NASEM Calls for Action by FDA, NIH to Improve Trial Diversity
In a congressionally mandated report on diversity in clinical trials, the National Academies of Sciences, Engineering and Medicine (NASEM) recommends the FDA require drug sponsors to file an in-depth recruitment strategy, either before or with their investigational new drug (IND) or investigational device exemption (IDE) applications, that details how they intend to make their trial population reflective of the disease or condition’s demographics.
While the agency recently issued guidance on this very idea, it recommends rather than requires a diversity plan (CenterWatch Weekly, April 18). And the pharma industry has said that while it is in favor of the overall movement to improve diversity, it doesn’t support extra sponsor requirements (CenterWatch Weekly, March 21).
NASEM’s study and subsequent report found that while the diversity effort as a whole has made progress, particularly on bringing more White women into trials, work urgently remains to be done for other groups, particularly racial and ethnic populations but also older adults, pregnant and lactating women and LGBTQIA+ groups.
The report also advises Congress to require an FDA task force to develop incentives for new drug and device trials that are adequately representative. These could range from tax incentives, fast-track criteria and exemption from some FDA drug application fees to longer market exclusivity for sponsors who meet predefined representation targets. Additionally, Congress could arm the agency with the power to refuse applications that don’t represent their target populations, the report suggested.
NASEM also calls for a multidepartment task force under HHS charged with producing yearly reports on the state of clinical trial enrollment in the U.S., including the number of patients recruited into trials by phase and condition, age, gender, race, ethnicity and trial location. The task force should also develop guidance on equitable compensation to participants/caregivers and a definition of “representativeness” for trial protocols and product development plans, NASEM suggested.
The report also suggests NIH begin formally considering participant representativeness as part of their grant proposal review criteria.
Access the full report here: https://bit.ly/3wGBnxC.