In a special issue on Ebola for the journal Clinical Trials, leading researchers from across the globe, including from the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH), describe in a series of articles the challenges of conducting ethically and scientifically sound clinical research during the 2014-2015 Ebola outbreak in West Africa and lessons learned for future outbreaks. Lori E. Dodd, Ph.D., mathematical statistician in NIAID’s Division of Clinical Research, conceived of and edited the issue, which highlights different approaches to trial design and various viewpoints from the individuals and organizations who contributed to research efforts. Ultimately, the issue aims to foster discussion on how to proceed with research during the next inevitable outbreak.
In a perspective piece, authors NIAID Director Anthony S. Fauci, M.D., H. Clifford Lane, M.D., NIAID deputy director for clinical research and special projects, and Hilary D. Marston, M.D., M.P.H., NIAID medical officer and policy advisor for global health, draw on lessons learned from the early years of the HIV/AIDS pandemic and the recent Ebola outbreak. They outline a set of core clinical research principles—including collaborating with local partners, prioritizing candidate treatments and vaccines with plausible benefit, and promoting transparency through prompt dissemination of results—that can help ensure studies meet the highest scientific standards and mitigate any potential harm to participants.
Additional articles authored by NIAID researchers and their colleagues discuss the statistical considerations and design of various Ebola vaccine trials as well as NIAID’s clinical trial of investigational Ebola treatments. Specifically, the articles examine the advantages and drawbacks of three separate investigational Ebola vaccine clinical trials initiated in West Africa, as well as the measures taken by the study teams to overcome challenges. In one example, the joint Liberia-U.S. team of investigators leading the vaccine trial known as PREVAIL I, or the Partnership for Research on Ebola Virus in Liberia, describe how they instituted a procedure of following up with newly vaccinated participants via phone to debunk rumors that the vaccines could cause Ebola virus infection. NIAID researchers also describe an unconventional, flexible trial design used to test candidate Ebola treatments, including ZMapp, in an outbreak setting.
- H. Lane et al. Conducting Clinical Trials in Outbreak Settings: Points to Consider. Clinical Trials DOI: 10.1177/1740774515618198 (2016)
- S. Kennedy et al. Implementation of an Ebola Virus Disease (EVD) Vaccine Clinical Trial During the Ebola Epidemic in Liberia: Procedures & Challenges. Clinical Trials DOI: 10.1177/1740774515621037 (2016).
- M. Proschan et al. Statistical Considerations for a Trial of Ebola Virus Disease Therapeutics. Clinical Trials DOI: 10.1177/1740774515620145 (2016).
- M Nason. Statistics and logistics: Design of Ebola Vaccine Trials in West Africa. Clinical Trials DOI: 10.1177/1740774515620612 (2016).
NIAID Director Anthony S. Fauci, M.D., and H. Clifford Lane, M.D., NIAID’s deputy director for clinical research and special projects, are available to comment on the series of articles.