US FDA draft guidance tasks trial sponsors with creating diversity plan
The US FDA has asked drug development sponsors to detail efforts to ensure ethnic diversity in clinical trials.
The regulator made the suggestion in draft guidance last week, advising that trial sponsors should submit a “Race and Ethnicity Diversity Plan,” which sets out diverse participant enrollment and retention processes early in clinical development.
The aim is to make studies enroll participants from a broad range of ethnic populations according to the FDA, which cited African American, Hispanic/Latino, Indigenous and Native American, Asian and Native Hawaiian as examples of underrepresented groups.
“Individuals from these populations are frequently underrepresented in biomedical research despite having a disproportionate disease burden for certain diseases relative to their proportional representation in the general population.
Adequate representation will ensure trial data reflects the ethnic diversity of the population expected to use product and may help identify safety or efficacy outcomes that occur more frequently within these populations according to the agency.
Diversity drive
Efforts to make trials more diverse have been a major focus for the clinical research sector in recent years.
According to a 2020 study fewer than 10% of US patients participate in trials, and of those, only 5-15% are non-Caucasian – even though those ethnicities make up nearly 40% of the population.
And research published earlier this year by Trinity Life Sciences suggests COVID-19 has exacerbated the problem. According to the study 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.
The new draft guidance expands on ideas put forward by the agency at the end of 2020.
However, rather than concentrating on trial design, the new guidance is designed to prompt the sponsor to develop its own plan to increase diversity.
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