The primary purpose of clinical trials is to determine the safety and efficacy of medical treatments in the human body. The manifestation of disease, its progression, and the character of treatment may all present uniquely in subsets of the population, including those based on age, gender, racial and ethnic groups, lifestyle, and environment. Group underrepresentation in clinical trials can therefore result in the development of treatments that influence health disparities and inequalities across the United States.
In November 2020, the United States Food and Drug Administration (FDA) published a course of action outlining the various methods of enhancing diversity in clinical trial populations, by means of altering eligibility criteria, enrollment practices, and trial designs. The FDA recommends establishing eligibility criteria that encompass the population(s) for which the drug is designed, resulting in a representative sample. To broaden enrollment practices, the FDA suggests enrollment of participants who reflect clinically relevant populations, including but not limited to women, children and adolescents, older adult populations, and racial and ethnic minorities. Additionally, the FDA endorses the adaptation of practices to augment inclusiveness—such as working directly with communities to address their needs, implementing electronic communication, using mobile medical professionals, and promoting representation across all subgroups.1
With the application of the FDA guidelines, stronger efforts can be made to combat not only the matter in question, but the larger predicament at hand—health disparities. Recognizing the inequality deeply rooted in this underrepresentation is important for the progression and potency of clinical trials for all people. Overcoming this impediment is a step toward health equity, essential to the advancement of medicine.
- Clark LT, Watkins L, Piña IL, Elmer M, Akinboboye O, Gorham M, Jamerson B, McCullough C, Pierre C, Polis AB, Puckrein G, Regnante JM. (2019). “Increasing diversity in clinical trials: overcoming critical barriers.” Current Problems in Cardiology, 44(5):148-172.