Development of a Conceptual Model and Assessment of the Feasibility of a National Clinical Research Associates Program: NCRA

A central aim of the National Institutes of Health’s (NIH’s) Roadmap for Medical Research is to reengineer the clinical research enterprise in ways that will accelerate and optimize the research process and the translation of resulting knowledge into improved healthcare and health outcomes. A critical ingredient for the success of this effort is a substantial increase in the availability of community clinicians who are willing and able, in a time- and cost-effective manner, to enroll patients in clinical trials. To address the shortage and relative lack of diversity of providers and patients participating in clinical research, the Roadmap calls for the development of a new program, the National Clinical Research Associates (NCRA), that would attract an unprecedented number of practicing providers to the field of clinical research (Zerhouni, 2003). Unlike in many existing research programs, “Associates” would participate in clinical research in the community, where the vast majority of Americans receive their care. Not only would this group of practicing clinicians involve and support a larger and more representative set of patients in NIH-funded research studies, but the proposed NCRA infrastructure would also greatly support NIH efforts to more efficiently and effectively tailor its research studies and findings to the needs of healthcare providers and the patients they serve.