25 Apr Submission and Publication Bias Against Studies With Negative Results Declining
MedicalResearch.com Interview with:
Gary Evoniuk, PhD
Director of Publication Practices, Medical Communications Quality & Practices
GlaxoSmithKline Research and Development, Research Triangle Park, NC 27709
MedicalResearch.com: What is the background for this study?
Response: In recent years, industry, and to a lesser extent academia, have been criticised for failing to submit clinical trial data for publication, especially when the data are perceived to be “negative”, (i.e. unfavourable to the drug under study) leading to publication bias. We felt it was important to determine whether this criticism is based on perception or reality and so we conducted what is, to our knowledge the only study to systematically address the issue of submission and publication bias based on study outcome.
MedicalResearch.com: What are the main findings?
Response: Results showed no evidence of submission bias (by GSK) or publication bias (by journals) against “negative” study results. Submission and publication rates for negative studies were, if anything, higher than for positive studies (submission rates by study outcome were “Positive” 79% vs. “Negative” 92%; publication rates were 66% vs. 77%. However, first-time journal acceptance rates were higher for positive studies (56% vs. 48%) and over 10% of studies across all categories required 3 or more submissions to achieve successful publication.
MedicalResearch.com: What should readers take away from your report?
Response: Submission and publication bias against studies with negative outcomes appears to be less widespread than has generally been assumed and should not deter efforts to publish negative studies. Sponsors need to recognize that it may take multiple attempts to publish and readers need to recognize that, until now, estimated publication rates that have appeared in literature reviews have failed to take into account sponsors’ unsuccessful attempts to publish.
MedicalResearch.com: What recommendations do you have for future research as a result of this study?
Response: We encourage other sponsors and journal editors to share similar information on submission and publication rates in an effort to contribute to better understanding of issues and barriers to full transparency.
All author disclosures appear in the version published by BMJ.
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Impact of study outcome on submission and acceptance metrics for peer reviewed medical journals: six year retrospective review of all completed GlaxoSmithKline human drug research studies
BMJ 2017; 357 doi: https://doi.org/10.1136/bmj.j1726 (Published 21 April 2017)Cite this as: BMJ 2017;357:j1726
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Last Updated on April 25, 2017 by Marie Benz MD FAAD