While anecdotal evidence and data from the U.S. Food and Drug Administration (FDA) suggest progress has been incremental at best, former clinical research associate (CRA) Sharon Duffy remains “optimistic” that raising awareness of the nagging lack of diversity in clinical trial patient populations is going to ultimately prevail, and make trials more representative of the people the drugs and devices are intended to help.
“The data suggest there’s not been as much progress as we’d like,” Duffy says, noting a small uptick in representation among non-whites in some clinical trials according to some data sources. “We need the patient populations to match the target for the drug,” she adds. Today, Duffy is associate director of clinical monitoring at Rho, and one of her big goals is to promote diversity in clinical trials.
Recent FDA statistics paint a somewhat discouraging picture, however, showing whites accounted for 72% of the patients who participated in trials in 2019, with blacks or African Americans and Asians at 9%, and Hispanics at 18%. In 2019, FDA’s Center for Drug Evaluation and Research approved 48 novel drugs, either as New Molecular Entities under New Drug Applications or as new therapeutic biologics under Biologics License Applications. Overall, 46,391 patients participated in these trials.
At Rho, Duffy and team are working to raise awareness of diversity-related challenges to studies with new and prospective CRAs by encouraging them to talk more openly with potential patients, doctors, and other trial personnel about the imbalance. “It’s important to acknowledge it can be a difficult conversation,” Duffy says.
For example, many in minority communities are wary of clinical trials because of past unethical practices such as the Tuskegee syphilis experiment, in which a group of African American men were told only they were receiving free medical care and not that their syphilis would go largely untreated during the trial. Another infamous case is that of Henrietta Lacks, a black woman whose cancer cells were cultured without her consent and used for decades for medical studies.
“In other cases, minority populations are not offered the same opportunities as white patients” because they are not approached as often about clinical trials addressing their disease or condition, Duffy says.
Author: Michael Causey
