Activity

Committee on Clinical Trials During the 2014-15 Ebola Outbreak


Type: Consensus Study
Topics: Biomedical and Health Research, Diseases, Ebola, Global Health, Public Health
Boards: Board on Global Health, Board on Health Sciences Policy

Activity Description

An ad hoc committee of the National Academies of Sciences, Engineering, and Medicine will review and conduct an analysis of the clinical trials conducted during the 2014-2015 Ebola virus disease (EVD) outbreak in West Africa. The final deliverable from this committee will be a consensus report that explores and analyzes the scientific and ethical issues related to clinical trial design, conduct, and reporting. Particular emphasis will be given to clinical trials for vaccine and therapeutic candidates for EVD conducted by the international community in settings where there is limited healthcare and research infrastructure.

 

In summary the report will:

  • Assess the scientific value of the different EVD vaccine and therapeutic clinical trials conducted in Liberia, Sierra Leone, and Guinea and the data derived from them.
  • Make recommendations for how, in the context of an international emerging or re-emerging infectious disease event, clinical trials can best be prioritized and conducted to (1) speed data collection; (2) inform clinical management of patients; (3) assess the safety, efficacy, and effectiveness of therapeutics and vaccines; and/or (4) improve/augment outbreak control efforts.
  • Address whether adjustments to scientific or ethical standards are appropriate in the conduct of research in outbreak settings, and if so, under what circumstances.
  • Identify opportunities for collaborative investment to achieve long-term ethical and scientific gains from clinical trials conducted during emerging infectious disease events.

The committee actively welcomes feedback from the public on this study. If you would like to give commentary on this project, please send your comments to evdclinicaltrials@nas.edu.

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