Corner cutting compromises clinical trials: the inherent problems with up-front randomisation and a common standard arm

Hills, Robert ORCID: https://orcid.org/0000-0003-0166-0062, Richards, S. M. and Wheatley, Keith 2003. Corner cutting compromises clinical trials: the inherent problems with up-front randomisation and a common standard arm. Leukemia Research 27 (12) , pp. 1071-1073. 10.1016/S0145-2126(03)00126-7

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Abstract

To minimise bias, clinical trials must be randomised, and all patients analysed by allocated treatment. With several separate randomisations, patients should be analysed only within the randomisation they entered, and not compared against patients in different randomisations. Some people worry that randomised trials result in many patients receiving an inferior treatment. Accordingly, several suggestions have been made, including a combined control arm for many trials, and performing several randomisations at the same up-front time point. These approaches fundamentally contradict the above statistical principles, and can lead to wrong conclusions. We explore these problems, with reference to one such recent proposal.

Item Type:	Article
Date Type:	Publication
Status:	Published
Schools:	Medicine
Subjects:	R Medicine > R Medicine (General)
Publisher:	Elsevier
ISSN:	0145-2126
Last Modified:	24 Oct 2022 11:54
URI:	https://orca.cardiff.ac.uk/id/eprint/49708

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