As the Food and Drug Administration issues a new guidance for clinical trial diversity, a group of medical technology executives is working with the agency to improve diversity in medical device development.
Called MedTech Color, the nonprofit was formed by a group of Black medical device executives in 2017. They recently launched a collaborative community — a public-private partnership between the FDA and an outside organization to achieve a common goal.
Their objective is to not only increase participation in clinical trials to better represent the patients population, but to also to recruit diverse physicians and researchers, which can also be a significant factor in trial access.
For example, these leaders can not only shape how devices are developed, but might point out potential aspects of clinical trial design that could inhibit underrepresented communities from participating.
“A lot of the decisions about what companies might prioritize or how clinical development occurs happen as part of the natural life cycle of developing products. When you have diverse people in the room when those decisions are being made, you get diverse ideas,” said Vernessa Pollard, a partner with McDermott Will & Emery and one of the leaders of the initiative. “It’s not only that you need to have people who represent those groups leading the charge or having the conversation, but often people representing those groups are not in the room. We want to change that.”
The collaborative community also plans to create more awareness of different disease states, symptoms and prevalence rates among minorities, and identify unmet health needs.
This is important because there are unique considerations with different patient groups that aren’t always taken into account. For example, heart disease is the leading cause of death for women in the U.S., but most cardiovascular devices aren’t necessarily developed for women. Similarly, Black men get prostate cancer at a higher rate than white men, but are disproportionately underrepresented in clinical trials.
“I think what we’re driven by is this mutual desire for better health outcomes for all,” said Nada Hanafi, chief strategy officer for Experien Group and one of the leaders of the initiative. “We’ve seen poor outcomes where products have been used or misused in patient populations where they weren’t previously studied.”
Although laws have been in place since 2012 that require the FDA to take a closer look at clinical trial participation for different patient demographics, progress has been slow. One analysis published in the Milbank Quarterly found that of 22 devices deemed “highest risk” or novel, only half of them conducted any subgroup analysis and only one in three analyzed the device’s safety and effectiveness for gender, race and age. In most cases, there weren’t enough patients in each subgroup to draw meaningful conclusions.
Because of this, the agency has been emphasizing more flexibility in trial sites and broadened eligibility, as well as work with patient advocacy groups and communities in clinical trial design. Collaborative communities, like the one created by MedTech Color, are also part of the solution.
The executive planning committee for the collaborative community includes Hanafi, Pollard, Jamie Wheeler, vice president of global clinical affairs for Edwards, and Kenita Barrow, deputy general counsel for Otsuka America Pharmaceutical. FDA representatives are also engaged in the initiative.
“This is a real critical and important space regarding diversity and inclusion for the agency,” Hanafi said. “We’re excited to have (the FDA’s) know-how and participation and support of this.”