Evaluating Clinical Trial Designs for Investigational Treatments of Ebola Virus Disease

PLOS MEDICINE   by Ben Cooper and others                                                             April 14, 2015
Experimental treatments for Ebola virus disease might reduce EVD mortality. There is uncertainty about the ability of different clinical trial designs to identify effective treatments, and about the feasibility of implementing individually randomised controlled trials during an Ebola epidemic

A treatment evaluation programme for use in EVD was devised using a multi-stage approach (MSA) with two or three stages, including both non-randomised and randomised elements. The probabilities of rightly or wrongly recommending the experimental treatment, the required sample size, and the consequences for epidemic outcomes over 100 d under two epidemic scenarios were compared for the MSA, a sequential randomised controlled trial (SRCT) with up to 20 interim analyses, and, as a reference case, a conventional randomised controlled trial (RCT) without interim analyses.

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http://journals.plos.org/plosmedicine/article?id=10.1371/journal.pmed.1001815