Infectious Diseases / Public Health

Clinical Research in Times of Ebola… and other Epidemics

As the news trickles in about the raging cholera outbreak in Yemen, and an emerging outbreak is being dealt with urgently in North-Eastern Nigeria, we are more frequently being confronted with the uncomfortable question of leveraging these situations to conduct clinical research activities. The National Academies of Science, Engineering and Medicine (NASEM) have come out with a report dealing with exactly this quandary. This report, aptly titled, “Integrating Clinical Research into Epidemic Response: The Ebola Experience”, deals with this ethically challenging issue. In the blurb to this report, the authors succinctly hint at the importance of this publication:

The 2014 Ebola epidemic in western Africa was the longest and deadliest Ebola outbreak in history, resulting in 28,616 cases and 11,310 deaths. In the midst of the rapidly spreading, highly dangerous contagious disease—with no Ebola-specific vaccines or therapeutics available to help curb the epidemic—the international community implemented clinical trials on investigational agents, not yet studied in humans for safety or efficacy. Within that context, the Office of the Assistant Secretary for Preparedness and Response, the National Institute of Allergy and Infectious Disease, and the U.S. Food and Drug Administration, supported the National Academies of Sciences, Engineering, and Medicine to convene a committee to analyze the clinical trials that were conducted during the epidemic and consider the many scientific, ethical and practical issues related to the conduct of research in similar contexts. The resulting report, Integrating Clinical Research into Epidemic Response: The Ebola Experience, assesses the value of the trials and makes recommendations about how the conduct of trials could be improved in the context of a future international emerging or re-emerging infectious disease event.

The NASEM have further outlined a set of recommendations based on their Ebola experience. The highlights of these include:

RECOMMENDATION 1:
Support the development of sustainable health systems and research capacities—Inter-epidemic

RECOMMENDATION 2
A. Develop memoranda of understanding to facilitate data collection and sharing—Inter-epidemic
B. Provide resources to enable data collection and sharing—Epidemic

RECOMMENDATION 3
Facilitate capacity for rapid ethics reviews and legal agreements—Inter-epidemic

RECOMMENDATION 4
Ensure that capacity-strengthening efforts bene t the local population—Epidemic

RECOMMENDATION 5
Enable the incorporation of research into national health systems—Inter-epidemic

RECOMMENDATION 6
A. Prioritize community engagement in research and response—Epidemic
B. Fund training and research into community engagement and communication for research and response—Inter-epidemic

RECOMMENDATION 7
A. Coordinate international efforts in research and development for infectious disease pathogens—Inter-epidemic
B. Establish and implement a cooperative international clinical research agenda—Epidemic

 

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