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

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

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.

Publication types

  • Research Support, Non-U.S. Gov't

MeSH terms

  • Africa, Western / epidemiology
  • Biomedical Research / organization & administration*
  • Clinical Trials, Phase II as Topic*
  • Data Collection / methods
  • Disease Outbreaks
  • Epidemics*
  • Hemorrhagic Fever, Ebola / drug therapy*
  • Hemorrhagic Fever, Ebola / epidemiology
  • Humans
  • Informed Consent
  • Monitoring, Physiologic
  • RNA, Small Interfering / therapeutic use*
  • Research Design
  • Sierra Leone / epidemiology

Substances

  • RNA, Small Interfering
  • TKM-130803