Common threads between sample size recalculation and group sequential procedures

Sample size recalculation (SSR) methods ensure that a study closely achieves the required power by allowing for the original sample size to be modified through updating misspecified nuisance parameters. Some SSR procedures extend this concept by incorporating information on the estimated treatment difference as well. While group sequential methodology allows for early stopping of a study in the context of repeated hypothesis tests, SSR usually involves the extension of a study to accommodate misspecified design parameters. This work describes these methods and places them in a common framework. Copyright © 2003 John Wiley & Sons, Ltd.     

A review and re‐interpretation of a group‐sequential approach to sample size re‐estimation in two‐stage trials

In this paper, we review the adaptive design methodology of Li et al. (Biostatistics 3 :277–287) for two‐stage trials with mid‐trial sample size adjustment. We argue that it is closer in principle to a group sequential design, in spite of its obvious adaptive element. Several extensions are proposed that aim to make it even more attractive and transparent alternative to a standard (fixed sample size) trial for funding bodies to consider. These enable a cap to be put on the maximum sample size and for the trial data to be analysed using standard methods at its conclusion. The regulatory view of trials incorporating unblinded sample size re‐estimation is also discussed. © 2014 The Authors. Pharmaceutical Statistics published by John Wiley & Sons, Ltd.