What You See Depends on Where You’re Looking and How You Look at It: Publication Bias and Outcome Reporting Bias
Abstract
Study publication bias is the decision to publish or not publish a study based on its results. Compared to unpublished work, published studies are more likely to have positive or statistically significant findings. Outcome reporting bias is opting to publish only a subset of the original variables recorded for a study, such that the inclusion of the variables in the published work is selectively based on the results. Statistically significant results have a higher likelihood of being fully reported compared to nonsignificant results, and a significant proportion of published articles describe outcome variables or data analyses that differ from the pre-specified trial protocol as originally conceived. Recognition that publication bias and outcome reporting bias contribute to a distorted perception of drug effects—inflated estimates of efficacy and underreporting of adverse events—has led to the development and expansion of publicly accessible databases that contain transparent information about clinical trials and their results.
- Dwan K., Altman D.G., Arnaiz J.A., Bloom J., Chan A.W., Cronin E., Williamson P.R. (2008). Systematic review of the empirical evidence of study publication bias and outcome reporting bias. PLoS One, 3(8). Retrieved from http://www.plosone.org/article/info:doi/10.1371/journal.pone.0003081
10.1371/journal.pone.0003081 Crossref, Google Scholar - European Medicines Agency. (2010). European Public Assessment Reports. Retrieved from http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/general/general_content_000433.jsp&murl=&mid= Google Scholar
- Ioannides J.P.A. (2009). Adverse events in randomized trials: Neglected, restricted, distorted, and silenced. Archives of Internal Medicine, 169, 1737–1739.
10.1001/archinternmed.2009.313 Crossref Medline, Google Scholar - McGauran N., Wieseler B., Kreis J., Schüler Y.B., Kölsch H., Kaiser T. (2010). Reporting bias in medical research—A narrative review. Trials, 11(37). Retrieved from http://www.trialsjournal.com/content/11/1/37
10.1186/1745-6215-11-37 Crossref, Google Scholar - Pannucci C.J., Wilkins E.G. (2010). Identifying and avoiding bias in research. Plastic and Reconstructive Surgery, 126, 619–625.
10.1097/PRS.0b013e3181de24bc Crossref Medline, Google Scholar - Tse T., Williams R.J., Zarin D.A. (2009). Reporting “basic results” in ClinicalTrials.gov. Chest, 136, 295–303.
10.1378/chest.08-3022 Crossref Medline, Google Scholar - U.S. Food and Drug Administration. (2002). Guidance for industry: Information program on clinical trials for serious or life-threatening diseases and conditions. Retrieved from http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM079775.pdf Google Scholar
- U.S. Food and Drug Administration. (2009). Food and Drug Administration Modernization Act (FDAMA) of 1997. Retrieved from http://www.fda.gov/RegulatoryInformation/Legislation/FederalFoodDrugandCosmeticActFDCAct/SignificantAmendmentstotheFDCAct/FDAMA/default.htm Google Scholar
- Young N.S., Ioannides J.P.A., Al-Ubaydli O. (2008). Why current publication practices may distort science. PLoS Medicine, 5(10). Retrieved from http://www.plosmedicine.org/article/info:doi/10.1371/journal.pmed.0050201
10.1371/journal.pmed.0050201 Crossref, Google Scholar - Young S.N. (2009). Bias in the research literature and conflict of interest: An issue for publishers, editors, reviewers and authors, and it is not just about the money. Journal of Psychiatry and Neuroscience, 34, 412–417. Medline, Google Scholar
