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Designs for adding a treatment arm to an ongoing clinical trial

Bennett, Maxine and Mander, Adrian P. 2020. Designs for adding a treatment arm to an ongoing clinical trial. Trials 21 (1) , 251. 10.1186/s13063-020-4073-1

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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.

Item Type: Article
Date Type: Publication
Status: Published
Schools: Medicine
Publisher: BioMed Central
ISSN: 1745-6215
Date of First Compliant Deposit: 29 April 2021
Date of Acceptance: 13 January 2020
Last Modified: 29 Apr 2021 14:45

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