The word “diversity” has become a political hot potato in the U.S. as the Trump administration ramps up its assault on DEI-related policies. For pharma, the stark regulatory shift has collided with major business initiatives already set in motion.
While many of the anti-DEI directives from the White House are aimed at hiring practices, the stakes go deeper for pharma, especially in the realm of clinical trials.
In recent years, the industry has been loud and proud about its quest to bring more diverse patient populations into R&D — a goal tied to the longer-term aim of improving health outcomes. Now, regulatory uncertainty has chilled the conversation, with companies stripping the word “diversity” from annual reports or opting for terms like “representation” instead.
The removal of the FDA’s draft guidance on clinical trial diversity from the agency’s website, followed by its reappearance — with a note that the agency and administration “reject” it because it’s “disconnected from the immutable biological reality that there are two sexes” — has injected even more uncertainty into the situation.
“[Diversity is in] a moving state in the U.S. … and there are many mixed signals,” said Aman Khera, president of TOPRA, an organization for professionals in regulatory affairs.
“Companies are not simply facing general uncertainty but are challenged by very specific gaps and inconsistencies in policy and regulatory frameworks."
Aman Khera
President, TOPRA
Still, individual pharma companies haven’t publicly wavered from clinical trial diversity aims just yet.
“The regulated industry including sponsors and research organizations remain committed to diversity and inclusion because there is strong evidence that having a more representative population in trials is good science, it’s good ethics and it’s good business,” Doug Peddicord, executive director of the Association of Clinical Research Organizations, a trade group that represents clinical research and technology organizations, told PharmaVoice in February.
Now, the challenge is figuring out how to navigate these uncertainties while still moving forward on past promises.
Regulatory pain points
At the Summit for Clinical Ops Executives last month, one question kept popping up from pharma companies designing upcoming trials, said Kim Ribeiro, chief client officer at Inside Edge Consulting.
“Up until this point … you could only be in two camps. You proactively submit a diversity plan or wait and see,” she said. “So the question has been: Do we keep proactively submitting it for feedback now that we’re not sure what’s going to happen? Or do we just write it, hold it and wait to see if the FDA is going to ask for it?”
For now, Ribeiro said the common advice for companies has been to “stay the course” with what they were already doing as the agency’s new leadership settles in.
Even if companies eventually aren’t required to submit diversity plans, they can still maintain those strategies to “ensure the science does not stop,” Khera said.
But this particular pain point adds to the existing complexity around implementing diversity plans.
“Companies are not simply facing general uncertainty but are challenged by very specific gaps and inconsistencies in policy and regulatory frameworks,” Khera said.
In particular, Khera pointed to the absence of clear benchmarks for diversity targets.
“Regulatory guidelines from the FDA often lack specific numeric targets. This leaves sponsors to interpret what constitutes adequate diversity based on the context of their indication, geography and trial phase,” she explained. “Adding to the complexity is the variation in how race, ethnicity and other demographic variables are defined across jurisdictions.”
When companies move ahead with diversity plans, issues can crop up quickly in the patient enrollment process.
“Regulators are placing growing pressure on sponsors to modify recruitment strategies in real time if diversity targets are not being met. However, the lack of clear regulatory guidelines for adaptive enrollment creates a challenging situation,” Khera said. “Companies must balance the need for flexibility with the risk that mid-trial amendments could prompt additional review or delay submissions.”
The FDA’s guidance has also failed to keep pace with the industry’s technology innovations, leaving questions around how companies can blend inclusivity goals with data collection capabilities and decentralized clinical trials. For example, while DCTs are promoted as a fix for recruitment, how the FDA will gauge the quality of data from trials conducted remotely is still unclear.
“This creates conflicting pressures for sponsors who must adopt these models to enhance diversity while navigating unclear regulatory expectations around data integrity, patient monitoring and privacy,” Khera said.
Where does pharma go from here?
Although the FDA’s clinical trial diversity guidance doesn’t close many of these regulatory gaps, it does provide a roadmap for crafting inclusion plans.
The guidance was expected to be finalized by the second half of the year, but the agency’s stance has left its fate up in the air. On rare occasions, the FDA has scrapped proposed guidance altogether, and if that happens in this case, companies would be left “without clear instructions on how to meet requirements” mandated by the DEPICT Act passed in 2022 to promote clinical trial diversity.
“The DEPICT Act … represents a step toward stronger enforcement,” Khera said. “Still, the effectiveness of this mandate will depend on how rigorously the FDA monitors compliance and addresses non-adherence.”
In the absence of clarity from the FDA, it’s up to the industry to keep inclusivity at the forefront.
As companies work to ensure clinical trial diversity, Khera recommends they solidify recruitment strategies by forging “stronger ties with community organizations” that boost trust and access, and leverage digital tools and tailored outreach plans to reach different patient populations.
Companies can also create their own monitoring and reporting metrics to measure recruitment success. And publishing that data will “drive accountability and continuous improvement,” Khera advised.
In addition, pharmas should continue to invest in training for cultural competencies, design patient-centric trials and keep diversity as a “core value” in the company’s ethos. And when going global with their trials, sponsors can take cues from other regulators, such as the U.K.’s Health Research Authority, as well as its Medicines and Healthcare Products Regulatory Agency, which published draft guidance last year and are piloting a program for submitting inclusion plans.
Engaging with the FDA could also help the agency shape future diversity rules.
At the recent SCOPE conference, Ribeiro said company leaders expressed their intent to keep up the work, even if they don’t know what diversity regulations will look like. She predicted it will be months before the dust settles from changes at the FDA, allowing companies to “see the trends” in the agency’s thinking.
Even without FDA guidance, Khera said diversity goals aren’t likely to disappear.
“The work does not stop here. There is much to do,” she argued. “Albeit a little quieter, I see a commitment in the industry that’s there and is not going away.”
