Scientists around the world are racing to develop vaccines and treatments for the novel coronavirus in an effort to halt the global COVID-19 pandemic. While recognizing the need for speed, the scientific community is committed to ensuring these treatments are safe and effective through randomized clinical trials—the only proven path to that end.
However, during infectious disease outbreaks, a clinical trial, by design, can have drawbacks that may stand in the way of generating reliable evidence. As trials for COVID-19 treatments, like the drug Remdesivir, are already underway, researchers are hoping to avoid mistakes made during the West African Ebola epidemic, in which incomplete studies led to inconclusive results.
To that end, in a new paper published in the New England Journal of Medicine (NEJM), public health experts call for the implementation of a new kind of model during such epidemics: a so-called “core protocol,” which would allow a single clinical trial to extend across multiple infectious disease outbreaks.
“The idea is that a trial might start as soon as possible once an outbreak was underway, but if the outbreak tailed off before enough information was collected, the data would be stored, rather than reported, and the trial would continue the next time another outbreak appeared,” explains co-author Susan Ellenberg, interim chair of Biostatistics, Epidemiology, and Informatics at the Perelman School of Medicine.
As members of the World Health Organization’s Research and Development Blueprint Working Group on Clinical Trials, Ellenberg and colleagues from around the world are tasked with addressing approaches to testing new therapies and vaccines in the context of infectious disease outbreaks. The authors did not specifically write the NEJM paper in the context of COVID-19, but Ellenberg said that a core protocol could and should be applied to clinical trials conducted during this pandemic.
Read more at Penn Medicine News.
