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Re-engineering Clinical Research Networks for Effective Collaboration and Integration

This update from the NIH Roadmap discusses the feasibility of integrating and expanding clinical research networks to facilitate more effective clinical studies and trials. The goals include creating interoperable networks, providing informatics tools, streamlining oversight, improving patient safety, and enabling larger-scale research collaborations.

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Re-engineering Clinical Research Networks for Effective Collaboration and Integration

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  1. NIH Roadmap: Re-engineering Clinical Research Enterprise Clinical Research Networks Update U.S. Department of Health and Human Services National Institutes of Health Dr. Jody Sachs National Center for Research Resources April 18, 2006 Workshop Open Collaboration and Health IT Networking

  2. Feasibility of Integrating Clinical Research Networks • Link and expand existing networks so clinical studies and trials can be conducted more effectively • Ensure that patients, physicians, and scientists form true “Communities of Research” NECTAR

  3. NECTAR Goals: • Create interoperable “Network of Networks”; • Provide informatics tools for protocol prep, IRB mgmt, adverse event reports, data sharing; • Provide more efficient and effective research “business” practices and processes; • Streamline oversight and improve patient safety; • Rapidly translate research results; • Enable new research hypotheses through larger scale research collaborations.

  4. Network Feasibility Projects Long Range Goals: • To develop networks based on common infrastructure elements, e.g., informatics, governance, common language, and training activities, that conduct research in both academic and clinical care settings

  5. Program Examples: Informatics • Flexible infrastructure to manage clinical research “transactions” (NY) • Electronic toolbox to link multiple ICU’s to extend critical care research to practice (UT) • Tools to transfer complex genomic data from electronic medical records into a network database for research (SF) • Tools to harmonize methods derived from industry, academic and community based practice sites (PA)

  6. Inventory and Evaluation of Clinical Research Networks (IECRN) Major goals Inventory Contract: • Develop full inventory and database of clinical research networks (CRN) • Prepare detailed description of existing practices and selection of candidate best practices • Conduct national leadership forum to discuss findings and “Best CRN Practices”: May 31-June 1, 2006

  7. IECRN Web Database

  8. Inventory and Evaluation of Clinical Research Networks Inventory Status: • 250-300 fit definition of CRN • Core Surveys sent to 264 CRNs • Nominations for Best CRNs (40)

  9. Clinical Research Network Definition • An organization of clinical field sites and investigators that conduct multiple research protocols, often concurrently Includes: • Any research or data from Human Subjects relevant to improving the quality of human health; • Epidemiology, behavior modification, health communication, patient care, medical practice, clinical quality improvement, and clinical process improvement research.

  10. National Leadership ForumMay 31 and June 1, 2006DoubleTree Hotel, Rockville, Marylandhttp://nihroadmap.nih.gov/publicmeetings.asp • Engage CRN leaders in building a common framework for dialogue on the NIH Roadmap initiative; present candidate “best practices” • Support cross-network exchange in the CRN community; • Provide a springboard to ongoing dissemination of information and practice models to the CRN community.

  11. Roadmap Clinical Research Networks: Working Groups • Clinical Research Network Development Strategies Chair: K. Peterson • Human Subject Protection and Regulatory Strategies Chair: C. Dukes-Hamilton • Interoperability and Development Strategies Co-Chair: J. Kahn and S. Speedie • Education and Human Performance Strategies Chair: A. Morris

  12. NECTAR Future Plans

  13. Goals For Clinical Research Informatics • Reduced costs, startup time, overall duration, duplication for clinical trials • Increased public awareness and participation in clinical research • Enhanced access of clinical research data by researchers & regulatory organizations

  14. Re-engineering the Clinical Research Enterprise in Discussion FY2004 - FY2006 FY2007- Inventory and Evaluation of Clinical Research Network (18 months) We are discussing how we might incorporate our acquired knowledge into a plan to benefit clinical research. Feasibility of Integrating and Expanding Clinical Research Networks (3 years)

  15. Stakeholders • Federal: CMS, VA/DoD, FDA, ONC, AHRQ, HRSA, IHS, CDC, NIH, DHS • Public: Physicians, nurses, pharmacists, patients, participants, academic research centers • Industry: Pharmaceutical, device, hospitals, labs, health IT, CRO, insurance • NGOs: Foundations, associations, nonprofits

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