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Stopping the Carotene and Retinol Efficacy Trial: The Viewpoint of the Safety and Endpoint Monitoring Committee

In: Data Monitoring in Clinical Trials

Author

Listed:
  • Anthony B. Miller
  • Julie Buring

    (Harvard Medical School, Department of Medicine, Brigham and Women’s Hospital)

  • O. Dale Williams

    (University of Alabama, Division of Preventive Medicine, Department of Medicine)

Abstract

We describe our experience with the events that occurred when it began to be suspected that beta-carotene in non-physiological doses had an unexpected adverse effect on the incidence and mortality from lung cancer. Initially, we delayed a decision to recommend stopping the Carotene and Retinol Efficacy Trial (CARET) for a year, until we were convinced that an adverse trend seen in the first interim analysis of the trial persisted. In hindsight, this seems to have been the correct decision.

Suggested Citation

  • Anthony B. Miller & Julie Buring & O. Dale Williams, 2006. "Stopping the Carotene and Retinol Efficacy Trial: The Viewpoint of the Safety and Endpoint Monitoring Committee," Springer Books, in: David L. DeMets & Curt D. Furberg & Lawrence M. Friedman (ed.), Data Monitoring in Clinical Trials, chapter 0, pages 220-227, Springer.
    • Handle: RePEc:spr:sprchp:978-0-387-30107-5_20
    DOI: 10.1007/0-387-30107-0_20
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