Sample size tables for exact single-stage phase II designs

被引:321
作者
A'Hern, RP [1 ]
机构
[1] Royal Marsden NHS Trust, Dept Comp & Informat, London SW3 6JJ, England
关键词
D O I
10.1002/sim.721
中图分类号
Q [生物科学];
学科分类号
07 ; 0710 ; 09 ;
摘要
Tables for single-phase II trials based on the exact binomial distribution are presented. These are preferable to those generated using Fleming's design, which are based on the normal approximation and can give rise to anomalous results. For example, if the upper success rate is accepted, the lower success rate, which the trial is designed to reject, may be included in the final confidence interval for the proportion being estimated. Copyright (C) 2001 John Wiley & Sons, Ltd.
引用
收藏
页码:859 / 866
页数:8
相关论文
共 7 条
[1]  
Chen TT, 1997, STAT MED, V16, P2701, DOI 10.1002/(SICI)1097-0258(19971215)16:23<2701::AID-SIM704>3.0.CO
[2]  
2-1
[3]   AN OPTIMAL 3-STAGE DESIGN FOR PHASE-II CLINICAL-TRIALS [J].
ENSIGN, LG ;
GEHAN, EA ;
KAMEN, DS ;
THALL, PF .
STATISTICS IN MEDICINE, 1994, 13 (17) :1727-1736
[4]   ONE-SAMPLE MULTIPLE TESTING PROCEDURE FOR PHASE-II CLINICAL-TRIALS [J].
FLEMING, TR .
BIOMETRICS, 1982, 38 (01) :143-151
[5]  
Machin D., 1997, SAMPLE SIZE TABLES C, V2nd
[6]   OPTIMAL 2-STAGE DESIGNS FOR PHASE-II CLINICAL-TRIALS [J].
SIMON, R .
CONTROLLED CLINICAL TRIALS, 1989, 10 (01) :1-10
[7]   WHOLE-BODY HYPERTHERMIA IN CANCER-THERAPY - A REPORT OF A PHASE I-II STUDY [J].
VANDERZEE, J ;
VANRHOON, GC ;
WIKEHOOLEY, JL ;
FAITHFULL, NS ;
REINHOLD, HS .
EUROPEAN JOURNAL OF CANCER & CLINICAL ONCOLOGY, 1983, 19 (09) :1189-1200