STATISTICAL DESIGN AND MONITORING OF THE CAROTENE AND RETINOL EFFICACY TRIAL (CARET)

被引:57
作者
THORNQUIST, MD
OMENN, GS
GOODMAN, GE
GRIZZLE, JE
ROSENSTOCK, L
BARNHART, S
ANDERSON, GL
HAMMAR, S
BALMES, J
CHERNIACK, M
CONE, J
CULLEN, MR
GLASS, A
KEOGH, JP
MEYSKENS, F
VALANIS, B
WILLIAMS, JH
机构
[1] UNIV WASHINGTON,DEPT BIOSTAT,SEATTLE,WA 98195
[2] UNIV WASHINGTON,DEPT ENVIRONM HLTH,SEATTLE,WA 98195
[3] UNIV WASHINGTON,DEPT MED,SEATTLE,WA 98195
[4] SWEDISH MED CTR,INST TUMOR,SEATTLE,WA
[5] DIAGNOST SPECIALTIES LAB,BREMERTON,WA
[6] UNIV CALIF SAN FRANCISCO,DEPT MED,SAN FRANCISCO,CA 94143
[7] YALE UNIV,DEPT MED,NEW HAVEN,CT 06520
[8] KAISER PORTLAND CTR HLTH RES,PORTLAND,OR
[9] UNIV MARYLAND,DEPT MED,BALTIMORE,MD 21201
[10] UNIV CALIF IRVINE,DEPT MED,ORANGE,CA 92668
[11] UNIV CALIF IRVINE,CTR CANC,ORANGE,CA 92668
来源
CONTROLLED CLINICAL TRIALS | 1993年 / 14卷 / 04期
关键词
CHEMOPREVENTION; LUNG CANCER; SAMPLE SIZE; MONITORING RULES;
D O I
10.1016/0197-2456(93)90228-6
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
CARET is a chemoprevention trial of beta-carotene and vitamin A with lung cancer as the primary outcome. Participants at high risk for lung cancer are drawn from two populations: asbestos-exposed workers and heavy smokers. The intervention is a daily combination of 30 mg beta-carotene and 25,000 IU vitamin A as retinyl palmitate. Nearly 18,000 participants will be followed for a mean 6 years, yielding over 100,000 person-years of follow-up. We project that this sample size will have 80% power to detect a 23% decrease in the incidence of lung cancer cases. The purpose of this paper is to present the values of the key sample size parameters of CARET; our schemes for monitoring CARET for sample size adequacy, incidence of side effects, and efficacy of the study vitamins; an overview of the data collected; and plans for the primary, secondary, and ancillary analyses to be performed at the end of the trial. These approaches to the design, monitoring, and analysis of CARET are applicable for many other prevention trials.
引用
收藏
页码:308 / 324
页数:17
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