In this second of two parts on the developing participant diversity movement, sponsor, CRO and site representatives discuss the impact of the FDA’s recent draft guidance and the efforts they already are making to increase inclusivity in their trials.

The FDA’s April guidance on trial diversity planning may only be in the draft stage, but large pharma sponsors already are moving ahead with initiatives they expect to fit the agency’s bill when the guidance is final.

But while prominent sponsors, such as Sanofi, and CROs, such as PPD, have been quick off the mark, smaller organizations may move at a slower pace until it’s clear just how much weight the agency will give the guidance.

Despite the guidance’s draft status, it’s been enough to get prominent sponsors thinking about how they will approach the diversity plans the agency says it intends to heavily evaluate, Chris Komelasky, CEO and cofounder of integrated research organization SiteBridge Research, tells CenterWatch Weekly.

“Some of our pharma partners are talking specifically about the diversity plans now,” Komelasky said, “but it’s top 20 pharma and ones that have been leading the charge in the space over the past few years.”

“They had already started to define these goals and approaches internally,” Komelasky said. “I think the smaller pharma and biotech companies will lag a little and see how much focus the FDA actually puts on these at the start.”

Sponsors without diversity plans are actively seeking development support, says Lori Abrams, WCG’s executive director of patient advocacy and diversity. And PPD, the clinical research arm of Thermo Fisher Scientific, confirms that it also is collaborating with sponsors that are more advanced in their diversity planning and supporting those that are not as far along.

The FDA guidance should strongly resonate with sponsors given its directness, according to PPD.

“This guidance is the clearest and most specific signal” that the agency expects sponsors to discuss trial diversity plans early in the development process rather than waiting for requests for information postapproval, Rose Blackburne, vice president, global head, general medicine/women’s health at PPD Clinical Research, told CenterWatch Weekly. “It’s a tool that clearly lays out the approach sponsors should take in developing plans for their programs.”

Delivering tangible, formal diversity plans is an idea that appears to be clicking with sponsors, which for years have been required by the FDA to establish the same kind of plans to ensure their trials cover pediatric populations whenever possible, Komelasky noted.

And he predicts a shift in FDA and other regulatory agency definitions of a high-quality trial to include how well-defined and executed sponsors’ diversity plans are.

One example of an already-established diversity plan that fits the FDA’s model comes from pharma giant Sanofi. The sponsor’s diversity plan covers the five elements recommended in the draft guidance: an overview of the disease or condition; enrollment targets for racial and ethnic minority participants; scope of the drug development program; measures to enroll diverse populations; and justification of deferral to postapproval trials if diversity targets aren’t reached.

Sanofi begins by assessing the feasibility of its diversity strategies very early in trial planning. It connects with sites, patient advisors and patient groups to identify challenges for diverse communities and factors that may unintentionally restrict eligibility in a trial, said Naikia Atkinson, Sanofi’s director of U.S. clinical trials diversity and inclusion.

“Planning starts at the indication level, which is before we have a specific clinical trial design, to ensure our teams understand social determinants of health and other factors that impact clinical trial participation,” Atkinson said. Sanofi incorporates these factors into the trial design to ensure they are as inclusive as possible from the start.

The drugmaker then reconfirms its plans during feasibility and site selection visits, openly discussing its expectations for enrollment with investigators and research coordinators. In addition, the company has developed accountability, governance and performance measurement tools for measuring the diversity of its trials and identifying areas for improvement.

The company is on the lookout for new community-based sites it can bring into clinical research with the goal of improving access to trials for underrepresented populations, Atkinson explained. In addition, it’s working on tools and training material for sites to help them better grasp diversity enrollment targets, improve their engagement with diverse groups and help them better connect with their surrounding communities.

Allison Kemner, vice president of clinical sciences and operations for nascent cancer therapy developer Tyra Bioscience, said the company views diversity as a priority as it begins to grow, working with stakeholders locally and regionally to identify and address specific gaps and areas in need of support.

Efforts to improve inclusivity and diversity in trials shouldn’t be the sole responsibility of sponsors, Kemner emphasized. It’s an undertaking that the whole healthcare ecosystem needs to embrace.

She also cautioned sites and sponsors to look beyond race and ethnicity and noted that the FDA draft guidance covers other typically underrepresented groups, including patients with HIV or brain metastases, patients in rural communities, indigenous groups, LGBTQ+ and others.

“There does seem to be a rallying cry and momentum to focus on race and ethnicity to start,” added Komelasky. “This is a great place to do it because the disparity has been so visible there, but collectively we need to make sure the other dimensions of diversity don’t get lost in the shuffle,” he said, pointing to age, gender identity, socioeconomic status, rural vs. urban mix, other social determinants of health and the intersection of all these important demographics.

And PPD recommends sponsors and sites also examine disease demographics, socioeconomic burden and barriers to care to build optimal diversity strategies.