Evaluating clinical trial designs for investigational treatments of Ebola virus disease.

ABSTRACT:

Background

Experimental treatments for Ebola virus disease (EVD) 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.

Methods and findings

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

SUBMITTER: Cooper BS 

PROVIDER: S-EPMC4397078 | biostudies-literature | 2015 Apr

REPOSITORIES: biostudies-literature