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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References
IARC Handbooks on Cancer Prevention. Volume 2 Carotenoids. 1998. Lyon, International Agency for Research on Cancer.
O’Brien PC, Fleming TR. 1979. A multiple testing procedure for clinical trials. Biometrics 35:549–556.
Bowen DJ, Thornqvist M, Anderson K, Barnett M, Powell C, Goodman G, Omenn G. 2003. Stopping the active intervention: CARET. Control Clin Trials 24:39–50.
The Alpha-Tocopherol Beta Carotene Prevention Study Group. 1994. The effect of vitamin E and beta carotene on the incidence of lung cancer and other cancers in male smokers. N Engl J Med 330:1029–1035.
Hennekens CH Buring JE, Manson JE, Stampfer M, Rosner B, Cook NR, et al. 1996. Lack of long-term supplementation with beta carotene on the incidence of malignant neoplasms and cardiovascular disease. N Engl J Med 334:1145–1149.
Miller AB, To T, Baines CJ, Wall C. 2000. Canadian National Breast Screening Study-2: 13-year results of a randomized trial in women age 50–59 years. J Natl Cancer Inst 92:1490–1499.
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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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