Healthy Skepticism Library item: 4180
Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.
Publication type: Journal Article
Easterbrook PJ, Berlin JA, Gopalan R, Matthews DR.
Publication bias in clinical research.
Lancet 1991 Apr 13; 337:(8746):867-72
Abstract:
(Limited to parts of article dealing with promotion.) Out of 73 unpublished studies, the sponsoring pharmaceutical companies were blamed for nonpublication in 11%, since they managed the data and were therefore considered responsible for initiating publication. However, 10 of these studies were reportedly conducted solely for the purpose of a product licence application and were not intended for publication.
In a retrospective survey, 487 research projects approved by the Central Oxford Research Ethics Committee between 1984 and 1987, were studied for evidence of publication bias. As of May, 1990, 285 of the studies had been analysed by the investigators, and 52% of these had been published. Studies with statistically significant results were more likely to be published than those finding no difference between the study groups (adjusted odds ratio [OR] 2.32; 95% confidence interval [Cl] 1.25-4.28). Studies with significant results were also more likely to lead to a greater number of publications and presentations and to be published in journals with a high citation impact factor. An increased likelihood of publication was also associated with a high rating by the investigator of the importance of the study results, and with increasing sample size. The tendency towards publication bias was greater with observational and laboratory-based experimental studies (OR = 3.79; 95% Cl = 1.47-9.76) than with randomised clinical trials (OR = 0.84; 95% Cl = 0.34-2.09). We have confirmed the presence of publication bias in a cohort of clinical research studies. These findings suggest that conclusions based only on a review of published data should be interpreted cautiously, especially for observational studies. Improved strategies are needed to identify the results of unpublished as well as published studies.
Keywords:
*analytic survey/United Kingdom/drug company sponsored research/publication bias/SPONSORSHIP: RESEARCH
Bias (Epidemiology)*
Biomedical Research*
Clinical Trials
Cohort Studies
Confidence Intervals
Data Collection
Editorial Policies*
Ethical Review
Ethics Committees, Research
Information Dissemination*
Odds Ratio
Periodicals/statistics & numerical data
Publishing/statistics & numerical data*
Randomized Controlled Trials
Research/statistics & numerical data*
Research Design
Research Support, Non-U.S. Gov't
Retrospective Studies
