The National Institutes of Health (NIH) to planning 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 (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 healthcare.
NIH is investing approximately $30 million in total over fiscal years 2024 and 2025 in the project. CARE for Health will seek 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.
“Despite tremendous scientific progress, the health of important segments of the U.S. population is getting worse, not better,” said NIH Director Monica M. Bertagnolli, M.D., in a statement. “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 NIH-funded 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.
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-funded 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.
As part of the infrastructure, a Clinical Science Center will provide oversight of the studies/protocols and site and study selection as well as provide statistical and data management support. It will also develop innovative clinical study designs and implementation strategies to minimize burden on participants and providers in primary care settings.
An Operations Center will conduct site feasibility assessments, site agreements/contracting, and coordination of study operations (protocol development; compliance with Food and Drug Administration (FDA) and Office of Human Research Protections (OHRP) regulatory and participant protection requirements; communications; training; auditing; quality assurance; and data monitoring).
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, in a statement. “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.”
