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

Anthony B. Miller, Julie Buring and O. Dale Williams
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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

Chapter Case 15 in Data Monitoring in Clinical Trials, 2006, pp 220-227 from Springer

Abstract: 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.

Keywords: Lung Cancer; Case Study Approach; Retinyl Palmitate; National Breast Screening; Adverse Trend (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_20

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DOI: 10.1007/0-387-30107-0_20

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