Statement on Representativeness in Clinical Trials

Dean Melina Kibbe, MD

I write to share the School of Medicine’s Statement on Representativeness in Clinical Trials that was so thoughtfully written by the Clinical Research Advisory Committee led by James P. Nataro, MD, PhD, MBA, professor and chair of the Department of Pediatrics. As School of Medicine researchers engage in clinical research to learn about disease and better manage patient care, the subjects of clinical trials should be a diverse representation of the population. Our mission statement at UVA says we are “transforming health and inspiring hope for all Virginians and beyond” and addressing the issue of representativeness in clinical trials will support our achievement of this mission. I sincerely thank Dr. Nataro and the Clinical Research Advisory Committee for creating a statement that will serve as a guide for all clinical investigators as we strive to expand and improve clinical research at UVA.

The objective of all clinical research is to change how we think about disease or how we manage our patients. For observations made in research to be valid to broad population, the subjects in the clinical trial need to be representative of the population. Clinical trials are often challenged to enroll a panel of patients truly representative of the American population. Participation in clinical trials for people who are African-American, Hispanic, rural, and older is proportionally lower than people of other groups. Underrepresentation in clinical trials is a threat to the external validity of the data.

While many investigators and institutions have striven to improve the representation of subject populations, there has been little formal pressure to do so. This may be about to change. In October 2021 the New England Journal of Medicine published a seminal editorial (1), with accompanying video message (2), emphasizing the importance of representativeness. Moreover, as of January 1, 2022, the Journal has required all manuscripts describing clinical trials to include a table illustrating how their subject population represents the distribution of disease in the general patient population. There is no doubt other journals will soon follow suit. When study sections will begin to require descriptions of representativeness is unknown, but clearly the strength of a grant application will be improved if the investigator can attest to a representative subject population.

As we endeavor to grow and improve the quality of clinical research at UVA, it is necessary to address the issue of representativeness. iTHRIV can assist in this area. The iTHRIV portal page, Resources to Improve Representativeness in Research Studies, features a compendium of resources for clinical investigators to improve the representativeness of their subject populations. These include articles, tutorials, and links to resources, including financial ones. We strongly encourage our community of clinical investigators to embrace representativeness of their subject populations as a way to enhance external validity of their findings and to improve the quality of research in our School of Medicine, and our academic/community partners. If you are a clinical investigator please visit the iTHRIV portal to learn what resources are available.

Striving for Diversity in Research Studies. October 7, 2021. N Engl J Med 2021; 385:1429-1430
https://www.nejm.org/doi/full/10.1056/NEJMe2114651
www.ithriv.org
https://portal.ithriv.org/#/resource/1655

Members of the Clinical Research Advisory Committee

Gregory Townsend, MD, Associate Dean of Diversity, School of Medicine, University of Virginia
Laurie Archbald-Pannone, MD, MPH, Director of the Division of Geriatrics, School of Medicine, University of Virginia
Max Luna, MD, Associate Professor of Cardiology and Director of the Latino Health Initiative, School of Medicine, University of Virginia
Randy Jones, PhD, RN, FAAN, Professor, School of Nursing, University of Virginia
Gerald Teague, MD, Professor of Pediatrics, Associate Director of Child Health Research Center, School of Medicine, University of Virginia
James Nataro, MD, PhD, MBA, Professor and Chair of the Department of Pediatrics, School of Medicine, University of Virginia
Jennifer Phillips, RN, CCRC, Clinical & Translational Research Studies Manager, University of Virginia
Kristin Miller, iTHRIV Partnership Manager, University of Virginia
Lori Elder, RN, BSN, CCRA, Director of the Clinical Trials Office, School of Medicine, University of Virginia
Emily Wells, Research Program Manager, University of Virginia’s College at Wise
Stephanie DeLuca, PhD, Associate Professor of Pediatrics, Director of the Neuromotor Research Clinic, Virginia Tech
Kathy Hosig, PhD, MPH, RD, Director of the Virginia Tech Center for Public Health Practice and Research, Virginia Tech

Filed Under: Clinical, Dean's Message, Diversity, Equity & Inclusion, Featured, Research