Clinical trial diversity is garnering more attention from lawmakers as they seek to resolve a longstanding deficiency amid a larger national focus on health equity.
The House Energy and Commerce Committee’s health panel Wednesday will consider a bill (H.R. 7845) that would require researchers to submit “clear and measurable goals” in their grant applications to recruit and retain clinical trial participants who reflect the race, ethnicity, age, and sex of the patient or general US population. The bill would apply to clinical trials funded by the National Institutes of Health.
“This is what we’ve wanted with NIH funding for a really long time,” said Reshma Ramachandran, a Yale School of Medicine family physician and the FDA task force chair for Doctors for America.
“In the whole drug pricing debate, the thing that’s come up again and again is: how do we ensure a fair return on our public investment? And this is one step towards that to make sure that your taxpayer money is actually going to be used for things that will benefit taxpayers in general,” Ramachandran said.
The legislation aims to build upon laws going back to the 1990s to improve the inclusion of women and underrepresented populations in clinical trials.
“There’s a recognition that clinical trials are really important and getting them right makes a lot of sense,” said Heather H. Pierce, senior director for science policy and regulatory counsel at the Association of American Medical Colleges.
“The conversation has gotten beyond the, ‘Yes, it’s a good idea,’ and has moved into, ‘So how do we do it? How do we move forward?’” Pierce said.
NIH-funded research has contributed to more than 90% of new drugs approved by the Food and Drug Administration over a six-year period, according to a 2018 study in the Proceedings of the National Academy of Sciences.
The hearing will examine nearly a dozen health bills, about half of which pertain to the NIH. The House earlier this month advanced similar clinical trial diversity requirements for drug and device companies as part of its FDA user fee package (H.R. 7667).
The two bills are complementary efforts to fill in the gaps, since the NIH bill applies to all the clinical trials it funds, whereas the FDA bill applies to the larger studies used to make approval decisions, said Shahana Koslofsky of Rep. Robin Kelly (D-Ill.)'s office said.
Kelly is the main sponsor of the NIH bill and a cosponsor of the FDA bill. Koslofsky is part of the American Association for the Advancement of Science’s fellowship program, which places scientists and engineers within the federal government to learn about policymaking.
“We’re just trying to kind of create this comprehensive catch-all to ensure that we are really meeting the needs of of all individuals, irrespective of race, ethnicity, age and sex,” Koslofsky said, “and that we’re really doing our job to kind of close health equity gaps and ensure that everybody has equal access to the most up-to-date innovative treatment strategies.”
Equity in health care is a key piece of the Biden administration’s agenda. But recruitment for clinical trials remains low generally, and it’s even lower for underrepresented populations. A study published last year found many researchers still aren’t reporting their required demographic data, and Black, American Indian or Alaska Native, Hispanic, and older adults continue to be underrepresented.
Ramachandran said she wished both bills had stronger enforcement mechanisms. In the NIH bill, sponsors that don’t meet the required diversity goals would have to consult with the NIH as well as community-based organizations within 90 days to come up with a strategic plan to increase participation.
“But I do think this is at least a step forward in the right direction,” she said, “and also for hopefully motivating some of the best actors to push the field a little bit more so that other sponsors will follow suit, and engage in more meaningful clinical trial diversity outside of what industry has been proposing.”
The bill allows for waivers if the study doesn’t impact all populations proportionately. Information on the strategic plans would be posted on a publicly available website.
“We really see the diversity plan as a North Star. So NIH and the sponsors are on the same page about what the expectation is for the clinical trial and the type of diversity that is expected for that trial, Anita Burgos, Kelly’s senior health policy adviser, said.
“But it’s not like we’re going to take away your funding or anything like that if you don’t reach those goals,” she said, adding that Kelly’s office sees the bill as a step above existing NIH measures to ensure there are regular checkpoints to discuss clinical trial diversity goals.
NIH clinical trial spending has doubled in less than a decade to about $6.5 billion a year, but industry far outspends federal dollars. Drug companies spent at least $54.6 billion in 2020 , according to a membership survey from the Pharmaceutical Research and Manufacturers of America.
Federal regulators are increasingly factoring in the diversity of study populations when making decisions on whether to make treatments available, Michelle McMurry-Heath, president and CEO of the Biotechnology Innovation Organization, said recently during her trade group’s convention in San Diego.
“We are seeing a sea change in how people are considering data and and it would behoove each of us to get ahead of it instead of behind,” McMurry-Heath said.
The Medicare agency based much of its decision to restrict
Covid-19 vaccine makers also worked to ensure a diverse population, in part due to efforts from industry and community partners but also to meet the demand of regulators, which McMurry-Heath, a former associate director for science in the FDA’s device center, called “a very wise thing to demand.”
She recalled how she wanted to diversify trials when she led a clinical team at
“That’s a really tough sell,” she said. “So we have to make sure we’re bringing down the cost and time of diversifying trials, but we also have to figure out some combination of carrots and sticks” to level the playing field.
The FDA issued draft guidance in April on diversity study plans but it lacks the authority to require them, which is what H.R. 7667 would do. PhRMA has indicated it would oppose mandates, arguing that they won’t overcome known barriers to participation.
In addition to new grant application requirements, the NIH bill would apply anti-discrimination rules under the Affordable Care Act to clinical trials.
It would also require a review of a human subjects protection regulation known as the Common Rule (45 CFR 46) under a section of the bill about eliminating cost barriers. The Common Rule requires minimizing the possibility of coercion or undue influence. But it’s raised questions over whether ethics review boards place too much emphasis on undue influence, resulting in a ban on payments or underpayments to research participants in a way that could prevent participation.
Holly Fernandez Lynch, a bioethicist at the University of Pennsylvania who’s written extensively on payments to research participants, said she believes it has. She said “it’s about time” to implement changes.
A Health and Human Services advisory committee made these recommendations in 2019.
“But the guidance still sows seeds of doubt regarding compensation (payment for time and effort) and incentives (payment to encourage participation beyond reimbursement and compensation),” Fernandez Lynch wrote in an email. “That doubt is problematic and inhibits an important tool to both treat participants fairly and help important studies complete enrollment.”
Wednesday’s hearing will also include several bills aimed at curbing undue foreign influence in NIH studies, a bill aimed at spurring more pediatric research (H.R. 3773), and a bill to continue funding the IMPROVE study, which aims to reduce maternal mortality and morbidity (H.R. 7565).
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