A BAYESIAN STRATEGY FOR SCREENING CANCER TREATMENTS PRIOR TO PHASE-II CLINICAL-EVALUATION

被引:35
作者
THALL, PF [1 ]
ESTEY, EH [1 ]
机构
[1] UNIV TEXAS,MD ANDERSON CANC CTR,DEPT HEMATOL,HOUSTON,TX 77030
关键词
D O I
10.1002/sim.4780121103
中图分类号
Q [生物科学];
学科分类号
07 ; 0710 ; 09 ;
摘要
We address the problem of selecting a treatment for phase II evaluation when several candidate treatments emerging from phase I testing are available. A pre-phase II Bayesian selection design which randomizes patients among treatments is proposed. The patient group in the trial has prognosis more favourable than that of phase I patients but less favourable than the target group of the subsequent phase II trial. The patient response rate distribution in each treatment arm is continually updated during the trial for comparison with early termination cutoffs, and the best final treatment must satisfy a minimal posterior efficacy criterion. The primary aim is to replace the usual informal treatment selection process with a fair comparison formally based on a combination of prior opinion and clinical data.
引用
收藏
页码:1197 / 1211
页数:15
相关论文
共 12 条
[1]   INTERIM ANALYSIS IN CLINICAL-TRIALS - THE ROLE OF THE LIKELIHOOD PRINCIPLE [J].
BERRY, DA .
AMERICAN STATISTICIAN, 1987, 41 (02) :117-122
[2]  
BERRY DA, 1985, STAT MED, V4, P521, DOI 10.1002/sim.4780040412
[3]   DETERMINATION OF NUMBER OF PATIENTS REQUIRED IN A PRELIMINARY AND A FOLLOW-UP TRIAL OF A NEW CHEMOTHERAPEUTIC AGENT [J].
GEHAN, EA .
JOURNAL OF CHRONIC DISEASES, 1961, 13 (04) :346-&
[4]   SELECTING THE BEST BINOMIAL POPULATION - PARAMETRIC EMPIRICAL BAYES APPROACH [J].
GUPTA, SS ;
LIANG, TC .
JOURNAL OF STATISTICAL PLANNING AND INFERENCE, 1989, 23 (01) :21-31
[5]   APPROXIMATE BAYESIAN-INFERENCE IN CONDITIONALLY INDEPENDENT HIERARCHICAL-MODELS (PARAMETRIC EMPIRICAL BAYES MODELS) [J].
KASS, RE ;
STEFFEY, D .
JOURNAL OF THE AMERICAN STATISTICAL ASSOCIATION, 1989, 84 (407) :717-726
[6]   RANDOMIZATION IN CLINICAL-TRIALS - CONCLUSIONS AND RECOMMENDATIONS [J].
LACHIN, JM ;
MATTS, JP ;
WEI, LJ .
CONTROLLED CLINICAL TRIALS, 1988, 9 (04) :365-374
[7]  
MORRIS CN, 1983, J AM STAT ASSOC, V78, P47, DOI 10.2307/2287098
[8]  
SIMON R, 1985, CANCER TREAT REP, V69, P1375
[9]  
THALL PF, 1988, BIOMETRIKA, V75, P303, DOI 10.2307/2336178
[10]   A 2-STAGE DESIGN FOR CHOOSING AMONG SEVERAL EXPERIMENTAL TREATMENTS AND A CONTROL IN CLINICAL-TRIALS [J].
THALL, PF ;
SIMON, R ;
ELLENBERG, SS .
BIOMETRICS, 1989, 45 (02) :537-547