G. Iris Obrams, M.D., M.P.H., Ph.D.

1. National Center for Research Resources G. Iris Obrams, M.D., M.P.H., Ph.D. NCRR Update 5 August 2006

2. NIH Roadmap: Re-engineering the Clinical Research Enterprise • From bench to bedside and from bedside to bench -- rapidly

3. NIH Roadmap for Medical Research • Developed to increase synergy across NIH • Not a single initiative but over 345 individual awards in FY 2005: • 40% basic • 40% translational • 20% high risk Non-Roadmap 99.2% ($28,520 Million) Roadmap 0.8% ($237 Million)

4. NIH Roadmap Strategy Interdisciplinary Research Training Clinical Research Associates Public Private Partnerships Bench Bedside Practice Clinical Research Informatics Pathways Molecular Libraries Bioinformatics Structural Biology Nanomedicine Integrated Research Networks Clinical outcomes Translational Research Initiatives

5. Clinical Enterprise

6. Clinical Research Networks: NECTAR • NIH Roadmap: National Electronic Clinical Trials and Research (NECTAR) Network • Link existing networks so clinical studies and trials can be conducted more effectively • Ensure that patients, physicians, and scientists form true “communities of research”

7. NECTAR Inventory and Pilot Projects • NECTAR Inventory: current status of about 250 clinical research networks and best practices http://www.ClinicalResearchNetworks.org • NECTAR Pilot Projects have broad coverage: • 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)

8. NIH and the President’s Health Information Technology Strategic Plan Transform Clinical Practice • Optimize Efficiency and Productivity of Biomedical Research • Basic exploration • Bioinformatics and computational biology • Accelerate research translation • Regional translational research centers • Research IT systems • NECTAR • caBIG • Vocabularies • Standards Interconnect Physicians Empower Patients Improve Population Health

9. CTSA, NECTAR Pilot Projects and Inventory of Networks • These are complementary programs: CTSA focuses on academic institutions as homes for research, NECTAR focuses on linking organizations together. • NECTAR Inventory identifies best practices for existing clinical network management. The NECTAR Pilot Projects explore how to combine and extend clinical networks. • CTSA builds the homes for clinical and translational science. CTSA emphasizes internal and inter-institution nationwide interoperable informatics.

10. Translational Science Awards (CTSA) • Recent biomedical discoveries demand an evolution of clinical science • CTSA awards will lower barriers between disciplines, and encourage creative, innovative approaches to solve complex medical mysteries • New prevention strategies and treatments must be brought into medical practice rapidly • The clinical and translational science awards are a way to catalyze change - breaking silos, breaking barriers, and breaking conventions

11. Clinical and Translational Science Awards • Create an institutional home and a distinct discipline for clinical and translational research at academic institutions • Facilitate transition from basic translational research to improved patient care and public health • Enhance interdisciplinary clinical and translational education and career development • Provide opportunities and resources for original research on novel methods • Develop translational technologies and a knowledge base for the full spectrum of clinical and translational science • Synergize partnerships with industry, foundations, and community physicians

12. Forming Clinical and Translational Science Homes Upgraded biostatistics Upgraded informatics Disease X Center Clinical Research Design Incubator IRB Upgraded regulatory advice GCRC NECTAR NCRA Translational cores Training Programs Disease Y Center NIH RAID Degree granting K30 Curriculum

13. NIH CTSAs: Home for Clinical and Translational Science NIH Other Institutions Clinical Research Ethics Trial Design Advanced Degree-Granting Programs Biomedical Informatics CTSA HOME Industry Participant & Community Involvement Clinical Resources Biostatistics Regulatory Support

14. Biostatistics and CTSA Key Functions • Performance of Innovative Translational Research Projects • Development of Clinical and Translational Methodologies and Technologies • Biomedical Informatics • Design, Biostatistics, and Clinical Research Ethics • Regulatory Support • Participant and Clinical Interactions Resources • Community Engagement • Education, Training and Career Development and capabilities for Pilot and Collaborative Studies

15. CTSA Funding Institutional Clinical and Translational Science Award RFA • Approximately $30 M total to fund 4–7 awards in Sept. 2006 • Length of awards 5 years • Up to $6 million in total costs per award per year in addition to combined current total costs of certain existing NIH awards (NCRR K12, K30, M01; Roadmap T32 and K12) • To be reissued annually for additional centers • Second RFA receipt date January 17, 2007 • Expand to ~60 awards by 2012, costing in aggregate up to $500 M • Funded by NIH Roadmap for Medical Research and existing NIH programs Planning Grant RFA for Institutional CTSAs • One-time solicitation for one-year award • ~50 awards, $150K direct costs; $11.5 M total

16. DCRR Budget Expenditures (Thousands) * plus Roadmap funds

17. Transformation of the GCRCs • GCRC reviews from now on conducted without site visits • Only GCRC applications with already scheduled submission date accepted • Last GCRC application submission date June 1, 2007 • Successful GCRC applications receive 3-year award • GCRCs with end date in 2008 may request 1-year extension • GCRCs at successful CTSA applicant institution will become part of the CTSA • Transformation process to CTSAs anticipated complete by September 30, 2010

18. More Information More Information Visit the following websites: http://nihroadmap.nih.gov/http://www.ncrr.nih.gov/clinicaldiscipline.asp Contact: Anthony R. Hayward, M.D., Ph.D.Director, Division for Clinical Research ResourcesNational Center for Research Resources, NIHTelephone: 301-435-0790Fax: 301-480-3661E-mail: haywarda@mail.nih.gov