The outcomes of clinical trials are often affected by the diversity of the patient population studied. Things like race and gender can make a real difference in the way drugs work– and yet women, minorities and older adults continue to be underrepresented in pivotal trials for new medications . Two recent studies demonstrate that fact over the last several decades. And although the proportion of these populations enrolled in clinical trials has increased, it is still well out of step with the number of patients affected by the diseases in question. Sr. Editor Gretchen Cuda Kroen spoke with Dr. Erin Michos, co-author on those studies about the origins of the disparity, and what what we can do about it.
Khan MS, Shahid I, Siddiqi TJ, et al. Ten-Year Trends in Enrollment of Women and Minorities in Pivotal Trials Supporting Recent US Food and Drug Administration Approval of Novel Cardiometabolic Drugs. J Am Heart Assoc. 2020;9(11):e015594. doi:10.1161/JAHA.119.015594
Khan SU, Khan MZ, Raghu Subramanian C, et al. Participation of Women and Older Participants in Randomized Clinical Trials of Lipid-Lowering Therapies: A Systematic Review. JAMA Netw Open. 2020;3(5):e205202. Published 2020 May 1. doi:10.1001/jamanetworkopen.2020.5202