作者: Gilbert S. Omenn , Linda Rosenstock , Ina Gylys-Colwell , Scott Barnhart , Mark D. Thornquist
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摘要: Pilot studies are an essential component for major chemoprevention trials. Prior to initiating the multicenter Carotene and Retinol Efficacy Trial assess effectiveness of beta-carotene retinol preventing lung cancer, we conducted pilot in Seattle between 1985 1988 two high risk populations: current former heavy smokers asbestos-exposed workers. The Asbestos Workers Study demonstrated that recruitment participants with relevant factors was feasible from identified sources. We documented negligible toxicity adherence protocol, schedule, intervention. Results led extension placebo run-in period, changes eligibility criteria, improvements strategies scheduling, elimination stratification by randomization, modifications study vitamin dosage side effects monitoring, refinement trial design parameters Trial. Smokers is reported accompanying article (G. E. Goodman et al., Cancer Epidemiol., Biomarkers & Prev., 2: 389-396, 1993).