By developing and training a cadre of community practitioners, NIH seeks to enhance the efficiency of clinical research networks and extend the generalizability of the results obtained in these studies. The National Clinical Research Associates (NCRAs) will function as clinical investigators by participating in clinical research in a practice setting, in the context of delivering health care. The NCRAs will participate in clinical studies, assist in patient recruitment, administer experimental treatments, report data, and be among the first to integrate new research findings into routine healthcare delivery. The NCRAs will be a diverse group of qualified healthcare practitioner-researchers who are well trained to ensure responsible conduct of clinical research. They will comprise a stable component of the clinical research infrastructure, ensuring that new infrastructure need not be recreated to accommodate each new research project. NIH envisions that the NCRAs, which will include practicing physicians, dentists, and nurse practitioners, will enroll and follow patients in clinical research projects that include multi-center clinical trials. The NCRAs might be members of an ongoing clinical research network that conducts several studies over time, or they may comprise an independent pool of practitioners through whom new clinical research projects recruit patients. The studies may focus on a single intervention or disease, or they may be more diverse in subject matter.

The first phase of the development of this program will be a contract to establish a conceptual model for the NCRA program and to assess its feasibility. An implementation plan will be developed to recommend a series of pilot projects to test the feasibility of recruiting and retaining NCRAs, as well as to suggest strategies for scaling up the program. A panel of experts will work with NIH program staff to provide input and analysis on the design of the feasibility assessment and on the emerging and final study findings.

NIH anticipates that the NCRAs will be healthcare practitioners primarily based in community practices or community hospitals that are not affiliated with academic medical centers, although they may have privileges at hospitals that have university affiliations (even though they do not have university appointments). NIH expects that the NCRAs will be mainly working in primary care settings (e.g., family medicine, pediatrics, internal medicine, obstetrics/gynecology) or in a limited range of specialties. To train the NCRAs, NIH anticipates creating several nationally recognized regional Centers of Excellence in Clinical Research Training modeled on the results of the feasibility and pilot studies. These centers will use an integrated approach to conduct training in real-world settings. Other efforts will focus on the establishment of national core competencies, which would include relevant board certification; knowledge of clinical research design and implementation and conflict-of-interest regulations; and documentation of training in protecting participants in clinical trials.

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