Confirmatory clinical trials with an adaptive design

被引:21
作者
Koch, Armin [1 ]
机构
[1] Bundesinst Arzneimittel & Medizinprod, D-53175 Bonn, Germany
关键词
adaptive designs; biostatistics; experimental design; phase III clinical trials;
D O I
10.1002/bimj.200510239
中图分类号
Q [生物科学];
学科分类号
07 ; 0710 ; 09 ;
摘要
Adaptive designs are one of the most promising developments in statistics with applications to clinical trials. Obviously, knowledge at the beginning of a clinical trial will always be limited. Thus it may seem logical that the knowledge from accumulating information should be used to optimize the design of the trial. This paper discusses conditions under which this may be possible in phase III clinical trials where the principal aim is confirmation of hypotheses that have been developed in earlier stages of drug development.
引用
收藏
页码:574 / 585
页数:12
相关论文
共 13 条
[1]  
Abel U, 1999, J CLIN EPIDEMIOL, V52, P487
[2]   EVALUATION OF EXPERIMENTS WITH ADAPTIVE INTERIM ANALYSES [J].
BAUER, P ;
KOHNE, K .
BIOMETRICS, 1994, 50 (04) :1029-1041
[3]   Recursive combination tests [J].
Brannath, W ;
Posch, M ;
Bauer, P .
JOURNAL OF THE AMERICAN STATISTICAL ASSOCIATION, 2002, 97 (457) :236-244
[4]  
*CPMP, 2000, CPMPEWP233099
[5]   Blinded sample size reassessment in non-inferiority and equivalence trials [J].
Friede, T ;
Kieser, M .
STATISTICS IN MEDICINE, 2003, 22 (06) :995-1007
[6]   Mid-course sample size modification in clinical trials based on the observed treatment effect [J].
Jennison, C ;
Turnbull, BW .
STATISTICS IN MEDICINE, 2003, 22 (06) :971-993
[7]  
Jennison C., 2000, GROUP SEQUENTIAL MET
[8]  
Kieser M, 2000, STAT MED, V19, P901, DOI 10.1002/(SICI)1097-0258(20000415)19:7<901::AID-SIM405>3.0.CO
[9]  
2-L
[10]  
Koch A, 2001, DRUG INF J, V35, P1019, DOI 10.1177/009286150103500341