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.
Dr. Frank Iber was also a member of the SEMC during the events described in this paper, but could not be reached by the first author and therefore had no opportunity to participate in the preparation of this manuscript.
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Miller, A.B., Buring, J., Williams, O.D. (2006). Stopping the Carotene and Retinol Efficacy Trial: The Viewpoint of the Safety and Endpoint Monitoring Committee. 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_20
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DOI: https://doi.org/10.1007/0-387-30107-0_20
Publisher Name: Springer, New York, NY
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