Adaptive group sequential designs for clinical trials:: Combining the advantages of adaptive and of classical group sequential approaches

被引:255
作者
Müller, HH [1 ]
Schäfer, H [1 ]
机构
[1] Univ Marburg, Inst Med Biometry & Epidemiol, D-35037 Marburg, Germany
关键词
adaptive design; clinical trial; combination rule; group sequential test; interim analysis;
D O I
10.1111/j.0006-341X.2001.00886.x
中图分类号
Q [生物科学];
学科分类号
07 ; 0710 ; 09 ;
摘要
A general method is presented integrating the concept of adaptive interim analyses into classical group sequential testing. This allows the researcher to represent every group sequential plan as ail adaptive trial design and to make design changes during the course of the trial after every interim analysis in the same way as with adaptive designs. The concept of adaptive trial designing is thereby generalized to a large variety of possible sequential plans.
引用
收藏
页码:886 / 891
页数:6
相关论文
共 27 条
[21]   GROUP SEQUENTIAL METHODS IN DESIGN AND ANALYSIS OF CLINICAL-TRIALS [J].
POCOCK, SJ .
BIOMETRIKA, 1977, 64 (02) :191-200
[22]   Designed extension of studies based on conditional power [J].
Proschan, MA ;
Hunsberger, SA .
BIOMETRICS, 1995, 51 (04) :1315-1324
[23]   Statistical inference for self-designing clinical trials with a one-sided hypothesis [J].
Shen, Y ;
Fisher, L .
BIOMETRICS, 1999, 55 (01) :190-197
[24]   EXACT CONFIDENCE-INTERVALS FOLLOWING A GROUP SEQUENTIAL TEST [J].
TSIATIS, AA ;
ROSNER, GL ;
MEHTA, CR .
BIOMETRICS, 1984, 40 (03) :797-803
[25]   APPROXIMATELY OPTIMAL ONE-PARAMETER BOUNDARIES FOR GROUP SEQUENTIAL TRIALS [J].
WANG, SK ;
TSIATIS, AA .
BIOMETRICS, 1987, 43 (01) :193-199
[26]   A technical note on the power determination for Fisher's combination test [J].
Wassmer, G .
BIOMETRICAL JOURNAL, 1997, 39 (07) :831-838
[27]   A comparison of two methods for adaptive interim analyses in clinical trials [J].
Wassmer, G .
BIOMETRICS, 1998, 54 (02) :696-705