Promoting public access to clinical trial protocols: challenges and recommendations
Open accessAbstract
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.
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Adherence to SPIRIT 2025 may help ensure that protocols contain the requisite information for critical appraisal and trial interpretation by peer reviewers, funders, REC/IRBs, and journals.
“Further, adherence to SPIRIT 2025 may help ensure that protocols contain the requisite information for critical appraisal and trial interpretation by peer reviewers, funders, REC/IRBs, and journals.7”
From SPIRIT 2025 statement: updated guideline for protocols of randomised trials (2025) · cites this paper as [7]
Such bias can only be identified and deterred if trial outcomes are clearly defined a priori in the protocol, and if protocol information is made public.
“Such bias can only be identified and deterred if trial outcomes are clearly defined a priori in the protocol, and if protocol information is made public.78 260 261 262”
From SPIRIT 2025 explanation and elaboration: updated guideline for protocols of randomised trials (2025) · cites this paper as [78]
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References 73 · Cited by 84
Research works printed but not linked: 3
- [13]European Commission. Guidance on posting and publication of result-related information on clinical trials in relation to the implementation of Article 57(2) of Regulation (EC) No 726/2004 and Article 41(2) of Regulation (EC) No 1901/2006. Official Journal of the European Union. 2012. https://ec.europa.eu/health/files/eudralex/vol-10/2012_302-03/2012_302-03_en.pdf. Accessed 12 Feb 2018.
- [55]PLOS Medicine. Submission Guidelines. 2017. http://journals.plos.org/plosmedicine/s/submission-guidelines. Accessed 2 Jan 2018.
- [56]Annals of Internal Medicine. Information for Authors. 2018. http://annals.org/aim/pages/authors. Accessed 2 Jan 2018.
- Authors
- Chan, A.-W., & Hróbjartsson, A.
- Affiliations
- University of Toronto (CA)
- University of Southern Denmark (DK)
- Corresponding author
- Chan, An-Wen
- Venue
- Trials
- Published
- 2018-02-17
- Volume
- 19
- Issue
- 1
- Pages
- 116-116
- ISSN
- 1745-6215 (ISSN-L)
- PMC
- PMC5816550
- OpenAlex
- W2800301195
- Cited by
- 84
- References
- 73
- Citations by year
- 2026: 8 · 2025: 16 · 2024: 8 · 2023: 6 · 2022: 13 · 2021: 9 · 2020: 14 · 2019: 7 · 2018: 3
- FWCI
- 11.69
- Type
- journal article
- Language
- en
- Open access
- gold
- doi.org
- Licence
- cc-by
- Locations
- Trials (publishedVersion, cc-by)
- PubMed Central (publishedVersion, cc-by)
- PubMed (publishedVersion)
- University of Southern Denmark Research Portal (University of Southern Denmark) (publishedVersion, cc-by)
- TSpace (University of Toronto) (submittedVersion, cc-by)
- DOAJ (DOAJ: Directory of Open Access Journals) (submittedVersion, cc-by-sa)
- Topics
- Social Sciences › Decision Sciences › Information Systems and Management › Academic Publishing and Open Access
- Social Sciences › Decision Sciences › Statistics, Probability and Uncertainty › Meta-analysis and systematic reviews
- Physical Sciences › Computer Science › Information Systems › Research Data Management Practices
- Keywords
- public access to research, protocol sharing, selective reporting, critical appraisal, transparency, access to evidence
- MeSH terms
- Clinical Trial Protocols as Topic, Humans, Periodicals as Topic, Access to Information, Information Dissemination
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