Tarver says clinical trial diversity action plans are a marketing opportunity

TORONTO – Medical product sponsors should consider clinical trial diversity plans as not only a regulatory requirement but also a marketing opportunity because they will give companies data that is more representative of their patients, according to Michelle Tarver, who was recently named director of the US Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH).

“What we've said is that it is still draft, it is not required, but once it is finalized within 180 days of that, it will become required,” said Tarver. “So, we're encouraging people to take the opportunity to test it out. Come talk to us.”

Tarver made these remarks during a panel at the 2024 Medtech Conference on 16 October, where she discussed FDA’s work to promote health equity and its congressionally mandated requirement to ask sponsors to improve clinical trial diversity. In particular, she discussed the agency’s draft guidance on clinical trial diversity action plans and encouraged sponsors not to wait for the guidance to be finalized. (RELATED: Diversity action plans: Stakeholders seek clarity on demographic data, enrollment, and global trials, Regulatory Focus 3 October, 2024)

She said that FDA has already seen sponsors submit clinical trial diversity action plans across the agency and encouraged others to do the same.

“I think people have a lot of concerns around it, but I do think it's an opportunity that we can leverage and not look at it as something that's a requirement because there are marketing opportunities that are opened by including more people that look like the US population in your trials,” said Tarver.

"If you are developing a product and you've enrolled people from [different demographics], you expand the opportunity to sell products to those same populations and it also may give you insights into how you may want to look at your commercialization strategy too,” she added. “Thinking about it early, intentionally enrolling people pays dividends downstream."

While FDA is reviewing stakeholder comments before finalizing the guidance, she talked about the key elements of the clinical trial diversity action plan guidance, which point to the need to be proactive when designing clinical trials.

“Think about how are you going to identify the appropriate population by considering which populations bear the greatest burden of disease that you intend your device to work for,” said Tarver. “How are you going to identify those populations and enroll them in your trial and then how are you going to ensure you're collecting the data that you need to make an informed decision.”

“There is no statement in the diversity plan guidance that says anything about powered analysis, so I want to make sure that people are very clear it is just saying be intentional, be proactive, be forward-leaning and plan to include, don't just scramble at the back end to try to include,” she added.

Tarver said CDRH is also looking at updating its guidances on collection reporting of age, race, ethnicity, and sex in clinical trials as a result of its work on the clinical trial diversity action plan guidance. In particular, she said the agency is looking at its race and ethnicity guidance due to data collection changes that the Office of Management and Budget (OMB) has implemented.

In addition to the guidance, Tarver also touched on FDA’s August health equity discussion paper that delves into how sponsors should think about their clinical trial enrollment plans, the population they need to study, and factors such as the physiological and anatomical characteristics that may be important to consider when designing a medical product. (RELATED: Risk and data availability key to regulating health equity in device development, Regulatory Focus 15 October 2024)

Tarver said that health equity is important to her personally because when delivering her daughter, the pulse oximeter used to monitor her oxygen levels failed to work effectively. As a result, she suffered respiratory depression, and she had to be admitted into the intensive care unit. Despite her socioeconomic status, education, and connections, she highlighted that the medical system almost failed her.

"Thankfully, I had a good outcome, but not everybody does,” said Tarver. “That's why it's important to the agency."

“It's important to the agency because a lot of people just like me across this country and across the globe also want the benefits of medical products that work for them,” she added. “Our initiative is making sure no person is left behind in healthcare, that everybody has an opportunity to realize the maximum benefits for the devices that are intended to be used by them.”

In the pulse oximeter example, Tarver said there are many people in the US and around the world with brown skin tones on whom the device isn’t as effective, and it’s important to ask whether products will work on the full range of patients they are intended for.

“There's a lot of different populations across the globe that have browner skin and so making sure that you take a look at the spectrum of pigment may be the important question, not are you African American or not,” she added. “I think the other important thing that we have in that discussion paper is also considering the technology, how does the technology work, are there certain principles that could be impacted by other features.”

Tarver says clinical trial diversity action plans are a marketing opportunity

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