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

Stallard, N. and Hampson, L. and Benda, N. and Brannath, W. and Burnett, T. and Friede, T. and Kimani, P.K. and Koenig, F. and Krisam, J. and Mozgunov, P. and Posch, M. and Wason, J. and Wassmer, G. and Whitehead, J. and Williamson, S.F. and Zohar, S. and Jaki, T. (2020) Efficient Adaptive Designs for Clinical Trials of Interventions for COVID-19. Statistics in Biopharmaceutical Research, 12 (4). pp. 483-497. ISSN 1946-6315

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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.

Item Type:
Journal Article
Journal or Publication Title:
Statistics in Biopharmaceutical Research
Uncontrolled Keywords:
/dk/atira/pure/subjectarea/asjc/3000/3003
Subjects:
ID Code:
146537
Deposited By:
Deposited On:
25 Aug 2020 14:05
Refereed?:
Yes
Published?:
Published
Last Modified:
03 Dec 2020 06:39