by James Nataro, MD PhD MBA, Chair, Department of Pediatrics
In the October 7, 2021 edition of the New England Journal of Medicine the editors delivered a shot across the bow to the American community of clinical investigators. The editorial, entitled “Striving for Diversity in Research Studies” issued a call to increase representativeness of study populations in clinical trials. Specifically, the editors decried the status quo under which clinical studies over-represent white and privileged populations and under-represent certain minority groups. The problem is essentially one of external validity: if the authors report a significant effect for an intervention or exposure in a population that does not represent the population naturally exposed or afflicted, are the results of the study applicable to the real world?
In an effort to increase the validity of clinical trials, the editors will now require for every manuscript describing a clinical study the addition of a supplementary table on the representativeness of study participants. In such a table, the authors are expected to articulate the demography of the disease under study and describe how their subject population reflects that natural population. Unfortunately for investigators, having a truly representative subject population means that they must overcome language, cultural, and social economic barriers to the inclusion of a truly representative subject population.
But fortunately for UVA, the iTHRIV CTSA (Clinical and Translational Science Award from NIH) is here to help. Recognizing that enrolling a representative subject population adds to the value of clinical research reports, iTHRIV serves as a clearinghouse for resources to close the gaps between the real and the ideal clinical study. For example, iTHRIV has initiated a program whereby supplemental funding can be provided to investigators to help overcome obstacles to the recruitment of under-represented populations. iTHRIV also can connect investigators to community programs and liaisons and to other investigators who have ready access to these populations.
Of course this is just one of many ways that iTHRIV promotes sound and rigorous clinical research at its three institutions: UVA, Carilion/Virginia Tech, and INOVA health system. iTHRIV supports mentored research awards and pilot grants, provides foundational resources such as study design and analysis expertise, and strives to create an environment of excellence in clinical research. Before you initiate a clinical study, learn about iTHRIV resources on its portal at https://portal.ithriv.org.
Rigorous, externally valid clinical trials that truly represent populations are the cornerstone of health innovation. As never before, the Covid pandemic has shed light on our ability to deliver rapid, efficient, and reliable translation of science to the clinical arena. Our opportunity to advance the frontiers of health is one of many reasons we are proud to be in academic medicine. Simply stated: we make life better for people around the world.
Filed Under: Features