Comparison of Bayesian and frequentist group-sequential clinical trial designs

Frequentist evaluation of group sequential clinical trial designs.

Group sequential stopping rules are often used as guidelines in the monitoring of clinical trials in order to address the ethical and efficiency issues inherent in human testing of a new treatment or preventive agent for disease. Such stopping rules have been proposed based on a variety of different criteria, both scientific (e.g. estimates of treatment effect) and statistical (e.g. frequentist...

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 design...

Group sequential designs for clinical trials.

Frequentist and Bayesian Interim Analysis in Clinical Trials: Group Sequential Testing and Posterior Predictive Probability Monitoring Using SAS

In a fixed-sample clinical trial, data collected from all individuals are analyzed at the end of the trial. In contrast, an interim analysis conducts data analysis before the completion of data collection. An interim analysis in clinical trials provides advantages over a fixed-sample clinical trial. An interim analysis can effectively terminate a trial early for efficacy, futility or safety iss...

Adaptive Designs for Group Sequential Clinical Survival Experiments

Randomized two-group clinical survival experiments now commonly allow at least one interim look, enabling possible early stopping to meet ethical concerns. Various authors have also studied the possibility of interim design modifications to adapt to unexpected accrual or control-group mortality rates. This paper formulates trial design as a decision theoretic problem with a finite number of int...