“Hardly worth the effort”? Medical journals’ policies and their editors’ and publishers’ views on trial registration and publication bias: quantitative and qualitative studyBMJ 2013; 347 doi: https://doi.org/10.1136/bmj.f5248 (Published 06 September 2013) Cite this as: BMJ 2013;347:f5248
- Elizabeth Wager, publications consultant1,
- Peter Williams, research associate2
- on behalf of the OPEN Project (Overcome failure to Publish nEgative fiNdings) Consortium
- Correspondence to: E Wager
- Accepted 12 August 2013
Objectives To determine the proportion of medical journals requiring trial registration and to understand their reasons for adopting (or not adopting) such policies and other measures designed to reduce publication bias.
Design Quantitative study of journals’ instructions to authors (in June 2012) and qualitative study of editors’ and publishers’ views on trial registration and publication bias (carried out in Autumn 2012).
Setting Random selection of 200 medical journals publishing clinical trials identified from the Cochrane CENTRAL database.
Participants Editors (n=13) and publishers (n=3) of journals with different policies on trial registration (and with recently changed policies) identified from the survey of their instructions to authors.
Results Only 55/200 journals (28%) required trial registration according to their instructions and a further three (2%) encouraged it. The editors and publishers interviewed explained their journals’ reluctance to require registration in terms of not wanting to lose out to rival journals, not wanting to reject otherwise sound articles or submissions from developing countries, and perceptions that such policies were not relevant to all journals. Some interviewees considered that registration was unnecessary for small or exploratory studies.
Conclusions Although many major medical journals state that they will only publish clinical trials that have been prospectively registered, and such policies have been associated with a dramatic increase in the number of trials being registered, most smaller journals have not adopted such policies. Editors and publishers may be reluctant to require registration because they do not understand its benefits or because they fear that adopting such a policy would put their journal at a disadvantage to competitors.
We thank the editors and publishers who agreed to be interviewed and Sally Hopewell and Iveta Simera for suggestions about using the Cochrane CENTRAL database for this study.
Contributors: EW designed the study, obtained the funding, carried out the quantitative survey of journal instructions to authors, drafted sections of the paper, revised the whole paper, and is the study guarantor. PW contributed to the development of the interview schedule, performed all the interviews, analysed the qualitative findings, drafted sections of the paper, and revised the whole paper.
Funding: This study was part of the OPEN project (Overcome failure to Publish nEgative fiNdings, www.open-project.eu/) which was funded from the European Union Seventh Framework Programme (FP7-HEALTH.2011.4.1-2) under grant agreement No 285453. The funder had no role in any part of the research.
Competing interests: All authors have completed the ICMJE uniform disclosure form at www.icmje.org/coi_disclosure.pdf (available on request from the corresponding author) and declare: EW and PW had support from the European Union for the submitted work; they have no financial relationships with any organisations that might have an interest in the submitted work in the previous three years; EW is a member of the advisory board of the International Standard Randomised Controlled Trial Number (ISRCTN) scheme, this is an unpaid position; she was also a member of the World Health Organization Scientific Advisory Group on trial registration (2005-07) and received expenses to attend occasional meetings; she acts as a paid consultant to several journal publishers.
Ethical approval: Research ethical approval was waived by the UCL research ethics committee.
Data sharing: In line with the OPEN project’s publication policy, data from the quantitative part of this study are available in the supplementary tables. Anonymised versions of the qualitative data (interview transcripts) may be shared with other researchers on a case by case basis, but only if the anonymity of the interviewees can be assured.
Members of the OPEN project Consortium are listed at www.open-project.eu/project-partner.
This is an Open Access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 3.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/3.0/.