On Bayesian Sequential Clinical Trial Designs

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...

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 clinical trial designs: Another option for trauma trials?

Conducting clinical trials in trauma care is challenging. As new treatments become available, we are faced with the dilemma of how to confirm their effectiveness, and strengthen the evidence base. Randomized controlled trials are the gold standard, but target groups in trauma care are often small and specialized, making the classical approach to trial design difficult. Bayesian designs represen...

A Bayesian Randomized Clinical Trial: A Decision Theoretic Sequential Design

We propose a Bayesian decision theoretic framework for randomization in clinical trials. The proposed approach reconciles the apparent contradiction between the practice of clinical trial design and implications of a traditional decision theoretic setup. Although it is universal practice to use randomization in clinical trial design, a standard decision theoretic setup does not justify randomiz...

Group sequential designs for clinical trials.