Promoting public access to clinical trial protocols: Challenges and recommendations

An Wen Chan*, Asbjørn Hróbjartsson

*Corresponding author for this work

Research output: Contribution to journalComment/debateResearchpeer-review

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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.

Original languageEnglish
Article number116
JournalTrials
Volume19
Number of pages7
ISSN1745-6215
DOIs
Publication statusPublished - 17. Feb 2018

Keywords

  • Clinical trial protocol
  • Publication
  • Selective reporting
  • Transparency
  • Humans
  • Access to Information
  • Clinical Trial Protocols as Topic
  • Periodicals as Topic
  • Information Dissemination

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