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Rigorous Clinical Trial Design in Public Health Emergencies Is Essential

Ellenberg, SS; Keusch, GT; Babiker, AG; Edwards, KM; Lewis, RJ; Lundgren, JD; Wells, CD; ... McAdam, KPWJ; + view all (2017) Rigorous Clinical Trial Design in Public Health Emergencies Is Essential. Clinical Infectious Diseases , 66 (9) pp. 1467-1469. 10.1093/cid/cix1032. Green open access

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Abstract

Randomized clinical trials are the most reliable approaches to evaluating the effects of new treatments and vaccines. During the 2014–2015 West African Ebola epidemic, many argued that such trials were neither ethical nor feasible in an environment of limited health infrastructure and severe disease with a high fatality rate. Consensus among the numerous organizations providing help to the affected areas was never achieved, resulting in fragmented collaboration, delayed study initiation, and ultimately failure to provide definitive evidence on the efficacy of treatments and vaccines. Randomized trials were in fact approved by local ethics boards and initiated, demonstrating that randomized trials, even in such difficult circumstances, are feasible. Improved planning and collaboration among research and humanitarian organizations, and affected communities, in the interepidemic periods are needed to ensure that questions regarding the efficacy of vaccines and treatments can be definitively answered during future public health emergencies.

Type: Article
Title: Rigorous Clinical Trial Design in Public Health Emergencies Is Essential
Open access status: An open access version is available from UCL Discovery
DOI: 10.1093/cid/cix1032
Publisher version: https://doi.org/10.1093/cid/cix1032
Language: English
Additional information: This version is the author accepted manuscript. For information on re-use, please refer to the publisher’s terms and conditions.
Keywords: Randomized clinical trial, Ebola, ethics
UCL classification: UCL
UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences
UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences > Faculty of Population Health Sciences
UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences > Faculty of Population Health Sciences > Inst of Clinical Trials and Methodology
UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences > Faculty of Population Health Sciences > Inst of Clinical Trials and Methodology > MRC Clinical Trials Unit at UCL
URI: https://discovery.ucl.ac.uk/id/eprint/10049929
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