Enhancing Translational Research Through the Clinical and Translational Science Awards AFMR 2007

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Enhancing Translational Research Through the
Clinical and Translational Science Awards AFMR
2007

• Barbara Alving, M.D.
• DirectorNCRR, NIH

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The Future Paradigm Transform Medicine from
Curative to Preemptive
Preemptive
Predictive
Personalized
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Rising U.S. Health ExpendituresBiomedical
research must be part of the solution
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National Health Expenditures as a Percent of GDP
Actual Projected
18
16
14
Percent of U.S. GDP
12
10
8
2012
2009
2006
2003
2000
1997
1994
1991
1988
1985
1982
1980
2015
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Balanced National Biomedical Research Portfolio
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The Three Themes of the NIH Roadmap for Medical
Research
New Pathways to Discovery
Re-engineering the Clinical Research Enterprise
Research Teams of the Future
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Clinical and Translational Science Awards

• 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

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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.

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CTSA Goals

• Develop novel designs for clinical trials
• Educate the next generation
• Build diversity in leadership
• Assemble interdisciplinary teams
• Enhance public trust
• Forge new partnerships with private and public
  health care organizations
• Create a national consortium

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NIH CTSA Award A Home for Clinical and
Translational Science
NIH
Clinical Research Ethics
Trial Design
Advanced Degree-Granting Programs
Biomedical Informatics
CTSA HOME
Industry
Participant Community Involvement
Clinical Resources
Other Institutions
Biostatistics
Regulatory Support
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First CTSA Awards Announced October 3

• 12 Academic Health Centers nationwide
• 52 planning grants to prepare applications to
  join consortium
• In 2012, approximately 60 institutions will be
  linked to energize clinical and translational
  science

NIH Funds a Dozen 'Homes' for Translational
Research
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Building A National CTSA Consortium FY 2006 CTSA
Awards Planning Grants
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Training and Career Development

• Core curriculum could include
• Biostatistics
• Bioethics
• Clinical trials design
• Informatics
• Health data standards
• Observational study design
• And more

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Training and Career Development Key components
of CTSA

• Features
• Graduate-granting and post graduate programs
• Diverse disciplines pediatrics, surgery,
  dentistry, pharmacology
• Includes study coordinators, project managers,
  key personnel
• Integrated and flexible research education
• Predoctoral training
• Career development environment

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Partnerships

• Food and Drug Administration (FDA)
• Center for Medicare and Medicaid Services (CMS)
• Data analysis, clinical trials
• Veterans Administration (VA)
• Informatics, clinical trials
• Public-Private Partnerships
• Developing better approaches for IP, cofunding
  large initiatives through the Foundation for the
  NIH

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Opportunities for Best PracticesCTSA Examples

• Rockefeller University
• Establish national research nursing standards
• Share research pharmacy best practices
• Collaborate with NIH Clinical Center to measure
  the experience of clinical research participants
• University of Pennsylvania
• Involve industry scientists in teaching and in
  training
• Bridge the pediatric/adult interface
• University of California, Davis
• Partner with schools of veterinary medicine,
  biological sciences, engineering, environmental
  sciences, and the state health care system in
  cross-disciplinary efforts
• Provide clinical consultations through novel
  telecommunications

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Examples of CTSA Activities

• Duke University
• Translate bench-bedside findings to populations
  using advanced informatics and health services
  delivery methods
• University of California, San Francisco
• Pursue new opportunities with the San Francisco
  VA and Kaiser Permanente
• Create new community research centers to expand
  efforts in minority and medically underserved
  populations
• Oregon Health and Science University
• Developing informatics capabilities to partner
  with Kaiser Permanente NW Center for Health
  Research, Oregon Rural Practice Research Network,
  Portland VA Medical Center for intervention
  research

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Informatics Challenges

• The challenges to the informatics community are
  to
• Adopt standards that can structure data,
  syntactically and semantically, from devices into
  the EHR and then into the longitudinal record
• Harmonize clinical informatics standards with
  research standards
• Work with research community to provide
  interactive clinical and research records.

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Examples of Cancer Bioinformatics Grid (caBIG)
Activities at CTSA Institutions

• Mayo Clinic and University of Pennsylvania
• Involved in caBIG architecture, data sharing and
  intellectual capital, strategic planning, tissue
  banks and pathology tools, and training
• University of Pennsylvania
• Involved in caBIG imaging initiative and
  clinical trial management systems
• Mayo Clinic
• Involved in caBIG vocabularies and common data
  elements

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Beyond the CTSA Consortium Opportunities for
Interaction with Diverse Communities

• CTSAs can develop partnerships with grantees at
  Research Centers in Minority Institutions (RCMIs)
  and in Institutional Development Award (IDeA)
  states
• Developing states and institutions offer
  geographically and ethnically diverse
  representation
• IDeA and RCMI grantees have track record in
  training and mentoring

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Research Centers in Minority Institutions 18
Centers in 10 States, the District of Columbia,
and Puerto Rico
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IDeA-Eligible States
23 statewide networks among universities and
colleges 73 thematic research centers
WA
ME
MT
ND
VT
MN
NH
OR
MA
ID
WI
NY
SD
RI
WY
MI
CT
PA
IA
NJ
NE
NV
OH
DE
IN
IL
UT
MD
CO
WV
VA
KS
DC
12
MO
CA
KY
NC
TN
AZ
OK
AR
SC
NM
GA
MS
AL
TX
AK
LA
FL
HI
PR
IDeA-Eligible States
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LARIAT
Connecting universities and researchers in the
rural west to advanced national
cyberinfrastructure for access to e-science
opportunities and informatics resources.
WA
ME
MT
ND
Montana State U.
U. of Idaho
VT
MN
NH
OR
MA
ID
WI
NY
SD
RI
WY
MI
U. Wyoming
CT
U. Nevada Reno
PA
IA
NJ
NE
NV
OH
DE
IN
IL
UT
MD
CO
WV
VA
KS
DC
12
MO
CA
KY
NC
TN
AZ
OK
AR
SC
NM
GA
AL
MS
U. Alaska
TX
AK
LA
FL
HI
PR
U. Hawaii
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The Future

• The CTSA consortium offers an unparalleled
  opportunity to disseminate standards and best
  practices that will guide both translational and
  clinical research and health care delivery
• The success of the CTSA consortium will be
  measured in part by the acceptance of its
  standards
• CTSAs will partner with geographically and
  ethnically diverse institutions that broaden
  their impact
• The ultimate goal continuous improvement in the
  health of populations and individuals throughout
  the nation

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Working as a Consortium http//ctsaweb.org/