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Promoting public access to clinical trial protocols: challenges and recommendations
An-Wen Chan1,2, Asbjørn Hróbjartsson3,4
1Women's College Research Institute, Women's College Hospital, 76 Grenville St, Rm 6416, Toronto, ON, M5S 1B2, Canada. anwen.chan@utoronto.ca.
Trials
|February 19, 2018
Summary
Public access to clinical trial protocols is crucial but rare. Recommendations are proposed to overcome challenges and improve protocol sharing for patient benefit.
Area of Science:
- Clinical Trials
- Medical Research Transparency
- Evidence-Based Medicine
Background:
- Promoting public access to clinical trial protocols is vital for research integrity.
- Despite advances in trial results accessibility, protocol sharing remains limited.
- Trials journal has advocated for protocol publication for over a decade.
Discussion:
- Protocol sharing enhances critical appraisal of clinical trials.
- It aids in identifying and preventing selective reporting of outcomes and analyses.
- Barriers include lack of incentives, adherence mechanisms, and limited sharing venues.
Key Insights:
- Addressing gaps in incentives and adherence is necessary for routine protocol availability.
- Establishing transparent mechanisms for sharing original and final protocol versions is essential.
- Ensuring complete and transparent protocol content is a key challenge.
Outlook:
- Proposed recommendations aim to overcome challenges to protocol sharing.
- The goal is to promote routine public access to clinical trial protocols.
- This will benefit patients and users of evidence from clinical trials.
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