July 15, 2024, 12:23 PM EDT
By Kelly Bilodeau (Originally published July 8th on PharmaVoice)
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The FDA has taken another tangible step toward boosting diversity in clinical trials. The agency recently released a long-awaited draft guidance revealing more details about how sponsors can create Diversity Action Plans to enroll trial participants who more fully represent the people using products once they hit the market.
The guidance, which applies to some phase 3 trials, replaces an earlier, less detailed guidance document issued in April 2022.
“Congress sought to fix the underrepresentation of minority patient populations in clinical research by requiring companies to submit their plans for enrolling trial participants that truly represent the patient populations for the products tested in the trial, otherwise known as diversity action plans,” said Rohit Nambisan, CEO and cofounder of Lokavant, a clinical trial intelligence platform. “The recent FDA’s draft guidance is the first step in carrying out the new law.”
Testing drugs in a diverse population helps ensure they work safely in a variety of patients. Older adults, for example, may take longer to metabolize certain medications, increasing the risk of toxic reactions at standard dosages. Of course, genetics can also play a role.
The FDA’s Diversity Action Plans call on sponsors to identify the ideal patient mix for a trial and outline a detailed recruitment plan.
The new guidance also spells out which trials need diversity plans, the nuts and bolts of plan formatting, timing and submission, and the waiver process.
“The guidance also urges sponsors and investigators to consider the many dimensions of clinical trial diversity, even those that extend beyond age, ethnicity, sex and race to enroll populations that represent the patients who will be treated if the product is approved,” according to a press release from the FDA.
“Now that we have a draft guidance outlining the requirements for diversity action plans, we will see more organizations developing smarter plans,” Julie Ozier Senior vice president, IRB review, Advarra.
Challenges ahead
While pharma has generally been supportive of diversity initiatives, getting new faces into clinical research is not always easy and many trials are falling woefully short of diversity goals.
Determining the right combination of participants may be challenging for some trials designs but straightforward for others, including common conditions where patient demographics are well understood, according to Dr. Pamela Tenaerts, chief science officer at Medable, a decentralized clinical trials software company.
A recent Office of Inspector General report found that many NIH-funded trials weren’t attracting enough people from underrepresented groups.
However, this new guidance may create another hurdle for sponsors to clear.
“While the FDA’s requirement of diversity plans baked into protocol designs shall eventually yield many important benefits to clinical sciences, and humankind … [and] clinical trial sponsors are now saddled with even more complexity to manage, more data to absorb, and more risk,” Nambisan said.
Although the guidance isn’t final, organizations should prepare and note similar state laws cropping up across the country, said Julie Ozier, senior vice president of IRB review at Advarra.
“For example, Washington State passed a Diversity in Clinical Trials Bill requiring investigators to collaborate with community-based organizations and use methods recognized by FDA to identify and recruit underrepresented populations,” she said.
The FDA’s 2022 draft guidance called on organizations to create Diversity Action Plans, and after later analyzing 91 oncology submissions, the agency found that 13% omitted required elements. Tenaerts recommends that drugmakers review these findings to help avoid common missteps.
While many companies already have their own diversity plans in place, changes to real-world outcomes will likely be incremental.