Program Snapshot

There is a critical need to extend research participation opportunities to broader communities. This is, in part, because people who are historically underrepresented in research are also often medically underserved and disproportionately impacted by disease and illness (e.g., certain racial and ethnic groups, gender minority groups, people who live in rural environments, older adults, persons experiencing challenging social determinants of health and related experiences). When research study demographics don’t match the demographics of the illness or condition being studied, generalizability of the evidence is compromised, further compounding these health disparities. While most have not talked with their doctor about participating in health research, Americans increasingly agree that opportunities for participation in clinical trials should be a part of regular healthcare. 

Therefore, NIH is proposing to establish a network to conduct research in primary care settings. This network will address barriers to access to clinical research participation by implementing a sustained infrastructure that integrates innovative research with routine clinical care in real world settings, with a focus on sustained engagement with communities that are traditionally underrepresented in clinical research. Improving access to clinical studies will facilitate and accelerate research advances for adoption and implementation into everyday clinical care, improving health outcomes and advancing health equity for all Americans. 

The four goals of this initiative are to: 

• Pilot and implement the infrastructure for a network on primary care-focused clinical research to serve all ICs, particularly those without their own large-scale networks.
• Establish a foundation for sustained engagement with communities underrepresented in clinical research (e.g., racial and ethnic minority groups, gender minority groups, people who live in rural environments, older adults, persons experiencing challenging social determinants of health and related experiences).
• Implement innovative study designs that address common health issues, including disease prevention.
• Engage with community and health care systems to integrate innovative science with routine clinical care and change clinical practice as a result of the research outcomes

The network will involve the following components: 

• Clinical Science Center
  • Providing oversight of the studies/protocols and site and study selection.
  • Providing statistical and data management support
  • Developing innovative clinical study designs and implementation strategies to minimize burden on participants and providers in primary care settings.
• Operations Center – Conducting 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)
• Independent Review and Monitoring Boards - Including Data and Safety Monitoring Board (DSMB), Observational Study Monitoring Board (OSMB), and the Central Institutional Review Board (IRB)
• Network Research Hubs – Leveraging existing research networks and partnerships with Clinical Sites to conduct clinical research in primary care settings.
• Community Engagement – Providing support, advice, and resources, in part through partnerships with existing entities, to facilitate sustained participant and community engagement, community-driven research, and integration of studies in primary and community care settings.
• Industry Partnerships – Engaging for-profit partners for collaborative knowledge sharing and potential participation in/use of the infrastructure.

Interested in receiving program updates? 
Sign up for the NIH Common Fund’s program on integrating clinical research into primary care settings email listserv to receive periodic updates on program planning and activities.