Stopping the active intervention: CARET

被引:19
作者
Bowen, DJ
Thornquist, M
Anderson, K
Barnett, M
Powell, C
Goodman, G
Omenn, G
机构
[1] Fred Hutchinson Canc Res Ctr, Seattle, WA 98109 USA
[2] Swedish Med Ctr, Inst Canc, Seattle, WA USA
[3] Univ Michigan, Ann Arbor, MI 48109 USA
来源
CONTROLLED CLINICAL TRIALS | 2003年 / 24卷 / 01期
关键词
randomized trial design; stopping rules; participant retention;
D O I
10.1016/S0197-2456(02)00277-5
中图分类号
R-3 [医学研究方法]; R3 [基础医学];
学科分类号
1001 ;
摘要
The Carotene and Retinol Efficacy Trial (CARET) was a large, multicenter randomized chemoprevention trial designed to test a combined lung cancer prevention agent in heavy smokers and workers exposed to asbestos. In January 1996, the CARET Steering Committee decided to stop the intervention due to an adverse effect. This paper describes the decision process used to apply the stopping rules and the activities engaged in by CARET participants and staff to implement the decision. The most important activity was to draft and mail a letter to the participants informing them of the disappointing CARET results and asking them to stop taking the study vitamins and to return any unused study vitamins. The steering committee, with the support of the National Cancer Institute, planned to follow participants for disease endpoints and smoking behavior for 5 years. These activities led to smooth closure of active intervention and maintained high retention rates during the transition. (C) 2003 Elsevier Science Inc. All rights reserved.
引用
收藏
页码:39 / 50
页数:12
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