Q&A: NIH pilot to address clinical research disparities in underserved communities

Key takeaways:

• The pilot program aims to improve access to clinical research for the benefit of historically underserved communities.
• Research topics could include obesity, substance use disorders and maternal care.

The NIH announced that it has invested $30 million over 2024 and 2025 to pilot a national primary care research network that will integrate clinical research into community-based primary care.

The new initiative, dubbed Communities Advancing Research Equity (CARE) for Health, aims “to improve access to clinical research to help inform medical care, especially for individuals and communities that are historically underrepresented in clinical research or underserved in health care,” according to an NIH press release.

The agency added that certain primary care clinical sites will choose NIH-funded research studies based on health issues affecting and prioritized by their communities.

Additionally, initial awards will fund organizations that serve rural communities and are expected to be made this fall.

Disparities in clinical research has been a significant issue in the last decade. For example, a 2022 Health Affairs study on FDA approvals between 2014 and 2021 showed that less than 20% of drugs had data on treatment benefits or side effects reported for Black patients.

In the pilot, patients — which include older adults, diverse populations and those who live in rural areas or have lower socioeconomic status or education levels — “will be able to contribute their data to research in order to generate results that are clinically meaningful to them,” NIH said.

Speaking to Healio, Monica M. Bertagnolli, MD, FACS, FASCO, director of the NIH, discussed the need for this initiative, what clinical research areas will be of focus and more.

Healio: Why was CARE for Health needed?

Bertagnolli: We’re taking a very serious look at the overall health of people in the country and occurrences that are a real crisis. [For example], the fact that opioid use disorders or substance use disorders continue to rise in certain populations. Suicides. The obesity epidemic. Maternal health. Some of these are new and some are increasing, but a lot are chronic.

The same communities that have a lot of health disparities are also the ones that are predominantly affected by many of the diseases of despair. In those communities, we’re also making less progress than we are in ones that have better access. Those same communities are much less able to participate in research.

That’s what led to the launch of CARE for Health. The strategy to approach these communities is to look at primary care, because those are the front lines of care. It’s those kinds of communities that we really want to be able to conduct our research and understand how we can overcome these serious problems.

Healio: Are there any areas of clinical research or studies that are especially important for this program?

Bertagnolli: Many of these communities are not involved in research yet. NIH has been working for many years through initiatives — such as the IDeA Clinical and Translational Research Network — in communities that have less access. [Nevertheless], many people in these communities aren’t having an easy time getting care. If you’re not getting care, it’s hard to do research.

Every community is different. [For example], a rural community in Montana is going to have very different needs for research than a rural community in Southern Kentucky or an urban community in Queens, New York. Yet each one of them are a concern to us because they’re communities of need.

The research studies [will include topics] like high BP, diabetes, a lot of prenatal and maternal care, pediatrics, substance abuse disorders, mental health conditions, obesity and cancer screening and prevention.

Our plan for these communities, [because] they’re all very different, is to help support them to do research and allow the community to select what kind of research studies are most meaningful to them. Clinicians can pick which ones they feel most comfortable doing.

Healio: What sites will be included in the pilot, and how will CARE for Health grow following its initially outlined plan?

Bertagnolli: CARE for Health was launched as a pilot, and it’s launched in some challenging locations that are spread across the country. The final sites haven’t been selected yet, but we’re hoping to see that soon. Then we’d love to see this truly expanded into every area that could benefit from having NIH research present.

The real vision is that we could have a learning health system here in the U.S., meaning anybody who wanted to could participate in research.

If you live in a big city or near a big academic center, you have a lot of opportunities to participate in research. Those centers contribute a lot to learning. But that means we’re still missing out on so many people and so much of our country that’s critical to be able to deliver better health.

Healio: Is there anything else clinicians should take away from this initiative?

Bertagnolli: In the early days of getting ready to launch CARE for Health, we’ve been inspired by the great reception we’re getting in the communities — from clinicians and other health care providers. I’m so touched by how people have been waiting for this.

The most important thing is that they want us to listen to them, which is incredibly exciting. The research that is the most rewarding is research where the people we are serving are partners, and we’re able to listen to them and give them what they really want.

References:

• Green A, et al. Health Aff. 2022;doi:10.1377/hlthaff.2021.01432.
• NIH launches $30 million pilot to test feasibility of a national primary care research network. Available at: https://www.nih.gov/news-events/news-releases/nih-launches-30-million-pilot-test-feasibility-national-primary-care-research-network. Published June 6, 2024. Accessed July 22, 2024.