Designing multi-arm multi-stage clinical trials using a risk-benefit criterion for treatment selection.

ABSTRACT: Multi-arm clinical trials that compare several active treatments to a common control have been proposed as an efficient means of making an informed decision about which of several treatments should be evaluated further in a confirmatory study. Additional efficiency is gained by incorporating interim analyses and, in particular, seamless Phase II/III designs have been the focus of recent research. Common to much of this work is the constraint that selection and formal testing should be based on a single efficacy endpoint, despite the fact that in practice, safety considerations will often play a central role in determining selection decisions. Here, we develop a multi-arm multi-stage design for a trial with an efficacy and safety endpoint. The safety endpoint is explicitly considered in the

SUBMITTER: Jaki T 

PROVIDER: S-EPMC4950037 | biostudies-literature | 2016 Feb

REPOSITORIES: biostudies-literature