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. 2018 Feb 17;19(1):116.
doi: 10.1186/s13063-018-2510-1.

Promoting public access to clinical trial protocols: challenges and recommendations

An-Wen Chan  1   2 , Asbjørn Hróbjartsson  3   4
Affiliations

Promoting public access to clinical trial protocols: challenges and recommendations

An-Wen Chan et al. Trials. .

Abstract

Background: Recognizing the value of promoting public access to clinical trial protocols, Trials pioneered the way for their publication over a decade ago. However, despite major advances in the public accessibility of information about trial methods and results, protocol sharing remains relatively rare.

Main body: Protocol sharing facilitates the critical appraisal of clinical trials and helps to identify and deter the selective reporting of outcomes and analyses. Challenges to the routine availability of high quality trial protocols include the gaps in incentives and adherence mechanisms, limited venues for sharing the original and final protocol versions, and the need for mechanisms to ensure transparent and complete protocol content.

Conclusions: We propose recommendations for addressing key challenges to protocol sharing in order to promote routine public access to protocols for the benefit of patients and other users of evidence from clinical trials.

Keywords: Clinical trial protocol; Publication; Selective reporting; Transparency.

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Conflict of interest statement

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Not applicable.

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Not applicable.

Competing interests

The authors declare that they have no competing interests.

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