November 16, 2020

Researchers from the UNC Gillings School of Global Public Health and the UNC School of Medicine have received funding from the Patient-Centered Outcomes Research Institute (PCORI) to compare how participants in COVID-19 clinical trials differ from real-world patients infected with the virus.

Randomized controlled trials (RCTs) are considered most appropriate for assessing the efficacy of treatment, but during pandemics like COVID-19, admitting participants in such trials can be a challenge. Because of the high variance in outcomes for patients infected with COVID-19 based on age, sex, ethnicity and existing comorbidities, RCTs often have difficulty enrolling a cohort of participants that precisely reflect real-world populations. Potential participants who are at highest risk from COVID-19 may not be willing to be randomized for treatment, especially when other treatment options are available through compassionate use.

Dr. Michael Webster-Clark

Dr. Michael Webster-Clark

Dr. Jennifer Lund

Dr. Jennifer Lund

The research team, led by Michael Webster-Clark, PharmD, PhD postdoctoral research associate, and Jennifer Lund, PhD, associate professor of epidemiology, is using the PCORI funding to leverage visualization tools to report differences in characteristics between RCT participants and real-world COVID-19 patients. They will also use the visualizations to assess how both trial and real-world groups change over time as the pandemic spreads.

“When studying treatments for any disease, be it COVID-19 or hypertension, it’s important to consider how well studies can estimate treatment effects in the populations most heavily impacted by the condition,” says Webster-Clark. “We hope that our visualizations will shed light on the kinds of patients that have been passed over for participation in COVID-19 related RCTs as well as the extent to which they may experience different clinical outcomes. This work should also give researchers a better sense of groups that may warrant further study and inform enrollment strategies during future pandemics.”

Webster-Clark and Lund will be supported by experts from the UNC School of Medicine and colleagues from the Gillings School’s Department of Epidemiology, including Til Stürmer, MD, PhD, MPH, Nancy A. Dreyer Distinguished Professor and chair of epidemiology; Alexander Keil, PhD, assistant professor of epidemiology; and Daniel Westreich, PhD, MSPH, associate professor of epidemiology. Joyce Pak, an epidemiology doctoral student, will also be assisting with the project.

The study is currently in progress, with the first batch of published trials pulled for review by the study team, and is expected to conclude in August 2021.

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