Clinical Trials of Therapeutics for the Prevention of Congenital Zika Virus Disease: Challenges and Potential Solutionsby Alex Salam, Amanda Rojek, Jake Dunning, Peter Horby
This article evaluates the major challenges in choosing therapeutics to prevent congenital ZIKV disease and conducting clinical trials of these treatments, with a focus on preventing congenital central nervous system malformations. This article was first published in Annals of Internal Medicine.
This paper proposes a generic ordinal sequential trial design (GOST) for a randomised clinical trial comparing an experimental treatment for an emerging infectious disease with standard care. The design is intended as an off-the-shelf, ready-to-use robust and flexible option. This article was first published in PLOS.
With video. Results of the Wellcome Trust funded trial of the experimental anti-Ebola drug TKM-130803 have been published in PLoS Medicine. Using a novel approach designed to get rapid indications of a drug’s effectiveness, the trial showed that at the dose given the drug did not improve survival compared to historic controls.