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Efficient Adaptive Designs for Clinical Trials of Interventions for COVID-19.

Accepted version
Peer-reviewed

Type

Article

Change log

Authors

Stallard, Nigel 
Hampson, Lisa 
Benda, Norbert 
Brannath, Werner 
Burnett, Thomas 

Abstract

The COVID-19 pandemic has led to an unprecedented response in terms of clinical research activity. An important part of this research has been focused on randomized controlled clinical trials to evaluate potential therapies for COVID-19. The results from this research need to be obtained as rapidly as possible. This presents a number of challenges associated with considerable uncertainty over the natural history of the disease and the number and characteristics of patients affected, and the emergence of new potential therapies. These challenges make adaptive designs for clinical trials a particularly attractive option. Such designs allow a trial to be modified on the basis of interim analysis data or stopped as soon as sufficiently strong evidence has been observed to answer the research question, without compromising the trial's scientific validity or integrity. In this article, we describe some of the adaptive design approaches that are available and discuss particular issues and challenges associated with their use in the pandemic setting. Our discussion is illustrated by details of four ongoing COVID-19 trials that have used adaptive designs.

Description

Keywords

Adaptive trial, Group sequential design, Multi-arm multi-stage, Pandemic research, Platform trial, SARS-CoV-2

Journal Title

Stat Biopharm Res

Conference Name

Journal ISSN

1946-6315
1946-6315

Volume Title

12

Publisher

Informa UK Limited

Rights

All rights reserved
Sponsorship
Medical Research Council (MR/N028171/1)
NIHR Academy (SRF-2015-08-001)
Medical Research Council (MC_UU_00002/14)