Transcript Document

National Center for
Research Resources
NATIONAL INSTITUTES OF HEALTH
Translating research from basic discovery to improved patient care
The United States National Institutes of Health
Clinical and Translational Science Award
Program: An Overview
JCSMR First International Conference on Translational Medicine
November 1, 2010
Anthony Hayward, MD PhD
Director, Division for Clinical Research,
National Center for Research Resources, NIH, USA
Accelerating Research from Basic Discovery
to Improved Patient Care is a shared goal
Technologies,
Tools, and
Resources
Community
Engagement
Improved
patient care
Clinical
Studies
Discovery and
Mechanism
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CTSAs – Creating a Home for Clinical
and Translational Science
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Pre-existing NIH awards that were combined:
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General Clinical Research Centers
Mentored Career Development awards
Curriculum Development awards
Predoctoral Training awards
• Postdoctoral training awards
Successful applicants received about 40%
additional funding to support larger scope
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Building a National CTSA Consortium
55 CTSA sites in 28 states and the District of Columbia
WA
MT
ME
ND
VT
MN
OR
ID
NH
WI
SD
NY
MI
MA
RI
CT
WY
IA
NE
NV
PA
IL
UT
IN
OH
CO
DE
WV
KS
CA
MO
NJ
VA
KY
MD
NC
AZ
OK
TN
AR
SC
NM
MS
AL
GA
TX
LA
AK
FL
HI
PR
= 2010 CTSA Sites
= 2006–2009 CTSA Sites
= CTSA States
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NIH funding to successful CTSA applicants
1.6E+09
1.4E+09
1.2E+09
1E+09
800000000
600000000
400000000
200000000
0
94 91 88 85 82 79 76 73 70 67 64 61 58 55 52 49 46 43 40 37 34 31 28 25 22 19 16 13 10 7 4 1
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CTSA – Assembling Local Participants
Atlanta Clinical and Translational Science Institute (Atlanta-CTSI)
at Emory University
Kaiser Permanente
Georgia
CDC
Yerkes National Primate
Research Center
Morehouse
Children’s
Georgia
Emory
School of
Healthcare
Tech
University
Medicine
of Atlanta
Complex Carbohydrate
Research Center
at U Georgia
Atlanta VA
Medical Center
Georgia
Research Alliance
Georgia Bio
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An Extravert CTSA with Focus on Impact
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CTSA – Creating Regional Partnership Opportunities
University of
Washington
Oregon Health &
Science University
University of
California, Davis
University
of Iowa
Mayo
Clinic
College of
Medicine
University
of
University of Wisconsin Chicago
University of
Rochester
Yale University
Weill Cornell Medical College
Columbia University
University of
California,
San Francisco
Rockefeller University
Albert Einstein
College of Medicine
Stanford
University
= CTSA Institutions
= East Coast Consortium
The Scripps
Research Institute
= Midwest Consortium
= West Coast Consortium
Washington
University
in St. Louis
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Assembling a Consortium: Developmental Milestones
 2006
 2006
 2008
 2009
 2010
 2011
First 12 agree to work together and
ask NIH Clinical Center to join them
9 Key Function Committees established
First 24 start on Strategic Plan
Strategic Goal Committees in place.
Number of Key Function Committees
expands to 14
Increased attention to administration,
Consortium Management Committee
March meeting to review products & goals
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Top Down or Bottom up?
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CTSA Consortium Steering
Child Health Oversight
Biostatistics, Epidemiology, RD
Ethics
Clinical Research Management
Communications
Community Engagement
Comparative Effectiveness
Education, Career Development
Evaluation
Informatics
Public-Private Partnerships
Regulatory
Translational
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Strategic Goals for the CTSA Program
The CTSA consortium will enhance the efficiency
and quality of clinical and translational research to
improve the health of the nation
 Build national clinical and translational research
capacity
 Train and foster career development of clinical and
translational scientists
 Enhance consortium-wide collaboration efforts
 Bring new communities into research programs
 Encourage & promote bench to bedside (T1)
translational research
Each Strategic Goal Committee comprises 3 PIs and 3
administrators
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Build national clinical and translational
research capability
• Reducing protocol start-up times
• Measure and compare review times at all CTSAs
• Measure and compare contracting times
• Provide speedy and coordinated response to national needs
(e.g., vaccine trials, H1N1 epidemic)
• Reducing enrollment times
• Data from individual studies and clinicaltrials.gov
• Bring new communities into research
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CTSA Training & Career Development Pathways
Curriculum development component funded through
CTSAs:
Pre-doctoral Trainee component
• Supports 355 trainees
• Year-out research experience for medical students
• 5 year support for pre-doctoral students
• 3 year support for post-doctoral students
Post-doctoral component
• Supports 403 scholars
• Mostly “professional” doctorates, MD, DDS, DNP
• Mentored career development for post-doctoral
students with option for MS, MPH and PhD higher
degrees
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Educational Impact of CTSA Program
(Based on 2010 Annual Progress Reports from 46 CTSAs)
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Training Clinical and Translational Scientists
Core Competencies in Clinical and Translational Research
 Identify major clinical/public health problems and relevant
research questions
 Critique the literature regarding the status of a health
problem
 Design a study protocol for clinical and translational research
 Study methods, design and implementation
 Laboratory, clinical and population research methods
 Statistical methods and analysis
 Bioinformatics
Additional information available at
http://www.ctsaweb.org/corecompetencies
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Web Resources for Research Tools to
Enhance Collaborations
CTSpedia
 Wiki structure
 Identifies and shares
resources across the
national consortium
and community
researchers worldwide
www.CTSpedia.org
REDCap
ResearchMatch
 National recruitment Registry Web-based tools
 Centralized, disease-neutral  Supports data
capture and
Web portal to connect
dissemination for
researchers to research
clinical and
volunteers
translational
 Includes more than 40
research
CTSAs
www.ResearchMatch.org
www.project-redcap.org
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ResearchMatch.org – Connecting Volunteers with
Researchers
 National Web portal for research volunteers
• Registration for volunteers launched
November 2009
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• Researcher matching opened March 2010
More than 50 CTSA affiliated institutions participating
Over 100 studies registered
68 researchers have connected with 3,975 volunteers
by email
Of those contacted 20% responded yes they wish to be
contacted by the researcher
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Activities in Community Engagement
 Engage Communities and Enhance Trust
• CTSA community advisory boards link Academic Health
Center and communities
• Community engagement cores build capacity
 Facilitate Recruitment and Retention Efforts
 Share and Disseminate Best Practices
• Consultant services
• Publish “Principles of Community Engagement” booklet
• Define Community engagement core competencies
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Comparative Effectiveness Research
 Develop capacity and methods for translation of research
results into practice across the health care system
 Conduct a capacity and needs assessment of comparative
effectiveness research and related resources throughout
the CTSAs to help articulate how the consortium can act
as a portal to facilitate such research
 Expand the workforce of clinical researchers competent to
design, implement and analyze comparative effectiveness
research.
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Promoting Adolescent Health in Chicago Schools
 Promote HPV immunization of junior high school girls in
Chicago
 CTSA engaged underserved Chicago teenagers and parents
 Community Connections (CTSA Community Advisory
Research Board and church members) assisted in:
• Understanding community perspectives
• Determining awareness of potential risks and challenges
in community perceptions of HPV
• Building community support
 CTSA faculty bridged between investigators, community
leaders, and residents and the discussion of ethical issues
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Promoting translational research
• All CTSAs have a pilot project program
• Launched Pharmaceutical Assets Portal and IP Portal
• Partner with other trans-NIH activities:
• Molecular Libraries Probe Production Center Network
• Therapeutics for Rare and Neglected Diseases (TRND)
• Screening by National Center for Translational Technologies
• Next Translational Research meeting in March 2011
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A Pilot Project on Panic Anxiety
Project
Development
Team
Pilot Project
Grant –
translational
acceleration
program
Pilot project
grant –
clinical
translational
research
Research
findings
suggest new
medication
target
Helping to
Improve
treatments for
panic attacks
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Panic anxiety model in rats finds increased orexin gene expression
in neurons. An RNAi protects rats from symptoms
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2nd pilot project grant funds clinical imaging in panic patients
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Collaboration with U of Lund, Sweden finds higher levels of orexin in
CSF of patients with panic anxiety than controls
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Orexin antagonists may offer potential new treatment strategy
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Grant support from NIMH and NCRR CTSA. Publication: Johnson PL,
Truitt W, Fitz SD, Minick PE, Dietrich A, Sanghani S, TräskmanBendz L, Goddard AW, Brundin L, Shekhar A. A key role for orexin in
panic anxiety. Nat Med. 2010;16:111-5.
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Gravity Neutral Orthotic (GNO) Device for people with
severe physical disability
 Columbia CTSA pilot funded neurologist
Petra Kaufmann* built a device to help
children with spinal muscular atrophy
(SMA)
 Partnered with Elisa Konofagou, Ph.D.,
Assistant Professor of Biomedical
Engineering and Radiology
 Outcome: Patent IR 2380: Limb motion
capture and rehabilitative assist device
* = Currently Associate Director for Clinical Research at the
National Institute of Neurological Disorders and Stroke, NIH
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Wireless Technology to Monitor Patients with
Chronic Congestive Heart Failure
Scripps CTSA Pioneers Wireless Device
 Scripps Translational Science Institute with
Qualcomm develop wireless device that
monitors heart and breathing rates, fluid
status, posture and activity data in patients
with congestive heart failure
Dr. Eric Topol (left), director of
the Scripps CTSA and Gary
West, a philanthropist
 CTSA program connected Scripps to
Qualcomm and other technology firms
 A1,200-patient randomized clinical trial to
evaluate this wireless device (size of large
adhesive bandage) is in progress
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A Pharmaceutical Assets Portal
 A portal at UC Davis CTSA matches
investigators with “shelved”
pharmaceutical compounds that
can be repurposed for other
indications – such as rare diseases
 Has generated strong interest among both researchers
and pharma community
• Pfizer initiated agreement with UC Davis to further
develop Portal site
• UC Davis is also in talks with other industry groups
who also wish to list their available compounds
http://ctsapharmaportal.org
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CTSA Academic-Industry Partnerships
Many CTSA sites have partnerships with industry:
 University of California San Francisco
 Stanford University
 University of Pennsylvania
 Yale University – Pfizer
 Northwestern University
 Columbia University – Merck
 Washington University – Schering & Pfizer
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Evaluation
 Meeting the expectations of:
• Congress
• Other NIH Institutes and Centers
 With data from Annual Reports:
• Stories of Discovery
• Which Institute’s grants receive CTSA support
• Publications
• Trainees and their subsequent funding
• Patents
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Whose research gets CTSA support?
HL
CA
DK
MH
AI
NS
AG
HD
DA
AR
GM
AT
AA
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Whose research gets CTSA support?
3000
Awards from Diabetes/Kidney Institute from 2007-2009
2500
2000
Total
1500
Supported
1000
500
0
Non-Human
Human
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How many researchers get CTSA support?
4500
4000
3500
3000
2500
Total
Animal
2000
1500
1000
500
0
2005
2006
2007
2008
2009
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Histogram: number of publications in 2009
16
Number of CTSAs
14
12
10
8
6
4
2
0
0
50
100
150
200
250
300
350
400
Number of Publications
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Challenges
 Maintaining cohesion
• Between KFCs
• Between KFCs and PIs
 Maintaining communication
 Sustaining tools and resources that originated
through supplements
 Ensuring accurate reporting
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Future
 Please follow our progress at:
www.ctsaweb.org
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