Abstract
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.
Highlights
Ebola virus disease (EVD)–specific treatments were proposed as a method to improve patient survival and curb further escalation of the West Africa (2013–2016) epidemic
Subsequent reports lauded the trials as “ground-breaking” [1], and criticized the paucity of definitive findings and the continued lack of licensed therapies [1, 2]. They advise that improving the ability to conduct analogous trials rapidly is a high priority in preparing for future epidemics [1, 3]
Two RAPIDE trials enrolled patients [5, 6], including the trial discussed here—a phase II clinical trial of the small interfering RNA lipid nanoparticle product TKM-130803 conducted in the GOAL Global Ebola Treatment Centre (ETC) in Sierra Leone
Summary
Ebola virus disease (EVD)–specific treatments were proposed as a method to improve patient survival and curb further escalation of the West Africa (2013–2016) epidemic. The clinical trials undertaken to assess the most promising agents were unprecedented. Subsequent reports lauded the trials as “ground-breaking” [1], and criticized the paucity of definitive findings and the continued lack of licensed therapies [1, 2]. They advise that improving the ability to conduct analogous trials rapidly is a high priority in preparing for future epidemics [1, 3]. We report details for one such clinical trial
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