how community engagement fits into the mission of the national center for advancing translational...
DESCRIPTION
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/TRANSCRIPT
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
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
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.
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.
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
NIDCD
NIGMS NINR
NIAAA
NICHD
NLM
CC
OD
NIA
NHGRI
FIC
NIBIB
CSR
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
Translation is a team sport
Requires top performers with a wide variety of different expertise to work together to a common goal
Standard Model
Basic Laboratory
Research
Clinical
Research
Translational
Research
Population
Research
Improved
Public
Health
The Way It Should Work
Basic Laboratory
Research
Patient-oriented
Clinical Research
Population-based Clinical
Research
Clinical Trials
Improved
Public Health
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
Clinical and Translational Science Awards (CTSA) Program Sites
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
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
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
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
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.
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 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
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
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
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
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
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
Rare Diseases Clinical Research Network Webpage
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
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
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!
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! [email protected]