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Published in: Trials 1/2017

Open Access 01-12-2017 | Commentary

Publishing protocols for trials of complex interventions before trial completion – potential pitfalls, solutions and the need for public debate

Authors: Anna Purna Basu, Janice Elizabeth Pearse, Tim Rapley

Published in: Trials | Issue 1/2017

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Abstract

Background

Open Science is ‘the movement to make scientific research, data and dissemination accessible to all levels of an inquiring society’.
In the spirit of the Open Science movement, advance publication of protocols for clinical trials is now being advocated by BioMed Central, BMJ Open and others. Simultaneously, participants are becoming increasingly active in their pursuit and sharing of trial- and health- related information. Whilst access to protocols alongside published trial findings has clear benefits, advance publication of trial protocols is potentially problematic for trials of complex behavioural interventions. In this article we explain, with examples, how this could lead to unblinding, ‘contamination’ between intervention and control groups and deliberate biasing of assessment outcomes by participants. We discuss potential solutions and demonstrate the need for public debate about how this issue is best managed.

Conclusion

Triallists may still be underestimating participants’ interest in information. This needs to change: joint and open discussions with the public are needed to inform how we should proceed.
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Metadata
Title
Publishing protocols for trials of complex interventions before trial completion – potential pitfalls, solutions and the need for public debate
Authors
Anna Purna Basu
Janice Elizabeth Pearse
Tim Rapley
Publication date
01-12-2017
Publisher
BioMed Central
Published in
Trials / Issue 1/2017
Electronic ISSN: 1745-6215
DOI
https://doi.org/10.1186/s13063-016-1757-7

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