Promoting public access to clinical trial protocols

Challenges and recommendations

An Wen Chan*, Asbjørn Hróbjartsson

*Kontaktforfatter for dette arbejde

Publikation: Bidrag til tidsskriftKommentar/debatForskningpeer review

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Resumé

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.

OriginalsprogEngelsk
Artikelnummer116
TidsskriftTrials
Vol/bind19
Antal sider7
ISSN1745-6215
DOI
StatusUdgivet - 17. feb. 2018

Fingeraftryk

Clinical Trials
Publications

Citer dette

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Promoting public access to clinical trial protocols : Challenges and recommendations. / Chan, An Wen; Hróbjartsson, Asbjørn.

I: Trials, Bind 19, 116, 17.02.2018.

Publikation: Bidrag til tidsskriftKommentar/debatForskningpeer review

TY - JOUR

T1 - Promoting public access to clinical trial protocols

T2 - Challenges and recommendations

AU - Chan, An Wen

AU - Hróbjartsson, Asbjørn

PY - 2018/2/17

Y1 - 2018/2/17

N2 - 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.

AB - 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.

KW - Clinical trial protocol

KW - Publication

KW - Selective reporting

KW - Transparency

KW - Humans

KW - Access to Information

KW - Clinical Trial Protocols as Topic

KW - Periodicals as Topic

KW - Information Dissemination

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M3 - Comment/debate

VL - 19

JO - Trials

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