Group sequential designs for negative binomial outcomes

Group sequential designs for clinical trials.

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...

Exact Group Sequential Methods for Estimating a Binomial Proportion

�e �rst review existing sequential methods for estimating a binomial proportion. A�erward, we propose a new family of group sequential sampling schemes for estimating a binomial proportion with prescribed margin of error and con�dence level. In particular, we establish the uniform controllability of coverage probability and the asymptotic optimality for such a family of sampling schemes. Our th...

Issues in Group Sequential/Adaptive Designs

In recent years, there has been great interest in the use of adaptive features in clinical trials (i.e., changes in design or analyses guided by examination of the accumulated data at an interim point in the trial) that may make the studies more efficient (e.g., shorter duration, fewer patients). Many statistical methods have been developed to maintain the validity of study results when adaptiv...

From Group Sequential to Adaptive Designs