1. A Vision for Clinical and Translational Research Presentation to the Clinical Research Seminar The University of Oklahoma Health Sciences Center Barbara Alving, M.D. Acting Director NCRR, NIH

2. Public Health Challenges
Acute to chronic conditions
Aging Population
Health Disparities
Emerging Diseases
Biodefense

3. The Research Enterprise
Basic Research
Applied Research
Clinical Investigations and Trials
Demonstration and Education Research
Knowledge Acquisition
Knowledge Validation
Knowledge Transfer
Knowledge Dissemination
Health of the Nation

4. Challenges to Interdisciplinary Research
The current system of academic advancement favors the independent investigator
Most institutions house scientists in discrete departments
Interdisciplinary research teams take time to assemble and require unique resources
a single PI is recognized; indirect costs from collaborating institutions become embedded in direct costs of the “lead” institution indirect costs follow the PI.

5. Why a Roadmap? Accelerated pace of discoveries in the life sciences
Need for their more rapid translation into practice
Opportunities to build an integrated system that is far more effective than current approaches

6. The Three Themes of the NIH Roadmap for Medical Research
New Pathways
to Discovery
Research Teams
of the Future
Re-engineering the
Clinical Research
Enterprise

7. Re-engineering Clinical Research
Interdisciplinary
Research
Innovator Award
Public-Private Partnerships
Bench
Bedside
Practice
Building Blocks
and Pathways
Molecular Libraries
Bioinformatics
Computational
Biology
Nanomedicine
Integrated Research Networks
Clinical Research Informatics
NIH Clinical Research Associates
Clinical Outcomes
Translational
Research
Initiatives
Cross-cutting: Harmonization, Training

8. Major Shifts in Priorities at AHCs
Explosion in clinical service demands and reduction in financial margins side-lines the training of clinician scientists
Marked increase in numbers of faculty leads to a “dilution” effect with a decreasing valuation attached to translational and clinical sciences
The complexity of knowledge needed to be an effective translational scientist is not easily acquired
Young clinical faculty have trouble finding a real “HOME” for their aspirations

9. A Transforming Goal:
Provide the academic home and integrated resources needed to advance the new intellectual discipline of clinical and translational sciences, create and nurture a cadre of well-trained investigators, and advance the health of the nation by transforming patient observations and basic discovery research into clinical practice

10. Clinical and Translational Science Awards (CTSA)
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

11. Where are we starting from?
Training
Programs
K30
Curriculum
GCRC
Disease X
Center Y

12. Missing Pieces needed to form a Home for Clinical and Translational Sciences
Upgraded
biostatistics
Upgraded
informatics
Disease X
Center
Clinical
Research
Design
Incubator
IRB
GCRC
Upgraded
regulatory
advice
NECTAR
NCRA
Translational
cores
Training
Programs
Disease Y
Center
NIH
RAID
Degree
granting
K30
Curriculum

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

14. New Programs Will Support Different Experimental Models and Approaches
Research-Intensive AHC Small AHC
Need
Have
Flexible programs with adjustable sizes for different needs

15. How is this transformation achieved?
Through the NIH Roadmap for Medical Research, create an integrated environment for the clinical and translational researcher that can provide:
an academic home for clinical research (a Center, Department, or Institute [C/D/I])
support for protocol preparation, regulatory compliance, and data management
support for participant recruitment, human subject safety monitoring
education leading to advanced degrees in clinical research
specialized cores and services for translational research

16. Definitions
Clinical Research covers all studies of diseases and trials of treatments that take place in human subjects.
Translational Research describes the steps between a fundamental discovery and its application in clinical medicine.
Needed to support tasks at large institutions
INCLUDES ACADEMIC COMPONENT AND SERVICE

17. CTSA Eligibility
Domestic institutions, universities, academic health centers, or other organizations conducting clinical and translational research may apply.
Partnerships with independent and other research institutions are strongly encouraged.
Institutions can only submit, or be part of, a single application.

18. CTSA Eligibility
A graduate school accredited to award higher degrees in clinical research must be included.
The graduate school could be at an affiliate rather than the applicant institution. Prior awarding of higher degrees in clinical research (MS, PhD) is expected.
By requiring a degree-granting academic program, NIH expects to create en environment that will foster the development of clinical and translational science as a distinct discipline

19. CTSA Eligibility
The opportunities offered through a CTSA should be wide ranging. Participation by multiple schools (e.g., nursing, pharmacy, dentistry, engineering—to name a few) and partnerships with independent and other research institutions are strongly encouraged.

20. FY 2006 CTSA Funding Opportunities
RM : Institutional Clinical and Translational Science Award RFA
RM : Planning Grant RFA for Institutional CTSAs
an academic home for clinical research (a Center, Department, or Institute [C/D/I])
support for protocol preparation, regulatory compliance, and data management
~50 awards, $150K direct costs; $11.5 M total
? Increase later on to average size of other program…

21. CTSA Funding
Up to $6 million in total costs per year in addition to combined current total costs of certain NIH awards
NCRR: K12, K30, M01 (GCRC)
Roadmap: T32 and K12
Approximately $30 M to support 4 –7 awards in FY 2006, in addition to amounts from existing awards
Length of awards: 5 years
Plan to expand to 60 awards, costing in aggregate up to $500 M, by 2012

22. How to Construct a CTSA Budget
New CTSA
Budget
T32 Slots
T32
K12
U54
Existing components
K12 Slots
Curriculum
Cores
Trainee Slots
Curriculum
Pilot Projects
Governance
Design/Stat/Ethic RM
NIH
NCRR
T32
K30
K12
GCRC
Community
Cores, Clinical
Translational
Two implementation issues
How to construct
Size
Where is money coming from
Transition existing resources into an integrated program
Pilot Projects
Regulatory
Governance

23. FY 2006 Timeline for Planning Grants and CTSAs
October 12, 2005: Published RFAs (CTSA
and Planning Grant)
October 17, 2005: CTSA Pre-Submission Meeting
December 7, CTSA Technical Grant Writing
Workshop
February 27, 2006: Letters of Intent Due
March 27, 2006: Applications Due
Summer 2006: Review Applications
September 2006: Fund Grants

24. More Information