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Clin Infect Dis. 2018 Apr 17;66(9):1454-1457. doi: 10.1093/cid/cix1061.

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

Author information

1
Epidemic Diseases Research Group Oxford (ERGO), Centre for Tropical Medicine and Global Health, University of Oxford, United Kingdom.
2
International Severe Acute Respiratory and Emerging Infection Consortium, Nuffield Department of Medicine, University of Oxford, United Kingdom.
3
Interdepartmental Division of Critical Care Medicine, Department of Medicine, University of Toronto, Ontario, Canada.
4
GOAL Global, Dun Laoghaire, Ireland.
5
Military 34 Hospital, Republic of Sierra Leone Armed Forces and College of Medicine and Allied Health Sciences, Freetown.
6
Centre for Tropical Medicine and Global Health, Nuffield Department of Medicine, University of Oxford, United Kingdom.
7
Special Programme for Research and Training in Tropical Diseases (TDR), World Health Organization, Geneva, Switzerland.

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.

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