How Community Engagement fits
into the Mission of NCATS
CHRISTOPHER P. AUSTIN, M.D.
DIRECTOR, NCATS
SCIENCE OF COMMUNITY E...
The Best of Times, the Worst of Times
• Poor transition of basic or
clinical observations into
interventions that tangibly...
NCATS Mission
To catalyze the generation of innovative methods and
technologies that will enhance the development,
testing...
NCATS Mission: an informal but
important modification
To catalyze the generation of innovative methods
and technologies th...
NCATS “3D’s”
evelop
emonstrate
isseminate
NCATS History: A Synthesis
ORDR
(OD)
CTSAs
(NCRR)
NCTT
(NHGRI)
CAN
NIH
Institutes
& Centers
NCATS
Catalyzing Collaborations Within NIH
NEI
NCI NHLBI NIAID
NIDCR
NIDDK
NIAMS
NIDA
CIT
NIEHS
NIMH
NINDS
NCATS
NCCAM
NIMHD
NID...
Catalyzing Collaborations Outside NIH
• Complements and catalyzes (i.e.,
does not duplicate or compete with)
the work of o...
Translation is a team sport
Requires top performers with a wide variety of
different expertise to work together to a commo...
Standard Model
Basic Laboratory
Research
Clinical
Research
Translational
Research
Population
Research
Improved
Public
Heal...
The Way It Should Work
Basic Laboratory
Research
Patient-oriented
Clinical Research
Population-based Clinical
Research
Cli...
Clinical and Translational Science Awards Program
Led by NCATS Division of Clinical Innovation
CTSAs:
• Support a national...
Clinical and Translational Science Awards
(CTSA) Program Sites
Evolving CTSA Vision
• National leadership in enhanced quality, safety and efficiency in
translational research
• Innovati...
IOM Report on the CTSA Program
Current Status
• NIH commissioned a study by the IOM in July
2012 to evaluate the CTSA prog...
IOM Report
Community Engagement
• NCATS and the CTSA program should ensure that
patients, family members, health care prov...
Catalyzing Collaboration within NCATS
Across the Translational Spectrum
• What is meant by “community”?
• We really mean “...
NCATS and Community Engagement
Across the Translational Spectrum
• Observation to POC intervention(T1)
 Identify most imp...
NCATS and Community Engagement
Some Current Activities Inside and Outside
of CTSAs
CTSAs
CE Accomplishments
• Principles of Community
Engagement, 2nd edition
 Primer developed by CDC
and updated by the CE...
New Partnership for Drug Repurposing:
The Learning Collaborative
The
Learning
Collaborative™
• Focus on rare and
neglected...
TRND-led Niemann-Pick Type C (NPC) Disease Project
The Power of Collaboration
• Rare genetic progressive neurodegenerative...
Office of Rare Diseases Research
(ORDR)
• Rare Diseases Clinical Research Network (RDCRN)
 17 consortia at 225 institutio...
ORDR
Coordinated Effort
Federal/National
Governments
Regional/Local
Regulatory
Agencies
Research Agencies
Philanthropic
Fo...
Rare Diseases Clinical Research Network
Goals
• Facilitate clinical research by
 Creation of Consortia focused on minimum...
Rare Diseases Clinical Research Network
Webpage
Global Rare Diseases Patient Registry
and Data Repository (GRDR)
Pilot Project Overview
• 12 GRDR patient registries + 12 ...
GRDR
Benefits
• Ability to organize patient populations for clinical
trials and studies
• Patients can learn from other th...
NCATS and Community Engagement
Next Steps
• Implementation of IOM report
 Assembling working group of NCATS Advisory Coun...
Learn More About NCATS
Website: www.ncats.nih.gov
Facebook: facebook.com/ncats.nih.gov
Twitter: twitter.com/ncats_nih_gov
...
How Community Engagement Fits Into The Mission Of The National Center for Advancing Translational Sciences (NCATS)
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How Community Engagement Fits Into The Mission Of The National Center for Advancing Translational Sciences (NCATS)

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Christopher Austin, MD, Director of the National Center for Advancing Translational Sciences (NCATS) shared his thoughts on how community engagement fits into the mission of NCATS at the recent CTSA Community Engagement Key Function Committee (KFC) conference. He proposed a revision of NCATS' mission: "To catalyze the generation of innovative methods and technologies that will enhance the development, testing and implementation of interventions that tangibly improve human health across a wide range of human diseases and conditions." Learn more about NCATS http://www.ncats.nih.gov/

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How Community Engagement Fits Into The Mission Of The National Center for Advancing Translational Sciences (NCATS)

  1. 1. How Community Engagement fits into the Mission of NCATS CHRISTOPHER P. AUSTIN, M.D. DIRECTOR, NCATS SCIENCE OF COMMUNITY ENGAGED RESEARCH: FUTURE DIRECTIONS AUGUST 22, 2013
  2. 2. The Best of Times, the Worst of Times • Poor transition of basic or clinical observations into interventions that tangibly improve human health • Drug/device/diagnostic development system in crisis • Clinical trials system in crisis • Poor adoption of demonstrably useful interventions Fundamental science unprecedentedly advanced, but: People unhealthier and funders of biomedical research enterprise (public and private) impatient
  3. 3. NCATS Mission To catalyze the generation of innovative methods and technologies that will enhance the development, testing and implementation of diagnostics and therapeutics across a wide range of human diseases and conditions.
  4. 4. NCATS Mission: an informal but important modification To catalyze the generation of innovative methods and technologies that will enhance the development, testing and implementation of interventions that tangibly improve human health across a wide range of human diseases and conditions.
  5. 5. NCATS “3D’s” evelop emonstrate isseminate
  6. 6. NCATS History: A Synthesis ORDR (OD) CTSAs (NCRR) NCTT (NHGRI) CAN NIH Institutes & Centers NCATS
  7. 7. Catalyzing Collaborations Within NIH NEI NCI NHLBI NIAID NIDCR NIDDK NIAMS NIDA CIT NIEHS NIMH NINDS NCATS NCCAM NIMHD NIDCD NIGMSNINR NIAAA NICHD NLM CC OD NIA NHGRI FIC NIBIB CSR
  8. 8. Catalyzing Collaborations Outside NIH • Complements and catalyzes (i.e., does not duplicate or compete with) the work of others • Revolutionizes the process of translation • Fundamentally collaborative • Focuses on what is common to diseases and translation • Supports and augments regulatory science and its application • Expands the precompetitive space NCATS Biotech FDA Academia Pharma Advocacy Groups Community Orgs Public
  9. 9. Translation is a team sport Requires top performers with a wide variety of different expertise to work together to a common goal
  10. 10. Standard Model Basic Laboratory Research Clinical Research Translational Research Population Research Improved Public Health
  11. 11. The Way It Should Work Basic Laboratory Research Patient-oriented Clinical Research Population-based Clinical Research Clinical Trials Improved Public Health
  12. 12. Clinical and Translational Science Awards Program Led by NCATS Division of Clinical Innovation CTSAs: • Support a national consortium of medical research institutions • Work together to improve the way clinical and translational research is conducted nationwide • Accelerate the research translation process • Provide robust training for clinical and translation researchers
  13. 13. Clinical and Translational Science Awards (CTSA) Program Sites
  14. 14. Evolving CTSA Vision • National leadership in enhanced quality, safety and efficiency in translational research • Innovation in translational research methods, resources and services that catalyze the spectrum of translational research • Facilitate training and career development of robust translational workforce for interdisciplinary team research • Encourage institutions to build on their institutional strengths • Increased emphasis on transparency and fiscal oversight • Flexible academic, community and industry collaboration and partnership models built on shared commitment to translation • Engage communities in every phase of translational science
  15. 15. IOM Report on the CTSA Program Current Status • NIH commissioned a study by the IOM in July 2012 to evaluate the CTSA program • IOM CTSA Report released June 25, 2013 • The report includes 7 recommendations to build on the successes of the CTSA program and realize its full potential 1. Strengthen leadership of the CTSA program by NCATS 2. Reconfigure and streamline CTSA consortium 3. Build on the strengths of the individual CTSAs across the spectrum of research 4. Formalize and standardize clear, consistent, and novel metrics 5. Advance innovative education and training models with a focus on team science, leadership, and entrepreneurship 6. Ensure community engagement in all phases of research 7. Strengthen translational research relevant to child health
  16. 16. IOM Report Community Engagement • NCATS and the CTSA program should ensure that patients, family members, health care providers, clinical researchers, and other community stakeholders are involved across the continuum. • NCATS and the CTSA program should… 1. Define community engagement broadly 2. Ensure active and substantive community stakeholder participation in priority setting and decision making across all phases 3. Define and clearly communicate goals and expectations and ensure the broad dissemination of best practices 4. Explore opportunities and incentives to engage a more diverse community
  17. 17. Catalyzing Collaboration within NCATS Across the Translational Spectrum • What is meant by “community”? • We really mean “communities”  Patients, families, disease advocacy groups, non-profits, health care providers, clinical researchers, PBRNs, geographic groupings, cultural groups, faith-based organizations, local health departments, “the public” • Consistent involvement is critical for meaningful prioritization, focus, and outcomes • Particular focus on “innovative methods and technologies” to address critical research questions and advance translation T1-T4
  18. 18. NCATS and Community Engagement Across the Translational Spectrum • Observation to POC intervention(T1)  Identify most important research questions  Recruit best researchers  Build partnerships  Complementary funding for research studies  Bridge gap between fundamental science researchers and patients • Clinical and translational research (T2-T3)  Help develop relevant and practicable research protocols  Foster community participation and recruiting research participants for clinical trials  Increase collaboration and communication within the CTSA network and between key stakeholders (e.g., academia, public/private entities, and communities) • Community health and population research (T4)  Adoption of demonstrably useful interventions (i.e., dissemination)  Adherence  Interface with research partners including PCORI, Collaboratory, AHRQ, etc.
  19. 19. NCATS and Community Engagement Some Current Activities Inside and Outside of CTSAs
  20. 20. CTSAs CE Accomplishments • Principles of Community Engagement, 2nd edition  Primer developed by CDC and updated by the CE KFC taskforce • Community Engagement Consultative Service (CECS)  Helps individual CTSAs successfully engage with internal and external groups • Has been a driving force in the CTSA program
  21. 21. New Partnership for Drug Repurposing: The Learning Collaborative The Learning Collaborative™ • Focus on rare and neglected diseases • Industrial scale HTS, cheminformatics, medicinal chemistry, drug development capabilities • Pharma experience • Bench-to-bedside translation in drug repurposing • National leadership in medicinal and pharmaceutical chemistry • Pharma experience • ~400 active research projects • Worldwide network of blood cancer experts • Track record of commercial partnerships • Pharma experience
  22. 22. TRND-led Niemann-Pick Type C (NPC) Disease Project The Power of Collaboration • Rare genetic progressive neurodegenerative disease, death by teens  No FDA approved treatment • Project initiated 2007 via contact by disease advocacy groups  Goal: repurpose an existing drug for NPC treatment within current patients’ lifetimes • Drug identified in screen of NCATS drug collection  Currently in clinical testing • Key to success: Collaboration  10 different disciplines  Team: NCATS, 3 other NIH ICs, 4 universities, 2 companies, multiple patient groups
  23. 23. Office of Rare Diseases Research (ORDR) • Rare Diseases Clinical Research Network (RDCRN)  17 consortia at 225 institutions worldwide  Studying >200 diseases with 83 active protocols, and  More than 85 patient advocacy groups participating • Genetic and Rare Disease Information Center (GARD) • Scientific Conferences Program  Identify Scientific Opportunities and Establish Research Agendas (1200 Conferences) • Global Rare Disease Registry (GRDR) Data Repository  15 GRDR patient registries + 19 existing registries  Ability to conduct pan-disease analysis and recruitment
  24. 24. ORDR Coordinated Effort Federal/National Governments Regional/Local Regulatory Agencies Research Agencies Philanthropic Foundations Healthcare Services Reimbursements Healthcare Providers Medical Specialists Academic Research Industry Patient Advocacy Groups
  25. 25. Rare Diseases Clinical Research Network Goals • Facilitate clinical research by  Creation of Consortia focused on minimum three related rare diseases  Making meaningful large-scale clinical studies possible  Longitudinal cohorts, pilot projects, and randomized trials  Establishing uniform protocols for data collection • Direct community engagement of patients and their advocates as research partners • Enhance training of new investigators
  26. 26. Rare Diseases Clinical Research Network Webpage
  27. 27. Global Rare Diseases Patient Registry and Data Repository (GRDR) Pilot Project Overview • 12 GRDR patient registries + 12 existing registries • Ability to conduct pan-disease analysis and recruitment • Share de-identified patient data • Develop and use rare disease Common Data Elements (CDE) • Explore integration of Electronic Health Records (EHR) into GRDR • Develop an accessible web-based registry template • Establish a public/private partnership model of sustainability • Evaluate the data mapping, data export/import processes, and data mining capabilities
  28. 28. GRDR Benefits • Ability to organize patient populations for clinical trials and studies • Patients can learn from other through survey results • Raise visibility to patients and researchers • Complete questionnaires in local language • Ability to share drug development and clinical trial information with patients based on specific profile • Researchers learn directly from patients and families • Researchers able to recruit for clinical studies & trials pan-disorder
  29. 29. NCATS and Community Engagement Next Steps • Implementation of IOM report  Assembling working group of NCATS Advisory Council that will include diverse stakeholders • We know the WHY of CE innovation • We know the WHAT of CE innovation • The next step: The HOW of CE innovation  How to meaningfully identify and involve the right communities at the right stages?  How to change the culture of research to incorporate this?  How to measure the outcome (not just process) metrics to gauge success (or lack thereof) of our CE interventions and innovations? • We can do this, TOGETHER!
  30. 30. Learn More About NCATS Website: www.ncats.nih.gov Facebook: facebook.com/ncats.nih.gov Twitter: twitter.com/ncats_nih_gov YouTube: youtube.com/user/ncatsmedia E-Newsletter: ncats.nih.gov/news-and- events/e-news/e-news.html Email us! info@ncats.nih.gov

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