1. U.S. Department of Health and Human Services National Institutes of Health NIH Roadmap: Re-engineering Clinical Research Enterprise Clinical Research Networks Update 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 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” Ensure that patients, physicians, and scientists form true “Communities of Research” NECTAR

3. 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: 1)Develop full inventory and database of clinical research networks (CRN) 2)Prepare detailed description of existing practices and selection of candidate best practices 3)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 An organization of clinical field sites and investigators that conduct multiple research protocols, often concurrentlyIncludes:  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 Forum May 31 and June 1, 2006 DoubleTree Hotel, Rockville, Maryland http://nihroadmap.nih.gov/publicmeetings.asp National Leadership Forum May 31 and June 1, 2006 DoubleTree Hotel, Rockville, Maryland http://nihroadmap.nih.gov/publicmeetings.asp Engage CRN leaders in building a common framework for dialogue on the NIH Roadmap initiative; present candidate “best practices” 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; Support cross-network exchange in the CRN community; Provide a springboard to ongoing dissemination of information and practice models to the CRN community. Provide a springboard to ongoing dissemination of information and practice models to the CRN community.

11. NIH Roadmap Networks Oversight Committee Lauren Aaronson, NINR Kenneth Buetow, NCI Penny Burgoon, OD Elaine Collier, NCRR Paul Eggers, NIDDK Kelly Fennington, OD Lawrence Fine, NHLBI Valery Gordon, OD Evan Hadley, NIA James Kiley, NHLBI (Chair) Cheryl Kraft, NIAID Charisee Lamar, NIAMS John Marler, NINDS Nancy Miller, OD Gregory Milman, NIAID Richard Morris, NIAID Amy Patterson, OD Bruce Pihlstrom, NIDCR Jody Sachs, NHLBI Susana Serrate-Stein, NIAMS Belinda Seto, NIBIB Scott Somers, NIGMS Robert Star, NCRR Betty Tai, NIDA Benedetto Vitiello, NIMH Josiah Wedgewood, NIAID Judith Whalen, NICHD Mark Willenbring, NIAAA

12. 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 Co-Chair: J. Kahn and S. Speedie  Education and Human Performance Strategies Chair: A. Morris

13. Summary  Inventory to provide current state of clinical networks and evaluate “best practices”  Network feasibility projects address varied:  Medical disciplines (cancer, heart, critical care, psychiatry, transplant)  Populations/settings (primary care, rural, minority, HMO)  Ages (pediatric, adult, geriatric)  Information systems (data standards, informatics, tools, platforms)  Geographic locations (U.S./Global)

14. NECTAR Future Plans

15. 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

16. Re-engineering the Clinical Research Enterprise in Discussion Inventory and Evaluation of Clinical Research Network (18 months) Feasibility of Integrating and Expanding Clinical Research Networks (3 years) FY2004 - FY2006FY2007- We are discussing how we might incorporate our acquired knowledge into a plan to benefit clinical research.

17. 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