Non-randomised Ebola trials-lessons for optimal outbreak research

Ippolito, Giuseppe, Lanini, Simone, Brouqui, Philippe, Di Caro, Antonino, Vairo, Francesco, Fusco, Francesco Maria, Krishna, Sanjeev, Capobianchi, Maria Rosaria, Kyobe-Bosa, Henry, Puro, Vincenzo, Woelfel, Roman, Avsic-Zupanc, Tatjana, Ioannidis, John P. A., Portella, Gina, Kremsner, Peter, Dar, Osman, Bates, Matthew and Zumla, Alimuddin (2016) Non-randomised Ebola trials-lessons for optimal outbreak research. Lancet Infectious Diseases, 16 (4). pp. 407-408. ISSN 1473-3099

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Abstract

Peter William Horby and colleagues1,2 contest our views about the need for randomised clinical trials (RCT)3 and the missed opportunities for an effective Europe–Africa research framework4 during the recent Ebola virus disease outbreak in west Africa. In stating their case against the need for randomised studies, the authors quote Byar and colleagues5 as supporting the use of non-randomised designs. However, Byar and colleagues in fact do strongly support randomisation, and recommend randomisation even in phase 1 trials. They emphasise the pivotal role of randomisation, and suggest that in emerging infections, the use of non-randomised studies was justified only when five conditions were simultaneously met: (1) “there must be sufficient experience to ensure that the patients not receiving therapy will have a uniformly poor prognosis”; (2) “the therapy must not be expected to have substantial side-effects”; (3) “there must be a justifiable expectation that the potential benefit to the patient will be sufficiently large to make interpretation of a non-RCT unambiguous”; (4) “the scientific rationale for the treatment must be sufficiently strong that a positive result would be widely accepted”; and (5) “there must be no other treatment appropriate to use as a control”. As we have argued,3 these conditions were not met during the recent Ebola virus disease epidemic.

Keywords:Ebola
Subjects:A Medicine and Dentistry > A300 Clinical Medicine
Divisions:College of Science > School of Life Sciences
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ID Code:28355
Deposited On:08 Sep 2017 15:47

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