Designs for adding a treatment arm to an ongoing clinical trial

Bennett, Maxine and Mander, Adrian P. ORCID: https://orcid.org/0000-0002-0742-9040 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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Abstract

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:	Schools > Medicine
Publisher:	BioMed Central
ISSN:	1745-6215
Date of First Compliant Deposit:	29 April 2021
Date of Acceptance:	13 January 2020
Last Modified:	04 May 2023 23:32
URI:	https://orca.cardiff.ac.uk/id/eprint/140822

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