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CLINICAL & TRANSLATIONAL SCIENCE AWARDSCLINICAL & TRANSLATIONAL SCIENCE AWARDS
The Importance of Community EngagementThe Importance of Community Engagement
J. Lloyd Michener, MDProfessor and Chair
Director, Duke Center for Community ResearchDepartment of Community and Family Medicine
Duke University School of Medicine
Ohio State UniversityDepartment of Family Medicine
January 22, 2009
Re-engineering Clinical ResearchRe-engineering Clinical Research
BenchBench BedsideBedside PracticePractice
Building Blocks and Pathways•Molecular Libraries•Bioinformatics•Computational Biology•Nanomedicine
TranslationalResearchInitiatives
• Integrated Research Networks• Clinical Research Informatics • NIH Clinical Research Associates• Clinical Outcomes
Interdisciplinary Research Innovator Award
Public-Private Partnerships
Cross-cutting: Harmonization, Training
NIH Clinical and Translational Science Awards NIH Clinical and Translational Science Awards . . . and Beyond. . . and Beyond
Catalyze change - break silos, break barriers, and break conventions
Advance the new intellectual discipline of clinical and translational science
Integrate resources and training
Identify and remove impediments to clinical and translational science
Clinical and Translational Science Award (U54)
Trans-NIH collaboration
First RFA released October, 2005
reviewed in summer of 2006 for October 2006 funding
U54 mechanism
Cooperative agreement between awardee academic institution and NIH
Multi-faceted research program
Complex award mechanism: Combined U54, T32 and K12
5 year award
MT
WY
ID
WA
OR
NV
UT
CA
AZ
ND
SD
NE
CO
NM
TX
OK
KS
AR
LA
MO
IA
MNWI
IL IN
KY
TN
MS AL GA
SC
VAWV
MI
PANJ
MA
ME
VTNH
AK
HI
UC, Davis
Duke
UCSF
University of Rochester
OHSU
UT, Houston
Mayo Clinic
Columbia
Yale
OH
University of Washington
Emory
University of Iowa
University of Michigan
Washington University, St. Louis
Vanderbilt
Weill Cornell
FL
Since 2007
Since 2006
University of Chicago
RockefellerUniversity of Pennsylvania
Johns Hopkins
UT Southwestern
Case Western Reserve
NY
University of Wisconsin
Participating Institutions
University of Pittsburgh
Building a National CTSA Consortium
Stanford
Scripps
Univ. of Utah
Univ. of Colorado
HarvardBoston UniversityTufts University
OSU
UNC
Univ of Alabama at Birmingham
Indiana University
Northwestern
UT San Antonio
Albert Einstein
Since 2008
Trial Design
Advanced Degree-Granting
Programs
Participant& CommunityInvolvement
RegulatorySupport
Biostatistics
ClinicalResources
BiomedicalInformatics
ClinicalResearch
Ethics
CTSAAcademic Center
NIH & other government
agencies
Healthcare organizations
IndustryIndustry
Key Functions
Strategic Planning
Goal One: Enhancing National Clinical and Translational Research Capability
clinical research management research infrastructure phenotyping - human and preclinical models
Goal Two: Enhancing the Training and Career Development of Clinical and Translational Scientists
Strategic Planning
Goal Three: Enhancing Consortium-Wide Collaborations
National Resource Inventory Data Sharing Network Social Networking Initiative
Goal Four: Enhancing the Health of Our Communities and the Nation
National Model for Community Engagement Inform Public Health Policy Through Research
Consortium Governance & Organization
Governance Manual available at http://ctsaweb.org/Docs/CTSA_Governance_Manual.pdf
Recent CTSA Community Engagement Activities
Established 4 topic-based workgroups:
Community-Based Academic and Practice partnership Workgroup
Education Workgroup Resource Development Regional Workshops Workgroup
Workshop May 9, 2008 in Bethesda, MD: “Accelerating the Dissemination and Translation of Clinical Research into Practice”
May 14-15, 2009 NIH workshop: “Improving Health WITH Communities: The Role of Community Engagement in Clinical and Translational Research”
5 Regional Workshops 2008 Jointly Sponsored by NCRR and APTR/CDC:
Supplemental ProjectsConsultation Service
Provide consultation for each CTSA to strengthen community practice links
PRIMER
Practice network research infrastructure needs among CTSAs
Recent CTSA Community Engagement Activities
CTSAWeb.org
The Duke Center for Community Research (DCCR)Moving the Community from Subject to
Collaborative Partner Goal:
Improve the health of the community through:
Community engagement in research
Integration of practices into research structure
Linking communities, practices, researchers
Components:
1. Community Research Liaison Center
2. Community Health Research Training Center
3. Electronic Health Record
4. Demonstration Projects
DTMI Faculty Leadership
DTMI Administration
DCCRDCRIDTRI
Oddone (K30), Bastian (T32), Hamilton (K12)
McKinney, Burks, McHutchison, Turner
Cuffe, McKinney, Szczech
St. Geme, Li, Benjamin
Cooke-Deegan, Beskow
George
Pietrobon, Krishnan, Ahmad, Cuttechia
Ginsburg, Weinhold, Kurtzberg, Guilak, Charles, Dewhirst, Toone, Hauser
Gilliss
Sullenger Harrington, Schulman, Peterson, McHutchison
Michener, Yaggy,Gilliss, Miranda
DTMI Administration
DCCRDCRIDTRI
Oddone (K30), Bastian (T32), Hamilton (K12)
McKinney, Burks, McHutchison, Turner
Cuffe, McKinney, Szczech
St. Geme, Li, Benjamin
Cooke-Deegan, Beskow
George
Pietrobon, Krishnan, Ahmad, Cuttechia
Ginsburg, Weinhold, Kurtzberg, Guilak, Charles, Dewhirst, Toone, Hauser
Gilliss
Sullenger Harrington, Schulman, Peterson, McHutchison
Michener, Yaggy,Gilliss, Miranda
DTMI Administration
DCCRDCRIDTRI
Education and Training
DCRU
Duke as a Site
Pediatrics
Ethics
Biostatistics
Biomedical Informatics
Core Laboratories
Nursing
New molecule
Preclinical dev.
First-in-human
Phase II/III
Application in the communityNew molecule
Preclinical dev.
First-in-human
Phase II/III
Application in the community
DTMI Organizational Structure DTMI Faculty Leadership
DTMI Administration
DCCRDCRIDTRI
Oddone (K30), Bastian (T32), Hamilton (K12)
McKinney, Burks, McHutchison, Turner
Cuffe, McKinney, Szczech
St. Geme, Li, Benjamin
Cooke-Deegan, Beskow
George
Pietrobon, Krishnan, Ahmad, Cuttechia
Ginsburg, Weinhold, Kurtzberg, Guilak, Charles, Dewhirst, Toone, Hauser
Gilliss
Sullenger Harrington, Schulman, Peterson, McHutchison
Michener, Yaggy,Gilliss, Miranda
DTMI Administration
DCCRDCRIDTRI
Oddone (K30), Bastian (T32), Hamilton (K12)
McKinney, Burks, McHutchison, Turner
Cuffe, McKinney, Szczech
St. Geme, Li, Benjamin
Cooke-Deegan, Beskow
George
Pietrobon, Krishnan, Ahmad, Cuttechia
Ginsburg, Weinhold, Kurtzberg, Guilak, Charles, Dewhirst, Toone, Hauser
Gilliss
Sullenger Harrington, Schulman, Peterson, McHutchison
Michener, Yaggy,Gilliss, Miranda
DTMI Administration
DCCRDCRIDTRI
Education and Training
DCRU
Duke as a Site
Pediatrics
Ethics
Biostatistics
Biomedical Informatics
Core Laboratories
Nursing
New molecule
Preclinical dev.
First-in-human
Phase II/III
Application in the communityNew molecule
Preclinical dev.
First-in-human
Phase II/III
Application in the community
DTMI Organizational Structure
Regulatory Affairs
Project Leaders and the Portal Office
1. Community Research Liaison Center The connection between Duke and local
communities, practices, and organizations
A virtual library:
For researchers to learn about communities
For community groups to learn about themselves
For practices to identify opportunities for improvement Outreach and training to assist communities with data and to
connect communities with researchers
Status: 23 grants funded, submitted or under development
14 community-wide health committees staffed
2. Community Health Research Training Center
Train and prepare researchers and learners to work successfully with communities
• Electronic training modules
• On-site training programs
Status: required training for clinicians and researchers begun with online modules and classes (2500 trained to date)
www.aamc.org/mededportalgo to “Find Resources”; enter keyword: community engaged research
3. Electronic Health Record Covers citizens of Durham County
Captures data for Durham County
Develop analytic techniques
Data capture and co-variates
Meshing advanced laboratory data with long term outcomes
Produce improvement of community health status
Status: Implemented in Duke practices, data analyses underway with community partners
4. Demonstration Projects Pilot projects to see if teams of community groups,
clinicians, and researchers can improve health
$ 1 million for 1 year for planning
RFA for pilot projects released Summer 2008. Requirements:
Input, support, and commitment from community Well-integrated design for prevention/care; Budget that demonstrates effective use of resources; Evaluation plan that establishes measurable markers
Project Status
Projects: Adolescent Health Asthma Breast Cancer Cancer Cardiovascular Disease Chronic Kidney Disease Diabetes Diabetes HIV/AIDS Insurance for Small Businesses Maternal/child health
Obesity (0-5) Obesity (Latinos) Obesity and Wellness Organ Donation Pain Management Prostate Cancer Seniors (Aging in Place) Seniors (Fall Prevention) Substance Abuse Substance Abuse (Youth) Youth Violence
Number of Proposals Received: 22Number of Team Members: 413
•Duke affiliated: 237 (57%)•Durham: 176 (43%)
Number of Community Agencies, Organizations, and Businesses Represented: 90
More information:
CTSA: http://www.ctsawiki.org/wiki Community Engagement Training Modules:
www.aamc.org/mededportal
go to “Find Resources”; enter keyword: community engaged research
Durham Projects: http://forms.dukehealth.org/dccr/dtmi.nsf/rfp
Michener JL, Yaggy S, Lyn M. Warburton S, Champagne M, Black MA, Cuffe M, Califf R, Gilliss C, Williams RS, Dzau VJ. Improving the Health of the Community: Duke’s Experience with Community Engagement. Acad Med. 2008; 83:408-413
Principles of Community Engagement CDC/ATSDR Committee on Community Engagement Centers for Disease Control and Prevention Public www.cdc.gov/phppo/pce
New Challenges Require New Solutions…
…Solutions that Combine Innovation with Community Engagement