Journal article

Performance of different clinical trial designs to evaluate treatments during an epidemic

Matthias Brueckner, Andrew Titman, Thomas Jaki, Amanda Rojek, Peter Horby

PLoS One | PUBLIC LIBRARY SCIENCE | Published : 2018

Abstract

In the 2013-2016 west Africa outbreak of Ebola Virus Disease (EVD), most of the planned clinical trials failed to reach a conclusion within the time frame of the epidemic. The performance of clinical trial designs for the evaluation of one or more experimental treatments in the specific context of an ongoing epidemic with changing case fatality rates (CFR) and unpredictable case numbers is unclear. We conduct a comprehensive evaluation of commonly used two- and multi-arm clinical trial designs based on real data, which was recorded during the 2013-16 EVD epidemic in west Africa. The primary endpoint is death within 14 days of hospitalization. The impact of the recruitment start times relativ..

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University of Melbourne Researchers

Grants

Awarded by Wellcome Trust of Great Britain


Awarded by Dr Jaki's Senior Research Fellowship


Funding Acknowledgements

MB and TJ are supported in part from Dr Jaki's Senior Research Fellowship (NIHR-SRF-2015-08-001) supported by the National Institute for Health Research (https://www.nihr.ac.uk). The views expressed in this publication are those of the authors and not necessarily those of the NHS, the National Institute for Health Research or the Department of Health. PH and AR are supported by the Wellcome Trust of Great Britain (grant number 106491/Z/14/Z) (https://wellcome.ac.uk/funding). The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript.This work is funded in part from Dr Jaki's Senior Research Fellowship (NIHR-SRF-2015-08-001) supported by the National Institute for Health Research. The views expressed in this publication are those of the authors and not necessarily those of the NHS, the National Institute for Health Research or the Department of Health. PH and AR are supported by the Wellcome Trust of Great Britain (grant number 106491/Z/14/Z).