Bayesian evaluation of group sequential clinical trial designs

Clinical trial designs often incorporate a sequential stopping rule to serve as a guide in the early termination of a study. When choosing a particular stopping rule, it is most common to examine frequentist operating characteristics such as type I error, statistical power, and precision of confidence intervals (Statist. Med. 2005, in revision). Increasingly, however, clinical trials are designed and analysed in the Bayesian paradigm. In this paper, we describe how the Bayesian operating characteristics of a particular stopping rule might be evaluated and communicated to the scientific community. In particular, we consider a choice of probability models and a family of prior distributions that allows concise presentation of Bayesian properties for a specified sampling plan.

[1]  D. Heitjan,et al.  Bayesian interim analysis of phase II cancer clinical trials. , 1997, Statistics in medicine.

[2]  Jeffrey D Blume,et al.  Likelihood methods for measuring statistical evidence , 2002, Statistics in medicine.

[3]  S. Emerson,et al.  A Unifying Family of Group Sequential Test Designs , 1999, Biometrics.

[4]  Peter D. Hoff,et al.  A Comparison of Parametric and Coarsened Bayesian Interval Estimation in the Presence of a Known Mean-Variance Relationship , 2005 .

[5]  R. Royall.  Statistical Evidence: A Likelihood Paradigm , 1997 .

[6]  B. Turnbull,et al.  Group Sequential Methods with Applications to Clinical Trials , 1999 .

[7]  D. Gillen,et al.  Evaluation of Group Sequential Clinical Trial Designs , 2004 .

[8]  A. Birnbaum.  On the Foundations of Statistical Inference , 1962 .

[9]  Donald A. Berry,et al.  Interim analysis in clinical trials; the role of the likelihood principle , 1987 .

[10]  John F. Monahan,et al.  Bootstrap methods using prior information , 1986 .

[11]  D. Berry.  Bayesian Statistics and the Efficiency and Ethics of Clinical Trials , 2004 .

[12]  T. Louis,et al.  Bayes and Empirical Bayes Methods for Data Analysis. , 1997 .

[13]  P M Fayers,et al.  Tutorial in biostatistics Bayesian data monitoring in clinical trials. , 1997, Statistics in medicine.

[14]  Thomas M. Cover,et al.  Elements of Information Theory , 2005 .

[15]  J. Monahan,et al.  Proper likelihoods for Bayesian analysis , 1992 .

[16]  David J. Spiegelhalter,et al.  Bayesian Approaches to Randomized Trials , 1994, Bayesian Biostatistics.

[17]  D A Berry,et al.  A case for Bayesianism in clinical trials. , 1993, Statistics in medicine.

[18]  H. Raiffa,et al.  Introduction to Statistical Decision Theory , 1996 .

[19]  D. Spiegelhalter,et al.  Monitoring clinical trials: conditional or predictive power? , 1986, Controlled clinical trials.

[20]  D. Gillen,et al.  Frequentist evaluation of group sequential clinical trial designs , 2007, Statistics in medicine.

[21]  A. Rukhin.  Bayes and Empirical Bayes Methods for Data Analysis , 1997 .

[22]  Mkb Parmar,et al.  Bayesian data monitoring in clinical trials , 1997 .