Explain Need for Trial Diversity: Caplan
New York University bioethics professor Arthur Caplan says that among all the efforts to increase clinical trial diversity, what’s missing is a clear explanation of why it is so important. In a Stat First Opinion post, Caplan reviews some recent announcements from FDA and other stakeholders calling for greater diversity among clinical trial participants.
“To be sure,” he writes, “therapies may differ in their safety and effectiveness for different patients. That is obviously an important concern. But what does it mean for expanding participation in clinical trials?”
He questions whether the incidence of disease among groups should guide where expansion efforts focus. And he challenges the rationale that all Americans ought to have access to the benefits of clinical trials since, he says, being in an experiment is not usually considered a benefit.
Caplan says an unexplored challenge amid the calls for diversity is the continued use of “outdated racial categories to measure inclusivity.” He points out that in a time of precision medicine and exploding knowledge of genetics, it hardly makes sense to refer to broad racial and ethnic groups as monolithic biological classes. “The notion that categories based on grim histories of racism and prejudice ought to guide subject recruitment in an era of multiracial identity, known genetic variability within groups, and wide genetic variation in the social categories being invoked is outdated and inaccurate,” Caplan writes.
The post suggests that since clinical trials in the U.S. have long skewed toward recruiting mostly white people, that is a justification for rethinking what is meant by diversity.
“In an era of sophisticated genetics defining ideas about race and ethnicity, using unscientific categories unique to America makes little sense,” Caplan concludes. “And pointing toward access to trials as a benefit to justify efforts at diversity when so many Americans are uninsured or saddled with crippling medical debt that mean they cannot access the breakthroughs of research makes even less sense.”