A group of scientists, including Thomas Fleming, a professor of biostatistics at the University of Washington School of Public Health, has developed a new approach for clinical trials during infectious disease outbreaks such as the coronavirus disease 2019 (COVID-19) pandemic.
Their approach — outlined in an article published April 1 in the New England Journal of Medicine — could reduce the barriers researchers are confronted with when testing vaccines and treatments during an epidemic. The group is sponsored by the World Health Organization (WHO) and tasked with establishing a work plan for the design of clinical trials during public health emergencies.
In order to determine the efficacy of potential vaccines and therapies, it is important for clinical trials to be conducted during these emergencies. However, characteristics of infectious disease outbreaks are unpredictable; they range in size, emerge in different locations, can occur months or years apart, and may not last long enough for researchers to design and conduct clinical trials that yield conclusive results.
The new WHO core protocol concept allows clinical trials to extend across multiple infectious disease outbreaks. Instead of starting new independent trials for each successive outbreak, study teams can collaborate on existing, ongoing protocols. This consistency in protocol allows data from many sites and different outbreaks to be merged into one clinical trial.
Fleming notes that it was work conducted during the Ebola outbreaks that helped facilitate the idea of a core protocol. During the Ebola outbreak in the Democratic Republic of the Congo, Fleming chaired a committee for a WHO program that monitored emergency use of unregistered and investigational treatments.
“The scientific and ethical insights from the Ebola Virus Disease experiences are now being used by the WHO R&D Working Group to develop scientific processes to evaluate prevention and treatment interventions to address the current outbreak of the novel coronavirus,” Fleming says. Authoring core protocols for COVID-19 vaccine and treatment trials is one such intervention.
In addition to bringing multiple outbreaks under a unified clinical trial umbrella, the article notes that core protocols can alleviate the pressure to release inconclusive results from clinical trials, a practice that can make it more difficult to determine the effectiveness and safety of interventions.