Regulatory and Operational Complexities of Conducting a Clinical Treatment Trial During an Ebola Virus Disease Epidemic.
case_series · Level IV
Where this comes from
- Record sourced from PubMed, PMID 29206908.
- Also identified by DOI 10.1093/cid/cix1061 and PMC identifier 5905621.
- Licence recorded as CC BY.
- The licence permits redistribution, so the abstract is shown in full and the full text is available from the publisher.
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.
Medical subject headings
- Biomedical Research
- Clinical Trials, Phase II as Topic
- Epidemics
- Hemorrhagic Fever, Ebola
- RNA, Small Interfering