Data and Safety Monitoring in the Beta-Blocker Heart Attack Trial: Early Experience in Formal Monitoring Methods

Lawrence M. Friedman, David L. DeMets and Robert Hardy
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David L. DeMets: University of Wisconsin, Department of Biostatistics and Medical Informatics
Robert Hardy: The University of Texas Health Sciences Center at Houston, School of Public Health, Division of Biostatistics

Chapter Case 2 in Data Monitoring in Clinical Trials, 2006, pp 64-72 from Springer

Abstract: Abstract The Beta-Blocker Heart Attack Trial (BHAT) compared the beta-blocker propranolol against placebo in 3,837 people who had recently had a myocardial infarction. The primary outcome was total mortality. The trial ended nine months ahead of schedule because of clear benefit from propranolol. The independent monitoring committee considered several newly developed statistical approaches in recommending early stopping, as well as other factors, including what had been communicated in the consent form to the participants.

Keywords: Conditional Power; Propranolol Group; Monitoring Boundary; Control Group Event; Heart Attack Patient (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_6

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DOI: 10.1007/0-387-30107-0_6

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