Data Monitoring for the Aspirin Component of the Physicians’ Health Study: Issues in Early Termination for a Major Secondary Endpoint

David L. DeMets and Charles H. Hennekens
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David L. DeMets: University of Wisconsin, Department of Biostatistics and Medical Informatics
Charles H. Hennekens: University of Miami School of Medicine and Florida Atlantic University

Chapter Case 3 in Data Monitoring in Clinical Trials, 2006, pp 73-84 from Springer

Abstract: Abstract The Physicians’ Health Study was a randomized, double-blind, placebo controlled, 2 #x00D7; 2 factorial primary prevention trial whose primary aims were to test whether aspirin reduces risks of cardiovascular disease (CVD) mortality and beta-carotene decreases the incidence of cancer. The trial was conducted among 22,071 apparently healthy U.S. male physicians aged 40–84 years at entry. After five years of treatment and follow-up, on December 17, 1987, the independent Data and Safety Monitoring Board (DSMB) recommended unanimously the early termination of the aspirin component due principally to the emergence of a statistically extreme (p

Keywords: Case Study Approach; Conditional Power; United States Preventive Service Task; Coronary Drug Project; Health Study Research Group (search for similar items in EconPapers)
Date: 2006
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Persistent link: https://EconPapers.repec.org/RePEc:spr:sprchp:978-0-387-30107-5_7

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DOI: 10.1007/0-387-30107-0_7

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