Trial design for evaluating novel treatments during an outbreak of an infectious disease

Clinical Trials : Journal of the Society for Clinical Trials
John WhiteheadPeter Horby

Abstract

Tragically, the outbreak of Ebola that started in West Africa in 2014 has been far more extensive and damaging than any previous outbreaks. The duration of the outbreak has, for the first time, allowed the clinical evaluation of Ebola treatments. This article discusses the designs used for two such clinical trials which have recruited patients in Liberia and Sierra Leone. General principles are outlined for trial designs intended to be deployed quickly, adapt flexibly and provide results soon enough to influence the course of the current epidemic rather than just providing evidence for use should Ebola break out again. Lessons are drawn for the conduct of clinical research in future outbreaks of infectious diseases, where the sequence of events may or may not be similar to the West African Ebola epidemic.

References

Apr 1, 1992·Controlled Clinical Trials·J Whitehead
Dec 12, 2007·Statistics in Medicine·John WhiteheadGordon Graham
Dec 21, 2010·Statistics in Medicine·Gordana Jovic, John Whitehead
Jun 25, 2014·Statistics in Medicine·Lisa V HampsonPaul Brogan
Sep 23, 2014·The New England Journal of Medicine·UNKNOWN WHO Ebola Response TeamZabulon Yoti

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Citations

Oct 13, 2016·The New England Journal of Medicine·UNKNOWN PREVAIL II Writing GroupDenis Malvy
Nov 28, 2017·Clinical Infectious Diseases : an Official Publication of the Infectious Diseases Society of America·Susan S EllenbergKeith P W J McAdam
May 4, 2016·Clinical Trials : Journal of the Society for Clinical Trials·Michael A Proschan, Lori E Dodd
May 6, 2016·Clinical Trials : Journal of the Society for Clinical Trials·John Whitehead
Aug 31, 2016·Journal of Medical Ethics·Philippe Calain

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