MONITORING VERSUS INTERIM ANALYSIS OF CLINICAL-TRIALS - A PERSPECTIVE FROM THE PHARMACEUTICAL-INDUSTRY

被引:15
作者
ENAS, GG
DORNSEIF, BE
SAMPSON, CB
ROCKHOLD, FW
WUU, J
机构
[1] SK&F LABS,PHILADELPHIA,PA 19101
[2] WARNER LAMBERT PARKE DAVIS,DIV PHARMACEUT RES,ANN ARBOR,MI 48105
来源
CONTROLLED CLINICAL TRIALS | 1989年 / 10卷 / 01期
关键词
D O I
10.1016/0197-2456(89)90018-4
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
引用
收藏
页码:57 / 70
页数:14
相关论文
共 32 条
[1]   REPEATED SIGNIFICANCE TESTS ON ACCUMULATING DATA [J].
ARMITAGE, P ;
MCPHERSO.CK ;
ROWE, BC .
JOURNAL OF THE ROYAL STATISTICAL SOCIETY SERIES A-GENERAL, 1969, 132 :235-&
[2]  
ARMITAGE P, 1971, SEQUENTIAL MED TRIAL
[3]  
BERRY DA, 1985, STAT MED, V4, P521, DOI 10.1002/sim.4780040412
[4]  
BERRY DA, 1988, BIOMETRIC SOC M ENAR
[5]  
CANNER PL, 1976, 9TH P INT BIOM C, V1, P261
[6]   AN INTRODUCTION TO EMPIRICAL BAYES DATA-ANALYSIS [J].
CASELLA, G .
AMERICAN STATISTICIAN, 1985, 39 (02) :83-87
[7]   A CLINICAL-TRIAL WITH AN INTERIM ANALYSIS [J].
CHI, PY ;
BRISTOL, DR ;
CASTELLANA, JV .
STATISTICS IN MEDICINE, 1986, 5 (04) :387-392
[8]   EARLY DECISION IN CLINICAL-TRIALS WHEN THE TREATMENT DIFFERENCES ARE SMALL - EXPERIENCE OF A CONTROLLED TRIAL IN HEAD TRAUMA [J].
CHOI, SC ;
SMITH, PJ ;
BECKER, DP .
CONTROLLED CLINICAL TRIALS, 1985, 6 (04) :280-288
[9]   STATISTICAL ASPECTS OF EARLY TERMINATION IN THE BETA-BLOCKER HEART ATTACK TRIAL [J].
DEMETS, DL ;
HARDY, R ;
FRIEDMAN, LM ;
LAN, KKG .
CONTROLLED CLINICAL TRIALS, 1984, 5 (04) :362-372
[10]   A CASE-REPORT OF DATA MONITORING EXPERIENCE - THE NOCTURNAL OXYGEN-THERAPY TRIAL [J].
DEMETS, DL ;
WILLIAMS, GW ;
BROWN, BW .
CONTROLLED CLINICAL TRIALS, 1982, 3 (02) :113-124