New initiative aims to integrate clinical research in everyday primary care settings

The National Institutes of Health (NIH) is investing approximately $30 million in total over fiscal years 2024 and 2025 to pilot a national primary care research network that integrates clinical research with community-based primary care. The new initiative called Communities Advancing Research Equity for Health—or CARE for Health—seeks to improve access to clinical research to inform medical care, particularly for those in communities historically underrepresented in clinical research or underserved in health care.

Informed by the health needs of these communities, CARE for Health will help to grow an evidence base that contributes to improved patient outcomes, provide communities access to the best available scientific research and expand opportunities to participate in clinical trials and studies. NIH Director Monica M. Bertagnolli, M.D., lays out her vision for CARE for Health in a Science editorial.

"Despite tremendous scientific progress, the health of important segments of the U.S. population is getting worse, not better," said Dr. Bertagnolli.

"Health is dependent upon many factors. We recognize that environmental and societal factors are very important, and that each community is unique. Because of this, we must adapt our research to be more inclusive and more responsive to the needs of communities currently underserved in health research. Our vision for CARE for Health is to help primary care providers and their patients contribute to knowledge generation, and to deliver evidence back to them to achieve better care."

Supported through the NIH Common Fund, CARE for Health will initially leverage existing clinical research networks and community partners to establish the infrastructure that will support research at select primary care sites. Initial awards will fund organizations that serve rural communities and are expected to be made in fall 2024.

"Health research should be accessible to all populations. Clinical trials should reflect the diversity of Americans—because we know that delivers the best results," said HHS Secretary Xavier Becerra. "We are taking a big step towards ensuring communities that are historically underrepresented in clinical research are fully included and have the same access to the best available results and analysis. There has never been more potential for progress than we have today."

Participating clinical sites will be able to choose research studies based on health issues affecting and prioritized by their communities. Patients will be able to contribute their data to research in order to generate results that are clinically meaningful to them. Final study findings and aggregate results will be shared with research participants.

CARE for Health will expand NIH research studies to increase engagement with people from communities historically underrepresented or underserved in health care and clinical research. This includes people from certain racial and ethnic groups, those who are older, those who live in rural areas and those who have low socioeconomic status or lower educational attainment. Studies will seek to address common health issues, as well as disease prevention.

"Community-oriented primary care not only provides essential health services, but it also engenders trust among those who lack confidence in recommended medical care or science," said Dr. Bertagnolli.

"In fact, greater availability of primary care services in communities is associated with fewer disparities in health outcomes and lower mortality. We earn people's trust when they get access to the care they need and when they can see direct benefits from their participation in research."

As CARE for Health expands, the program will launch new studies across the network and further establish study sites, training capabilities, data management and increased interoperability. By expanding collaborations to integrate research data into clinical practice and clinical data collection into research studies, the network will facilitate the use of innovative practices and trial designs to minimize burden of research on primary care providers and patients.

"The goal is to create a learning health system in which research informs clinical practice and clinical data informs research," said NIH Deputy Director for Program Coordination, Planning, and Strategic Initiatives Tara A. Schwetz, Ph.D.

"As the program grows, sites and their communities will help design new clinical studies reflecting their specific health needs, and results from those studies will inform the care they receive."