Graphic of a diverse crowd gathered in the shape of a stethoscope.

6 ways to bolster FDA’s guidance for diversifying participation in clinical trials

By Nicholas Kenny, Keri McDonough and Stephen Keith, STAT

It has been nearly 25 years since the Food and Drug Administration first issued guidance related to racial, ethnic, age, and gender populations underrepresented in clinical trials (see “Timeline: Related prior FDA guidance”). Yet it and other agency guidance and clear documentation of unequal representation have yielded little progress in improving clinical trial diversity.

The FDA’s latest draft guidance on diversity among clinical trial participants, published in April 2022, along with other efforts by the agency and other governmental entities to improve representation in clinical trials, is a welcome step forward.

Increasing the racial and ethnic diversity of clinical trial participants is a scientific and ethical imperative emerging from differences in disease causality, presentation, and progression; in access to health care; and in drug safety and effectiveness across diverse populations.

Released in tandem with a rising, long overdue industry scientific and ethical imperative for more diverse trial participation, the proposed FDA plan has the potential to be a critical propellant for more inclusive research. Within this context of renewed focus on diversity, equity and inclusion, meaningful and sustainable change should not only be mandatory but achievable. And for the first time, this FDA guidance is prescriptive in clearly telling biotech and pharmaceutical companies to come with a plan to FDA meetings. Read more …