Omenn G S, Goodman G E, Thornquist M D, Rosenstock L, Barnhart S, Gylys-Colwell I, Metch B, Lund B
Division of Public Health Sciences, Fred Hutchinson Cancer Research Center, Seattle, Washington 98104.
Cancer Epidemiol Biomarkers Prev. 1993 Jul-Aug;2(4):381-7.
Pilot studies are an essential component for major chemoprevention trials. Prior to initiating the multicenter Carotene and Retinol Efficacy Trial to assess the effectiveness of beta-carotene and retinol for preventing lung cancer, we conducted pilot studies in Seattle between 1985 and 1988 in two high risk populations: current and former heavy smokers and asbestos-exposed workers. The Asbestos Workers Pilot Study for the Carotene and Retinol Efficacy Trial demonstrated that recruitment of asbestos-exposed participants with relevant risk factors was feasible from identified sources. We documented negligible toxicity and high adherence with the protocol, schedule, and intervention. Results from the pilot led to extension of the placebo run-in period, changes in the eligibility criteria, improvements in recruitment strategies and scheduling, elimination of stratification by risk factors in randomization, modifications of study vitamin dosage and of side effects monitoring, and refinement of trial design parameters for Carotene and Retinol Efficacy Trial. The Smokers Pilot is reported in the accompanying article (G. E. Goodman et al., Cancer Epidemiol., Biomarkers & Prev., 2: 389-396, 1993).
试点研究是大型化学预防试验的重要组成部分。在启动多中心胡萝卜素与视黄醇功效试验以评估β-胡萝卜素和视黄醇预防肺癌的有效性之前，我们于1985年至1988年在西雅图对两个高危人群进行了试点研究：当前和既往的重度吸烟者以及接触石棉的工人。胡萝卜素与视黄醇功效试验的石棉工人试点研究表明，从已确定的来源招募具有相关风险因素的接触石棉参与者是可行的。我们记录到毒性可忽略不计，并且对方案、时间表和干预措施的依从性很高。试点研究的结果导致延长了安慰剂导入期、改变了入选标准、改进了招募策略和时间表、在随机分组中取消了按风险因素分层、修改了研究维生素剂量和副作用监测方法，以及完善了胡萝卜素与视黄醇功效试验的试验设计参数。吸烟者试点研究见随附文章（G. E. 古德曼等人，《癌症流行病学、生物标志物与预防》，2: 389 - 396, 1993）。
