Format

Send to

Choose Destination
Clin Trials. 2016 Feb;13(1):31-8. doi: 10.1177/1740774515617740. Epub 2016 Jan 14.

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

Author information

1
Department of Mathematics and Statistics, Fylde College, Lancaster University, Lancaster, UK j.whitehead@lancaster.ac.uk.
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.
3
Centre for Tropical Medicine and Global Health, Nuffield Department of Clinical Medicine, University of Oxford, Oxford, UK.

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.

KEYWORDS:

Ebola; infectious disease; multi-stage approach; sequential design; single-arm design; stopping rule

PMID:
26768556
PMCID:
PMC5856305
DOI:
10.1177/1740774515617740
[Indexed for MEDLINE]
Free PMC Article

Supplemental Content

Full text links

Icon for Atypon Icon for PubMed Central
Loading ...
Support Center