Designs for adding a treatment arm to an ongoing clinical trial.

ABSTRACT:

Background

For many disease areas, there are often treatments in different stages of the development process. We consider the design of a two-arm parallel group trial where it is planned to add a new experimental treatment arm during the trial. This could potentially save money, patients, time and resources; however, the addition of a treatment arm creates a multiple comparison problem. Current practice in trials when a new treatment arm has been added is to compare the new treatment only to controls randomised concurrently, and this is the setting we consider here. Furthermore, for standard multi-arm trials, optimal allocation randomises a larger number of patients to the control arm than to each experimental treatment arm.

Methods

In this paper we propose an adaptive desig

SUBMITTER: Bennett M 

PROVIDER: S-EPMC7060622 | biostudies-literature | 2020 Mar

REPOSITORIES: biostudies-literature