2011 Articles

Reengineering the clinical research enterprise to involve more community clinicians

Kahn, Katherine; Pincus, Harold A.; Taylor, Stephanie; Quiter, Elaine; Cho, Michelle; Ryan, Gery; Berrebi, Claude; Beckett, Megan

The National Institutes of Health has called for expansion of practice-based research to improve the clinical research enterprise. This paper presents a model for the reorganization of clinical research to foster long-term participation by community clinicians. Based on the literature and interviews with clinicians and other stakeholders, we posited a model, conducted further interviews to test the viability of the model, and further adapted it. We propose a three-dimensional system of checks and balances to support community clinicians using research support organizations, community outreach, a web-based registry of clinicians and studies, web-based training services, quality audits, and a feedback mechanism for clinicians engaged in research. The proposed model is designed to offer a systemic mechanism to address current barriers that prevent clinicians from participation in research. Transparent mechanisms to guarantee the safety of patients and the integrity of the research enterprise paired with efficiencies and economies of scale are maintained by centralizing some of the functions. Assigning other responsibilities to more local levels assures flexibility with respect to the size of the clinician networks and the changing needs of researchers.