In response to BAA.RM.04.023, J. Richard Landis of the University of Pennsylvania (UPENN) Center for Clinical Epidemiology and Biostatistics (CCEB) is submitting this proposal entitled 'Harmonizing NIH and Industry Sponsored Clinical Research Network Architecture'. This feasibility project creates an organizational framework (investigators, clinicians, facilities and Office of Human Research (OHR) that contributes clinical research network re-engineering materials (standards, methodologies, and technology infrastructure) to a project framework of existing NIH and industry-sponsored Clinical Research Networks (CRNs). CRNs will apply essential re-engineering materials to improve, harmonize, and integrate research operations. OHR and CCEB hold unique institutional roles at UPENN that enable them to catalyze change across multiple CRNs using novel partnerships. Results will be disseminated by the Office of Human Research to NIH, UPENN, and the public, so that standardized materials and procedures may be employed by newly emerging CRNs. This microcosm represents a scalable, prototypical, re-engineered research enterprise architecture for the conduct of clinical research within a broad-based framework. The following five projects represent the objectives of this proposal. Each relies upon the existing Clinical Research Network and organizational framework described in the application: A - Develop Expert-Derived Clinical Research Network Re-Engineering Materials (CRN-REM), B - Establish Clinical Research Network Harmonization Methods Derived from Currently Merging NIH-Clinical Research Networks (two NIDDK-sponsored, multi-disease, multi-concurrent protocols, multi-canter CRNs), C - Establish Clinical Research Network Harmonization Methods Derived from an Industry-Funded Partnerships with an Academic Medical Center and Community-Based Practice Sites (first project undertaken is a large-scale, ten-year observational cohort study of rare pediatric disease outcomes), D - Integrate Emerging Clinical Research Network Re-Engineering Materials to an Existing, High-Visibility NIH Clinical Research Network (the NIDDK-sponsored Chronic Renal Insufficiency Cohort Study CRN), and E - Results Dissemination, Training, and Repeated Application (by the Office of Human Research, a responsibility ideally suited to this organization's role at the University of Pennsylvania).
