Continual reassessment method: A likelihood approach

被引:223
作者
OQuigley, JO
Shen, LZ
机构
[1] UNIV CALIF SAN DIEGO,DEPT MATH,LA JOLLA,CA 92093
[2] PROCTER & GAMBLE CO,PHARMACEUT,BIOMETR & STAT SCI,CINCINNATI,OH 45242
关键词
clinical trial; continual reassessment method; dose escalation; dose finding studies; maximum likelihood; phase; 1; trial; toxicity;
D O I
10.2307/2532905
中图分类号
Q [生物科学];
学科分类号
07 ; 0710 ; 09 ;
摘要
The continual reassessment method as described by O'Quigley, Pepe, and Fisher (1990, Biometrics 46, 33-48) leans to a large extent upon a Bayesian methodology. Initial experimentation and sequential updating are carried out in a natural way within the context of a Bayesian framework. In this paper we argue that such a framework is easily changed to a more classic one leaning upon likelihood theory. The essential features of the continual reassessment method remain unchanged. In particular, large sample properties are the same unless the prior is degenerate. For small samples, and as far as the final recommended dose level is concerned, simulations indicate that there is not much to choose between a likelihood approach and a Bayesian one. However, for in-trial allocation of dose levels to patients, there are some differences and these are discussed. In contrast to the Bayesian approach, a likelihood one requires some extra effort to get off the ground. This is because the likelihood equation has no solution until we observe a toxicity. Initially then we suggest working with either a standard Up-and-Down scheme or standard continual reassessment method until toxicity is observed and then switching to the new scheme.
引用
收藏
页码:673 / 684
页数:12
相关论文
共 9 条
[1]  
CHEVRET S, 1993, STAT MED, V12, P1093
[2]   A COMPARISON OF 2 PHASE-I TRIAL DESIGNS [J].
KORN, EL ;
MIDTHUNE, D ;
CHEN, TT ;
RUBINSTEIN, LV ;
CHRISTIAN, MC ;
SIMON, RM .
STATISTICS IN MEDICINE, 1994, 13 (18) :1799-1806
[3]   MODEL-GUIDED DETERMINATION OF MAXIMUM TOLERATED DOSE IN PHASE-I CLINICAL-TRIALS - EVIDENCE FOR INCREASED PRECISION [J].
MICK, R ;
RATAIN, MJ .
JOURNAL OF THE NATIONAL CANCER INSTITUTE, 1993, 85 (03) :217-223
[4]   METHODS FOR DOSE FINDING STUDIES IN CANCER CLINICAL-TRIALS - A REVIEW AND RESULTS OF A MONTE-CARLO STUDY [J].
OQUIGLEY, J ;
CHEVRET, S .
STATISTICS IN MEDICINE, 1991, 10 (11) :1647-1664
[5]   CONTINUAL REASSESSMENT METHOD - A PRACTICAL DESIGN FOR PHASE-1 CLINICAL-TRIALS IN CANCER [J].
OQUIGLEY, J ;
PEPE, M ;
FISHER, L .
BIOMETRICS, 1990, 46 (01) :33-48
[6]   ESTIMATING THE PROBABILITY OF TOXICITY AT THE RECOMMENDED DOSE FOLLOWING A PHASE-I CLINICAL-TRIAL IN CANCER [J].
OQUIGLEY, J .
BIOMETRICS, 1992, 48 (03) :853-862
[7]  
SHEN LZ, 1996, IN PRESS BIOMETRIKA
[8]  
SILVAPULLE MJ, 1981, J ROY STAT SOC B MET, V43, P310
[9]   DESIGN AND ANALYSIS OF PHASE-I CLINICAL-TRIALS [J].
STORER, BE .
BIOMETRICS, 1989, 45 (03) :925-937