Sample size re-estimation for pivotal clinical trials

It is well known that if the hypothesis test is left unchanged, the Type I error rate may be inflated for sample size re-estimation (SSR) designs. To address this issue, three main approaches have been proposed in the literature: combination test, conditional error and conventional test with sample size increase in the allowable region (AR) only. These three seemingly different approaches are in fact connected. For each combination test, there is a corresponding conditional error function and AR.

Source: Contemporary Clinical Trials - November 17, 2020 Category: Radiology Authors: Yi Liu, Heng Xu Source Type: research