Power gains by using external information in clinical trials are typically not possible when requiring strict type I error control.

ABSTRACT: In the era of precision medicine, novel designs are developed to deal with flexible clinical trials that incorporate many treatment strategies for multiple diseases in one trial setting. This situation often leads to small sample sizes in disease-treatment combinations and has fostered the discussion about the benefits of borrowing of external or historical information for decision-making in these trials. Several methods have been proposed that dynamically discount the amount of information borrowed from historical data based on the conformity between historical and current data. Specifically, Bayesian methods have been recommended and numerous investigations have been performed to characterize the properties of the various borrowing mechanisms with respect to the gain to be expected in th

SUBMITTER: Kopp-Schneider A 

PROVIDER: S-EPMC7079072 | biostudies-literature | 2020 Mar

REPOSITORIES: biostudies-literature