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National Center forResearch 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 MedicineNovember 1, 2010
Anthony Hayward, MD PhDDirector, Division for Clinical Research,
National Center for Research Resources, NIH, USA
NCRR
Accelerating Research from Basic Discovery to Improved Patient Care is a shared goal
Improved patient care
Discovery and Mechanism
Technologies, Tools, and Resources
Clinical Studies
Community Engagement
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Pre-existing NIH awards that were combined:
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
= CTSA States= 2006–2009 CTSA Sites= 2010 CTSA Sites
MT
WY
ID
WA
OR
NV
UT
CA
AZ
ND
SD
NE
CO
NM
TX
OK
KS
AR
LA
MO
IA
MN
WI
ILIN
KY
TN
MS AL GA
FL
SC
VAWV
MINY
PA
MD
DE
NJCT
RIMA
ME
VTNH
AK
HI
NC
OH
PR
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CTSA – Assembling Local Participants
Yerkes National PrimateResearch Center
Kaiser PermanenteGeorgia
Atlanta VAMedical Center
Complex Carbohydrate Research Center
at U GeorgiaGeorgia BioGeorgia
Research Alliance
Emory University
Morehouse School of Medicine
CDC
GeorgiaTech
Children’sHealthcareof Atlanta
Atlanta Clinical and Translational Science Institute (Atlanta-CTSI) at Emory University
NCRR
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
Universityof Iowa
University of Chicago
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Assembling a Consortium: Developmental Milestones
2006 First 12 agree to work together and
ask NIH Clinical Center to join them 2006 9 Key Function Committees established 2008 First 24 start on Strategic Plan 2009 Strategic Goal Committees in place.
Number of Key Function Committeesexpands to 14
2010 Increased attention to administration, Consortium Management Committee
2011 March meeting to review products & goals
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Top Down or Bottom up?
CTSA Consortium Steering 80 Child Health Oversight 158 Biostatistics, Epidemiology, RD 141 Ethics 226 Clinical Research Management 216 Communications 110 Community Engagement 105 Comparative Effectiveness 105 Education, Career Development 176 Evaluation 132 Informatics 278 Public-Private Partnerships 101 Regulatory 187 Translational 123
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The CTSA consortium will enhance the efficiency and quality of clinical and translational research to improve the health of the nation
Each Strategic Goal Committee comprises 3 PIs and 3 administrators
Strategic Goals for the CTSA Program
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
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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
13
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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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Training Clinical and Translational ScientistsCore 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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CTSpedia Wiki structure Identifies and shares
resources across the national consortium and community researchers world-wide
ResearchMatch National recruitment Registry Centralized, disease-neutral
Web portal to connect researchers to research volunteers
Includes more than 40 CTSAs
REDCap Web-based tools Supports data
capture and dissemination for clinical and translational research
www.CTSpedia.org www.ResearchMatch.org www.project-redcap.org
Web Resources for Research Tools to Enhance Collaborations
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ResearchMatch.org – Connecting Volunteers with Researchers
National Web portal for research volunteers
• Registration for volunteers launched November 2009
• 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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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
Promoting Adolescent Health in Chicago Schools
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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
Panic anxiety model in rats finds increased orexin gene expression in neurons. An RNAi protects rats from symptoms
2nd pilot project grant funds clinical imaging in panic patients
Collaboration with U of Lund, Sweden finds higher levels of orexin in CSF of patients with panic anxiety than controls
Orexin antagonists may offer potential new treatment strategy
Grant support from NIMH and NCRR CTSA. Publication: Johnson PL, Truitt W, Fitz SD, Minick PE, Dietrich A, Sanghani S, Träskman-Bendz 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
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
Dr. Eric Topol (left), director of the Scripps CTSA and Gary West, a philanthropist
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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
University of California San Francisco Stanford University University of Pennsylvania Yale University – Pfizer Northwestern University Columbia University – Merck Washington University – Schering & Pfizer
Many CTSA sites have partnerships with industry:
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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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Challenges
Maintaining cohesion
• Between KFCs
• Between KFCs and PIs
Maintaining communication Sustaining tools and resources that originated
through supplements
Ensuring accurate reporting