Clinical and Translational Science Strategic Plan (CSP)

1. Clinical and Translational Science Strategic Plan (CSP) Just ideas for discussion…

2. Each academic health center will create a home for clinical and translational science NIH & other government agencies Clinical Research Ethics Trial Design Advanced Degree-Granting Programs Biomedical Informatics CTSA HOME Industry Clinical Resources Participant & Community Involvement Biostatistics Regulatory Support Healthcare organizations

3. Key orientation for CSP What can the consortium accomplish as a unified/federated organization beyond the impact of the individual sites?

4. Key Components of a Strategic Plan • Mission • Vision • Goals • Tactics • Manual of Operations (MOP) • Communication plan • Evaluation plan • Budget and funding

5. Clinical and Translational Science Awards • The Clinical and Translational Science Awards (CTSAs) is a consortium that is transforming how clinical and translational research is conducted, ultimately enabling researchers to provide new treatments more efficiently and quickly to patients. • The consortium is designed to: • Encourage the development of new methods and approaches to clinical and translational research • Improve training and mentoring to ensure that new investigators can navigate the increasingly complex research system • Design new and improved clinical research informatics tools • Assemble interdisciplinary teams that cover the complete spectrum of medical research • Forge new partnerships with private and public health care organizations

6. Who Cares about the CTSA CSP? • Primary Players: CTSA PI’s and NCRR • Key Partners • Consortium committees • NIH Institutes • Key constituents • Institutional officials for CTSA recipients • NIH leadership • Faculty at CTSA recipients • Rest of clinical and translational research world • Congress, industry, professional societies and organizations, the public, the press

7. Consortium Oversight Committee (COCC) • Responsible for driving the process of developing the CSP • Discussing on weekly conference calls • Organizing input/writing the plan • Deciding when iterations are needed with partners and constituents • Crafting penultimate version for approval by COCC

8. COCC Members • COCC Co-Chairs (currently Berglund and Califf) • NCRR leadership (currently Alving and Hayward) • PI members • NIH members

9. NCRR Role • Provides ideas and concepts for CSP • Discusses drafts of plan for iterative input • Has input into all aspects • Approves through COCC • Iteratively deals with consonance of plan with funding availability and allowable mechanisms of funding

10. PI Role • Provides ideas and concepts for CSP • Discusses drafts of plan for iterative input • Has input into all aspects, • Approves through COCC • Has key input into feasibility of implementation of vision given institutional opportunities and constraints • Monitors and communicates need for updates through COCC

11. Consortium Committees • Represented by Co-Chairs and PI liasons • Asked for input to vision and mission statements early on • Asked for ideas about key priorities and needs prior to “consortium wide retreat” • Review and comment on product of retreat • Review and comment on drafts of CSP

12. NIH Institutes • Represented by NIH appointed and PI liasons • Asked for input to vision and mission statements early on • Asked for ideas about key priorities and needs prior to “consortium wide retreat” • Review and comment on product of retreat • Review and comment on drafts of CSP

13. Thoughts on Key Constituents • Institutional officials • Existential issue of role of CTSA within institutions (transforming or “on the shelf”?) • Need to get these folks involved • NIH leadership • How do we deal with likelihood of new administration? • Importance of clear CTSA consensus on value • Faculty • We are challenged to assure that we are communicating effectively with our own faculty • This is a chance to do it

14. Thoughts on “Rest of World” • Congress, the press, the public • Communication methods very similar for these 3 elements • Should they be involved and how? • Professional organizations and professions • Too many to count • Should they be involved and how? • Industry • IT, devices, drugs, payers, providers, etc… • Prediction: private money will be more important no matter who gets elected so “rules of engagement” will be critical

15. Process for Strategic Plan • Use face to face meeting of COCC to begin discussion of mission, vision and goals • Retreat of operations committee shortly after face to face meeting • Ask each committee to come up with list of what it believes the consortium should be doing • “Big Bang” CSP retreat of PI’s and NCRR leaders with reps of other key constituents • Work towards plan agreement within 2 cycles of face to face meetings • Treat the CSP as a “living document”

16. Impetus for the CTSA Program • Implementing biomedical discoveries made in the last 10 years demands an evolution of clinical science. • New prevention strategies and treatments must be developed, tested, and brought into medical practice more rapidly. • CTSA awards will lower barriers between disciplines, and encourage creative, innovative approaches to solve complex medical problems. • These clinical and translational science awards will catalyze change -- breaking silos, breaking barriers, and breaking conventions.

17. Building a National CTSA Consortium WA ME MT ND VT MN OR NH ID WI NY MA SD RI WY MI CT NJ IA PA NE NV OH DE IN IL UT MD CO WV VA KS MO CA KY TN AZ OK AR SC NM GA AL MS TX LA AK FL HI Participating Institutions Since 2006 Since 2007

18. Building a National CTSA Consortium FY06 Grantees Center for Clinical and Translational ScienceThe Rockefeller University Center for Clinical and Translational SciencesUniversity of Texas Health Sciences Center at Houston Clinical and Translational Science CenterUniversity of California, Davis Clinical and Translational Science InstituteUniversity of Pittsburgh Clinical and Translational Science Institute University of California, San Francisco Clinical and Translational Sciences InstituteUniversity of Rochester School of Medicine and Dentistry Duke Clinical and Translational Science InstituteDuke University Institute for Translational Medicine and TherapeuticsUniversity of Pennsylvania Irving Institute for Clinical and Translational Research Columbia University Mayo Center for Translational Science ActivitiesMayo Clinic Oregon Clinical and Translational Research InstituteOregon Health and Science University (partnering with Kaiser Permanente) Yale Center for Clinical InvestigationYale University FY07 Grantees Atlanta Clinical and Translational Science Institute Emory University (partnering with Morehouse College) CTSA at Case Western UniversityCase Western University CTSA at Washington University Washington University CTSA at Weill Cornell Medical College Weill Cornell Medical College (partnering with Hunter College) Institute for Clinical and Translational ResearchUniversity Of Wisconsin Madison Institute for Clinical and Translational Research Johns Hopkins Institute of Translational Health Sciences University Of Washington Michigan Institute of Clinical and Health Research University Of Michigan At Ann Arbor North & Central Texas Clinical and Translational Science Initiative University of Texas Southwestern Medical Center - Dallas University Of Chicago CTSAUniversity Of Chicago Univ of Iowa's Inst for Clinical and Translational Science University Of Iowa Vanderbilt Institute for Clinical and Translational Research Vanderbilt University (partnering with Meharry Medical College)

19. Consortium Governance & Organization Governance Manual available at http://ctsaweb.org/Docs/CTSA_Governance_Manual.pdf

20. CTSAWeb.org

21. CTSA Publication Policy Initial Discussion

22. CTSA Publication Policy • Publications emanating from an individual CTSA • With direct CTSA funding of personnel • With infrastructure support • “CTSA associated”

23. CTSA Publication Policy • Publications reflecting opinions about CTSA

24. CTSA Publication Policy • Publications reflecting official view of CTSA Consortium • With NIH and PI participation • With NIH, but not PI participation • With PI, but not NIH participation