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Regulatory and Operational Complexities of Conducting a Clinical Treatment Trial During an Ebola Virus Disease Epidemic.


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.

SUBMITTER: Rojek AM 

PROVIDER: S-EPMC5905621 | biostudies-literature | 2018 Apr

REPOSITORIES: biostudies-literature

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Regulatory and Operational Complexities of Conducting a Clinical Treatment Trial During an Ebola Virus Disease Epidemic.

Rojek Amanda M AM   Dunning Jake J   Leliogdowicz Aleksandra A   Castle Lyndsey L   Van Lieshout Mary M   Carson Gail G   Sahr Foday F   Olliaro Piero P   Horby Peter W PW  

Clinical infectious diseases : an official publication of the Infectious Diseases Society of America 20180401 9


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. ...[more]

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