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

Authors
  • Whitehead, John1
  • Olliaro, Piero2
  • Lang, Trudie3
  • Horby, Peter3
  • 1 Department of Mathematics and Statistics, Fylde College, Lancaster University, Lancaster, UK [email protected]
  • 2 Centre for Tropical Medicine and Global Health, Nuffield Department of Clinical Medicine, University of Oxford, Oxford, UK UNICEF-UNDP-World Bank-WHO Special Programme for Research and Training in Tropical Diseases, Geneva, Switzerland. , (Switzerland)
  • 3 Centre for Tropical Medicine and Global Health, Nuffield Department of Clinical Medicine, University of Oxford, Oxford, UK.
Type
Published Article
Journal
Clinical trials (London, England)
Publication Date
Feb 01, 2016
Volume
13
Issue
1
Pages
31–38
Identifiers
DOI: 10.1177/1740774515617740
PMID: 26768556
Source
Medline
Keywords
License
Unknown

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.

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