Frequentist evaluation of 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.

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...

Exact inference for adaptive group sequential designs.

Methods for controlling the type-1 error of an adaptive group sequential trial were developed in seminal papers by Cui, Hung, and Wang (Biometrics, 1999), Lehmacher and Wassmer (Biometrics, 1999), and Müller and Schäfer (Biometrics, 2001). However, corresponding solutions for the equally important and related problem of parameter estimation at the end of the adaptive trial have not been complet...