic Stroke (POINT) trial.
- Examination of data from over 27,000 screened patients across 172 sites.
Main Results:
- High return rate (95%) of screen failure logs, but 23% reported 'no data' due to administrative issues.
- Significant site-to-site variability in data collection processes.
- Majority of screened patients (95%) were not enrolled in the trial.
Conclusions:
- Standardizing screening data collection in multicenter trials is challenging due to varying site processes.
- The effort for high-quality central data collection may exceed scientific value.
- Lack of standardized definitions and consent issues limit data comparability and generalizability assessment.
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