Regulatory and Operational Complexities of Conducting a Clinical Treatment Trial During an Ebola Virus Disease Epidemic.
- Resource Type
- Article
- Authors
- Rojek, Amanda M; Dunning, Jake; Leliogdowicz, Aleksandra; Castle, Lyndsey; Lieshout, Mary Van; Carson, Gail; Sahr, Foday; Olliaro, Piero; Horby, Peter W
- Source
- Clinical Infectious Diseases. 5/1/2018, Vol. 66 Issue 9, p1454-1457. 4p.
- Subject
- *CLINICAL trials
*EBOLA virus disease
*EPIDEMICS
*EXPERIMENTAL design
*MEDICAL research
*RULES
- Language
- ISSN
- 1058-4838
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. [ABSTRACT FROM AUTHOR]