Regulatory and Operational Complexities of Conducting a Clinical Treatment Trial During an Ebola Virus Disease Epidemic
Amanda M Rojek, Jake Dunning, Aleksandra Leliogdowicz, Lyndsey Castle, Mary Van Lieshout, Gail Carson, Foday Sahr, Piero Olliaro, Peter W Horby
Clinical Infectious Diseases | OXFORD UNIV PRESS INC | Published : 2018
The first phase II and III clinical trials for Ebola virus disease treatments were conducted during the West Africa outbreak. We report the operational practicalities of conducting a phase II clinical trial of TKM-130803 to international standards during this outbreak.
Awarded by Wellcome Trust of Great Britain
Awarded by EU FP7 project PREPARE
This work was supported by the Wellcome Trust of Great Britain (grant 106491/Z/14/Z and 089275/Z/09/Z) and by the EU FP7 project PREPARE (grant 602525). A. M. R. is funded by a Rhodes Scholarship.