Life science consulting firm Trinity Life Sciences is calling on the FDA to implement minimum representation requirements for clinical trials to help boost diversity in studies.
While some companies have launched initiatives to address the issue, available data still clearly points to disparities in recruitment and enrollment, the company says in a new report (PDF). Notably, Black Americans make up 13% of the population but 5% of clinical trials. The gap is even worse for Hispanic or Latino Americans who make up 19% of the U.S. population but roughly 1% of clinical trial participants.
Now it’s time for the FDA to step in, according to the report, which assessed the state of play for improving clinical trial diversity. The authors urged the agency to come up with trial enrolment requirements that take racial demographics of specific diseases under consideration when working on a related clinical trial. The authors note that the agency “has not instituted any minimum requirements around representation.”
In November 2020, the agency released final guidelines for the industry to improve trial diversity, although the recommendations lacked concrete accountability measures. In one section, the agency recommended that “sponsors include a plan for inclusion of clinically relevant populations no later than the end of the phase 2 meeting.” But the agency pointed to 2016 guidelines on collecting race and ethnicity data that focused primarily on data collection techniques, rather than expanding diverse participation.
Run-around guidelines such as these encompass the larger problem: knowing potential solutions to a lack of trial diversity without any mandate to implement them. In its report, Trinity acknowledges that such requirements could slow down recruitment, which they counter by suggesting they be paired with additional measures that could be implemented relatively quickly.
Some of those measures have been spurred by the pandemic, including a shift to decentralized clinical trials and reducing non-clinical intervention appointments. But the report says other, more systemic barriers could be addressed including language barriers, assuaging fears regarding health insurance status and not recruiting based on minimum disease duration.
For example, Black women have been found to have longer delays in breast cancer diagnosis than White women, highlighting at least one disease where using duration as a means for inclusion criteria could ultimately hinder equity and representation.
Another short-term solution proposed by Trinity is reevaluating clinical trial sites so that they don’t become cemented in predominantly White communities. The study recommended that sites be set up in clinics that have yet to participate in a clinical trial but are “well-equipped to do so.” Some pharmas have committed to such work, including Bristol Myers Squibb, which in 2020 announced it would be putting 25% of clinical trial sites in “highly diverse communities”.
Ultimately, the report concludes that efforts to diversify clinical trials can not only bolster trust but also improve study reliability. But to have an impact, organizations will need to commit to a combination of reforms.
“While high-profile investments designed to understand and improve clinical trial diversity are important to addressing the gap, a multi-pronged approach with a combination of targeted, local, and individually prescribed support will be necessary,” the authors wrote.