1. Clinical and Translational Science Awards (CTSAs): Building Connections February 4, 2009 National Advisory Council on Drug Abuse Barbara Alving, MD, MACP Director National Center for Research Resources NATIONAL INSTITUTES OF HEALTH A c c e l e r a t i n g a n d e n h a n c i n g r e s e a r c h f r o m b a s i c d i s c o v e r y t o i m p r o v e d p a t I e n t c a r e

2. Clinical Community National Center for Research Resources Accelerating research from basic discovery to improved patient care Improved patient care Pre-clinical Animal model resources imaging & informatics advances Clinical research support community engagement

3. Impetus for the CTSA Program CTSAWeb.org  Implement biomedical discoveries  Develop, test, and bring new prevention strategies into medical practice more rapidly  Catalyze change - lower barriers between disciplines  Encourage creative and innovative approaches To ensure new discoveries lead to improved public health, clinical science must evolve to better:

4. CTSAs – Building a National Consortium of Academic Health Centers Members 2006 & 2007 Participating Institutions WA OR CA NV AZ NM MT UT WY CO SD ND NE KS OK TX AK AR MO IA MN WI IL IN MI OH KY TN MS AL GA FL LA NC SC VA WV PA NY VT NH ME MA DE MD RI ID HI NJ PR New Members 2008 CT Currently 38 CTSAs Sites Across the Country

5. CTSA – Providing Local Leveraging Opportunities Yerkes National Primate Research Center Kaiser Permanente Georgia Atlanta VA Medical Center Complex Carbohydrate Research Center at U Georgia Georgia Bio Georgia Research Alliance Emory University Morehouse School of Medicine CDC Georgia Tech Children’s Healthcare of Atlanta Atlanta Clinical and Translational Science Institute (Atlanta-CTSI) at Emory University

6. CTSA – Creating National Partnership Opportunities Consortium Governance www.ctsaweb.org Advisory: providing guidance and input to the NCRR Director Oversight: identifying and selecting collaborative opportunities to facilitate research, coordinating Consortium-wide approaches to research, and overseeing topic- specific efforts across the Consortium Steering: coordinating institutional topic-specific efforts with the national CTSA Consortium; each Steering Committee has an Operations subgroup that takes timely action on emergent topic issues

7. CTSA National Strategic Plan Priorities Goal One:  Enhancing National Clinical and Translational Research Capability  Clinical research management  Research infrastructure  Phenotyping – human and preclinical models Goal Two:  Enhancing Training and Career Development of Clinical and Translational Investigators Goal Three:  Enhancing Consortium-Wide Collaborations  Social networking  Inventory of resources  Data sharing Goal Four:  Enhancing the Health of Our Communities and the Nation  Community engagement  Public health policy

8. CTSA – Creating National Partnership Opportunities Working as a Consortium, we have established a committee structure to execute the vision and goals of the CTSA program

9. CTSAweb.org Resources for Researchers Building Connections e-Newsletter Communication Toolkit

10. CTSA – Creating Regional Partnership Opportunities = CTSA Institutions = East Coast Consortium = Midwest Consortium = West Coast Consortium Weill Cornell Medical College Columbia University Rockefeller University Albert Einstein College of Medicine University of Rochester Yale University University of Wisconsin Mayo Clinic College of Medicine University of Washington Oregon Health & Science University University of California, Davis University of California, San Francisco Stanford University The Scripps Research Institute Washington University in St. Louis University of Iowa University of Chicago

11. Encouraging and Enhancing Collaboration CTSA Consortium – Informatics Pilots  Implementation and development of tools for clinical investigators to facilitate small and medium sized research studies  Enhance the collection and management of data in small and medium sized studies  Requirements  At least three CTSA must collaborate  Data and software sharing  Must incorporate institutional database support that is flexible, secure, and easily accessible on demand Clinical and Translational Information Exchange Environment Informatics Pilots

12. Informatics Pilot Projects PhysioMIMI at Case Western Reserve University  Includes investigators from Marshfield Clinic, University of Wisconsin and University of Michigan  Collects, manages, and analyzes diverse data types across institutions  Allows secure, safe and regulated transfer of information from clinical care systems and research databases Sharing Clinical Data at University of Washington  Includes investigators from University of California, San Francisco, University of California, Davis  Allow researchers to access large shared datasets  Assist with designing research studies and generating hypotheses Research Electronic Data Capture (REDCap) at Vanderbilt  Includes investigators from Oregon Health and Sciences University and Mayo Clinic  Provide an easy way for researchers to develop a secure, web-based application for collecting, managing and sharing of their clinical and translational research data  Create secure and flexible interoperability between REDCap and external data systems thus ensuring data quality in information exchange

13. Informatics Pilots WA OR CA NV AZ NM MT UT WY CO SD ND NE KS OK TX AK AR MO IA MN WI IL IN MI OH KY TN MS AL GA FL LA NC SC VA WV PA NY VT NH ME MA DE MD RI ID HI CT NJ PR University of California, Davis University of California, San Francisco Mayo Clinic College of Medicine University of Washington Vanderbilt University Case Western Reserve University Mansfield Clinic University of Wisconsin– Madison Oregon Health & Science University University of Michigan

14. CTSA Consortium – Building Connections with Business Schools  Develop business plans, design, and implement community surveys  Create innovative cross-educational programs  Develop case studies to pilot programs  Collaborate with international colleagues  Prepare cost analyses  Protect CTSA-developed patents  Form industry partnership programs CTSA are partnering with business schools to:

15. Encouraging and Enhancing Collaboration NIH Opportunities CTSA Thematic Research Networks/CTSA Interest Groups  Emergency Medicine  Sleep Research Network  Critical Care  Neurology  Neuroimaging

16. Educational Impact of CTSA Program  Doubled the clinical and translational training workforce from 2006 - 2008  Increased the number of regional training interactions among consortium sites  Awarded a supplement to develop a National CTSA Educational Resource Program (NCERP) that will:  Identify, catalog, and assess training modules in clinical and translational research  Enhance and broaden training opportunities for clinician- scientists across the CTSA consortium

17. Educational Impact of CTSA Program (Based on 2008 Annual Progress Reports from first 24 CTSAs) Clinical Disciplines (includes 37 subcategories) Pediatric Disciplines Public Health Stats, Res Methods, Informatics Genetics Allied Health Immunology Nursing Bioengineering Neuroscience Psychology, non-clinical Physiology Microbiology and Infect Diseases Pharmacology Molecular Biology Other Total 3,948 516 317 176 134 121 115 110 108 93 77 69 61 53 ____250 6,256 272 29 50 10 9 16 7 20 10 18 5 8 10 7 _____37 513 Field of Training # of Investigators # of Trainees and Scholars

18. CTSA Consortium and NIDA Collaborations (Based on 2008 Annual Progress Reports from first 24 CTSAs) Columbia University Health Sciences8 Emory University1 Johns Hopkins University19 Oregon Health and Science University2 Rockefeller University3 University of California San Francisco2 University of Chicago3 University of Pennsylvania8 NIDA Grants Utilizing CTSAs

19. CTSA Consortium and NIDA Collaborations (Based on 2008 Annual Progress Reports from first 24 CTSAs) University of Texas Health Science Center Houston3 University of Texas SW Medical Center Dallas3 University of Washington1 University of Wisconsin Madison1 Vanderbilt University3 Washington University2 Weill Medical College of Cornell University2 Yale University29 Total 90 NIDA Grants Utilizing CTSAs

20. NIDA Clinical Trials Network  Established in 1999 to conduct research in a wide variety of community based treatment programs across the United States.  Provides a unique opportunity to address a variety of underserved populations, and in particular to evaluate access to and effectiveness of treatments for ethnic minorities.  Seeks to reduce barriers to all its studies and has attended carefully to recruitment and retention of women and ethnic minority groups. Clinical Trials Network (CTN)

21. Opportunities for Partnership with CTSAs and NIDA Clinical Trials Network

22. Funding Opportunities at NIDA

23. National Center for Research Resources www.ncrr.nih.gov Translating Research from Basic Discovery to Improved Patient Care