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

In: Data Monitoring in Clinical Trials

Author

Listed:
  • 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)

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

Suggested Citation

  • David L. DeMets & Charles H. Hennekens, 2006. "Data Monitoring for the Aspirin Component of the Physicians’ Health Study: Issues in Early Termination for a Major Secondary Endpoint," Springer Books, in: David L. DeMets & Curt D. Furberg & Lawrence M. Friedman (ed.), Data Monitoring in Clinical Trials, chapter 0, pages 73-84, Springer.
    • Handle: RePEc:spr:sprchp:978-0-387-30107-5_7
    DOI: 10.1007/0-387-30107-0_7
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