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

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Data Monitoring in Clinical Trials

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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.

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Author information

Authors and Affiliations

  1. Bethesda, Maryland

    Lawrence M. Friedman

  2. Department of Biostatistics and Medical Informatics, University of Wisconsin, Madison, Wisconsin

    David L. DeMets

  3. Division of Biostatistics, The University of Texas Health Sciences Center at Houston, School of Public Health, Houston, Texas

    Robert Hardy

Authors
  1. Lawrence M. Friedman
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  2. David L. DeMets
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  3. Robert Hardy
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Editor information

Editors and Affiliations

  1. Department of Biostatistics and Medical Informatics, University of Wisconsin Medical School, Madison, WI, 53972-4675, USA

    David L. DeMets

  2. Department of Public Health Sciences, Wake Forest University School of Medicine, Winston-Salem, NC, 27157, USA

    Curt D. Furberg

  3. Bethesda, MD, USA

    Lawrence M. Friedman

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© 2006 Springer Science+Business Media, Inc.

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Friedman, L.M., DeMets, D.L., Hardy, R. (2006). Data and Safety Monitoring in the Beta-Blocker Heart Attack Trial: Early Experience in Formal Monitoring Methods. In: DeMets, D.L., Furberg, C.D., Friedman, L.M. (eds) Data Monitoring in Clinical Trials. Springer, New York, NY. https://doi.org/10.1007/0-387-30107-0_6

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