Thomas R. Fleming, PhD
Acknowledgment: The author thanks Williamson Bradford and Steven Porter for their supportive role in dissemination of scientifically reliable insights about clinical trials evaluating Actimmune in IPF.
Grant Support: By the National Institutes of Health, National Institute of Allergy and Infectious Diseases (R37 AI 29168).
Potential Conflicts of Interest: Disclosures can be viewed at www.acponline.org/authors/icmje/ConflictOfInterestForms.do?msNum=M10-1264.
Requests for Single Reprints: Thomas R. Fleming, PhD, Department of Biostatistics, Box 357232, University of Washington, Seattle, WA 98195-7232; e-mail, firstname.lastname@example.org.
Fleming TR. Clinical Trials: Discerning Hype From Substance. Ann Intern Med. 2010;153:400-406. doi: 10.7326/0003-4819-153-6-201009210-00008
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Published: Ann Intern Med. 2010;153(6):400-406.
This article has been corrected. For original version, click â€œOriginal Version (PDF)â€ in column 2.
The interest in being able to interpret and report results in clinical trials as being favorable is pervasive throughout health care research. This important source of bias needs to be recognized, and approaches need to be implemented to effectively address it. The prespecified primary analyses of the primary and secondary end points of a clinical trial should be clearly specified when disseminating results in press releases and journal publications. There should be a focus on these analyses when interpreting the results. A substantial risk for biased conclusions is produced by conducting exploratory analyses with an intention to establish that the benefit-to-risk profile of the experimental intervention is favorable, rather than to determine whether it is. In exploratory analyses, P values will be misleading when the actual sampling context is not presented to allow for proper interpretation, and the effect sizes of outcomes having particularly favorable estimates are probably overestimated because of â€œrandom highâ€ bias. Performing exploratory analyses should be viewed as generating hypotheses that usually require reassessment in prospectively conducted confirmatory trials. Awareness of these issues will meaningfully improve our ability to be guided by substance, not hype, in making evidence-based decisions about medical care.
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Hematology/Oncology, Pulmonary/Critical Care, Healthcare Delivery and Policy, Interstitial Lung Disease, Prevention/Screening.
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