In October 2015, the Office of the Assistant Secretary for Preparedness and Response, the National Institute of Allergy and Infectious Disease, and the US Food and Drug Administration asked the National Academies of Sciences, Engineering, and Medicine to review and analyze clinical trials conducted in West Africa during the 2014 Ebola epidemic.
From this analysis, a committee was tasked with recommending ways to improve and accelerate clinical research during future infectious disease outbreaks.
The committee determined that randomized controlled trials (RCTs) are “both ethical and preferable in the context of an epidemic as RCTs provide the fastest way to identify beneficial treatments and vaccines while minimizing risk,” Michelle Mancher, program officer for the report, told Outsourcing-Pharma.com.
“During the Ebola outbreak, while the trial teams moved at lightning speed, the trials started after the peak of the epidemic and were still too late,” said Mancher. “To be successful in the future, work will have to be done during and between outbreaks.”
The report focuses on three categories, including communication and community engagement, capacity strengthening, and international coordination and collaboration.
Mancher explained, “The mobilization of a rapid and robust research response during the next epidemic will depend not just on what happens during the epidemic, but on what happens before or between epidemics.”
The global community can be best prepared if it works collaboratively to coordinate a research agenda –including input from the at-risk population.
Contract research organizations (CROs) also have a role, as Mancher said, “During a future epidemic, when time is of the essence, CRO’s can play critical logistical support roles for clinical trial teams.”
For example, to immediately address the technical or infrastructure demands, including establishing contracts to secure clinical monitoring, safety monitoring, data management, and cold chain assistance.”
Running a clinical trial during an epidemic
During the Ebola epidemic – which was the longest and most deadly Ebola epidemic in history, according to the report – researchers had to overcome “immense” obstacles while designing and implementing trials in West Africa, Mancher said.
These challenges included limited health research infrastructure and workforce, tension between patient care and research priorities, in addition to the presence of fear, rumors, and lack of trust among the local communities.
“The Committee learned that an emergency context heightens the need to engage local communities and coordinate with national authorities and other research and response teams,” explained Mancher, adding that clinical trials conducted during a future epidemic will likely face similar challenges.
“It is critical that the core scientific and ethical requirements that govern all research on human subjects are upheld during emergency contexts, but since the timeline will likely need to be compressed, researchers will need to find faster ways for accomplishing steps if they hope to launch trials before an epidemic wanes,” she added.
Ultimately, Mancher said it is “unrealistic” to assume clinical trials can be planned and coordinated efficiently and without delay, after an outbreak begins and while it’s ongoing.
“Activities that build relationships and address foreseeable problems in implementing a research program—such as determining how to evaluate competing trial proposals, deciding what should be included in clinical trial contracts, and educating national researchers and review boards in study conduct—must begin in the inter-epidemic period,” she concluded.
National Academies of Sciences, Engineering, and Medicine. 2017
Integrating Clinical Research into Epidemic Response: The Ebola Experience
Washington, DC: The National Academies Press