FDA addresses biopharma's diversity problem with new draft guidance
Back in 2020 — as drugmakers struggled to enroll diverse populations in Covid-19 trials — the FDA released new guidance urging pharma companies to devise a plan for making their studies more inclusive. In its latest draft guidance, the agency is filling in more of the details.
The FDA provided a draft framework on Wednesday for drugmakers and medical device manufacturers regarding plans to enroll more diverse trial participants. Part of that framework includes setting goals for enrollment and specifying retention strategies, such as providing language assistance and reducing the burdens of participation with tools like telehealth.
In its guidance two years ago, regulators suggested that drugmakers submit diversity plans no later than the end of Phase II meeting.
“Going forward, achieving greater diversity will be a key focus throughout the FDA to facilitate the development of better treatments and better ways to fight diseases that often disproportionately impact diverse communities,” FDA commissioner Robert Califf said in a statement.
The pharma industry has long suffered from a lack of diversity, and the problem has only been exacerbated by the pandemic. Of the 53 drugs approved in 2020, Black patients represented about 8% of participants in the clinical trials regulators based their decisions on. To put that in perspective, Black Americans represent about 13% of the US population. Hispanic patients represented just under 13% of trials, and Asian patients just over 6%.
But as the FDA pointed out in its draft guidance, it’s not about total population — it’s about the population of patients expected to use a medication.
Some minority groups are frequently underrepresented in research areas despite being disproportionately affected by a specific disease, the FDA acknowledged. Black Americans, for example, accounted for only 7% of participants in clinical trials that led to cancer drug approvals between 2014 and 2018, despite the fact that they die from most cancers at higher rates than any other racial group, according to the American Cancer Society.
Acknowledging that — and any potential differences in safety or efficacy outcomes across populations — is the first step, the FDA said.
“FDA is focusing this guidance on diversity plans to improve enrollment of participants from underrepresented racial and ethnic populations because the lack of representation of these populations in clinical research reflects, in part, a broader issue regarding differential access to health care,, including access to centers that conduct clinical research programs for new therapies and awareness of clinical trials conducted there,” the guidance states.
Companies should also focus on retaining participants, and the FDA provided examples of what that might look like: working with community health workers and patient advocacy groups, limiting the frequency of study-related procedures, or even offering financial reimbursement for expenses required to participate.
Last year, Parexel touched on some of those barriers in results from listening sessions with physicians, interviews with the public, patient advisory council meetings, and a global survey to gauge perspectives on clinical trial diversity.
“Clinical trials, especially those within minorities and in certain areas, need to be accessible for those with limitations, both physically and financially. Many forget that even in this day and age not everyone has access to the internet or public forms of transportation,” an unnamed respondent said.
Drugmakers should submit their plans to the relevant IND application “as soon as practicable,” the FDA recommended — though definitely before they seek feedback on pivotal trials.