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

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

Roadmap 0.8% ($237 Million) Non-Roadmap 99.2% ($28,520 Million)  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 NIH Roadmap for Medical Research

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

Research Teams New Pathways to Discovery Clinical Enterprise

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” Clinical Research Networks: NECTAR

NECTAR Inventory: current status of about 250 clinical research networks and best practices 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) NECTAR Inventory and Pilot Projects

 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 Transform Clinical Practice ImprovePopulationHealth EmpowerPatients NIH and the President’s Health Information Technology Strategic Plan

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. CTSA, NECTAR Pilot Projects and Inventory of Networks

 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 Translational Science Awards (CTSA)

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

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

NIH CTSAs: Home for Clinical and Translational Science Trial Design Advanced Degree-Granting Degree-GrantingPrograms Participant & Community Involvement RegulatorySupport Biostatistics Clinical Resources Biomedical Informatics ClinicalResearchEthics CTSAHOME NIH OtherInstitutions Industry

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

CTSA Funding Institutional Clinical and Translational Science Award RFA Approximately $30 M total to fund 4–7 awards in Sept 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

DCRR Budget Expenditures GCRCs CTSAs 247,191273,508283,747286,118293,157 * Careers19,67630,15230,84335,80435,508 SEPA15,96916,141 15,980 Other13,833 16,82920,54223,051 TOTAL296,669333,634347,560358,605367,696 (Thousands)* plus Roadmap funds

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

More Information Visit the following websites: Contact: Anthony R. Hayward, M.D., Ph.D. Director, Division for Clinical Research Resources National Center for Research Resources, NIH Telephone: Fax: More Information