Diversity in Clinical Research

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.

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