Clinical trials underserve the public health and, in some cases, limit the value of the data amassed from a pool of subjects, say a number of experts in the field and officials at the U.S. Food and Drug Administration (FDA). Too often “minorities are underserved and it may impede their health,” suggests Lea H. Becker, senior clinical research coordinator with the Department of Emergency Medicine at the University of Virginia Health System.
On the positive side, Becker is encouraged by a survey she recently conducted that looked at 500 consent conversations in an emergency room environment. It suggested that the recruitment gap has closed tight between minority and white patient populations. “I was really happy about it,” Becker says, “I believe it reflects a concerted effort” at her facility bolstered by outside community outreach. She does note that conditions in an emergency room are “very different” than in others settings. Regardless, she advocates the adoption of what she calls “thinking tools” to help other facilities close that recruitment gap.
“Be clear on who you are approaching, and how much they need to know about a study in advance,” advises Becker. Conversely, ask yourself why are not approaching a particular group. Do you believe, based on anecdotal evidence or your own perceptions, that some groups simply don’t follow up and are too much of a hassle to recruit? “That’s not fair,” Becker says.
By applying thinking tools, it is easier to draw disparate populations into a clinical trial, Becker adds. She allows that egregious lapses in clinical trial ethics that have been brought to light over the years have sometimes highlighted racism as an issue in research that might have made industry professionals overly cautious in their outreach to underrepresented groups. Sensitivities related to clinical trials remain an important factor in some minority populations.
Meanwhile, FDA is co-hosting a seminar in September on improving clinical research in the age of precision medicine.
Speakers include FDA Commissioner Dr. Robert Califf and FDA Assistant Commissioner for Minority Health Dr. Jonca Bull. “The symposium is a unique opportunity to engage with clinical researchers on the front lines in academia and industry to make the case the importance of diversity in clinical trials to advance medical product development that represents the many faces of our country,” says Bull. Look for a full interview with her in the October issue of Clinical Researcher.