How should clinical trials be executed during a crisis such as an epidemic? Which aspects, if any, of the clinical trial process will change? Who needs to be involved and when do people need to act to ensure efficient management of the research? The National Academies of Sciences, Engineering, and Medicine (NASEM) turned to the 2014 Ebola epidemic as a case study to answer these questions and others.
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 (FDA) tasked NASEM to analyze clinical trials conducted in West Africa during the Ebola epidemic. Upon completing their analysis, NASEM recommended ways to improve and accelerate clinical trial research during future infectious disease outbreaks. The committee determined that randomized clinical 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.”1 Michelle Mancher, program officer for the NASEM report, explained that “during the Ebola outbreak, while the trial teams moved at lightning speeds, the trials started after the peak of the epidemic and were still too late… to be successful in the future, work will have to be done during and between outbreaks” during in an Outsorcing-Pharma.com interview. The NASEM report covers three recommended focus areas: communication and community engagement, capacity strengthening, and internal coordination and collaboration.
The global community and CROs
Effectively responding to the next epidemic and preventing future epidemics will require a global effort. Healthcare providers, life science professionals, the at-risk population, and others all have roles to play. Contract research organizations (CROs) must participate as well. “During a future epidemic,” Mancher explains, “when time is of the essence, CROs 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.”1
Assuming clinical trials can be planned and coordinated efficiently and without delay after and during an outbreak is “unrealistic” according to Mancher. Work needs to be done in the interim, before and between epidemics, to ensure the best response can be administered quickly to reduce a disease’s impact on a given population.
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