An independent ad hoc committee of the U.S. National Academy of Sciences, Engineering, and Medicine is conducting a review and analysis of the clinical trials conducted during the 2014—2015 Ebola Virus Disease (EVD) Outbreak in West Africa. The committee, co-chaired by Dr. Gerald T. Keusch and Dr. Keith McAdam, and comprised of a group of 16 distinguished individuals with diverse expertise from the U.S., Europe and Africa, was charged to explore the scientific and ethical issues related to clinical trials conducted in Liberia, Sierra Leone and Guinea between 2014—2015. The committee will develop a report that will inform guidelines and best practices for the design, conduct and reporting of clinical trials in response to a future outbreak. Particular emphasis is being 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.
The committee is hosting a workshop in London to hear from the individuals directly involved in Ebola clinical trials, as well as others with relevant experience and expertise, based in the UK and Europe. The committee will also host similar information gathering workshops in the US and West Africa. The London meeting aims to:
- Explore the design and implementation of clinical trials during the 2014-2015 Ebola outbreak.
- Examine the cultural, public health, and ethical context surrounding the respective designs of EVD clinical trials; highlight important takeaways for future trials in a similar emergency context.
- Discuss the scientific and public health gains from clinical trials during the EVD outbreak and identify lessons learned to improve a future international response to a public health emergency in a low-resourced country.
- Consider the role of the international bodies (governments, regulatory agencies, NGO’s, academicians, and others) in a rapid, robust, and sustained response.