Transcript Clinical and Translational Science Award (CTSA)

Clinical and Translational
Science Award (CTSA)
John F. Ennever
Medical Director, CTO
Director, RKSR
CTSA
• Part of the NIH “Roadmap”
• Re-engineering the Clinical Research
Enterprise
• An Institutional “Home” for Clinical and
Translational Sciences
The purpose of this initiative is to assist institutions to forge
a uniquely transformative, novel, and integrative
academic home for Clinical and Translational Science
that has the consolidated resources to:
1) captivate, advance, and nurture a cadre of well-trained
multi- and inter-disciplinary investigators and research
teams;
2) create an incubator for innovative research tools and
information technologies; and
3) synergize multi-disciplinary and inter-disciplinary clinical
and translational research and researchers to catalyze
the application of new knowledge and techniques to
clinical practice at the front lines of patient care.
CTSA the numbers
• Current funding for GCRC, and certain
other training grants
• Plus and additional $6 million/yr
• 5 year funding
• (caveats)
CTSA
• 12 Awards made 2006
Columbia
Duke
Mayo
Oregon
Rockefeller
UC Davis
UC San Francisco
Pennsylvania
Pittsburgh
Rochester
Texas, Houston
Yale
• Eventually 60 awards
• Ultimately replace ~80 GCRCs
CTSA
Fundamental difference from GCRC
Irving Center for Clinical Research
Irving Institute for Clinical and Translational
Research (IICTR)
No longer geographically-based
Degree Granting
Additional components
CTSA
Components
Research design, statistics, regulatory
affairs
Biomedical informatics
Career development program
In-patient, out-patient, and community
subject accrual sites
Core Labs
Pilot project program
IICTR Components
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DNMR
PCSR
BMIR
DBR
RKSER
CRC
CER
TTR
TRANSFORM
TER
(there will be a test at the end)
Development of Novel C/T
Methodologies Resource (DNMR)
This is the home for a group of junior
investigators, IICTR fellows, who are
supported by the IICTR and are expected
to be leaders in translational research on
campus. They are supported by a group
of more senior investigators who serve as
mentors
Pilot and Collaborative Studies
Resource (PCSR)
This Resource will provide funds for Clinical and
Translational (C/T) research at CUMC, including:
Pilot Awards (50k) to junior investigators to
develop pilot data
Irving Prizes (150k) for C/T Research and for C/T
Methodology
The latter two awards would go to multi- or
interdisciplinary groups of more senior
investigators joining together for new research
efforts.
Biomedical Informatics Resource
(BMIR)
This resource will develop and extend various informatics services to
support collaboration and data sharing – a common portal
Study workflow processes and identify inefficiencies and gaps
Introduce informatics interventions
Clinical – administrative
Clinical Trials Management System (Velos)
Collaborative technologies (Wiki)
Evaluate interventions
Frequency of use
End-user acceptance
Evaluate barriers
Design and Biostatistics Resource
(DBR)
This resource will:
Provide long-term, collaborative input, into the design,
conduct, and analysis of large epidemiologic studies and
clinical trials.
Offer short-term consulting support to smaller studies and
pilot projects for study design, data analysis, and analytic
interpretation.
Participate in the production of research manuscripts,
abstracts, and presentations with colleagues in the
CUMC community.
Assist colleagues from multiple disciplines in their pursuit of
independent research funding by serving as coinvestigators on multidisciplinary teams assembled for
novel research proposals.
Regulatory Knowledge and Support
and Ethics Resource (RKSER)
This resource is developing an educational
program that integrates ethical and
regulatory issues and serves the diverse
needs of the research community
Provide consultative services for both
regulatory (e.g., IRB, HIPAA, IND, IDE)
and ethical issues.
Practical training on Rascal
Patient & Clinical Interaction
Resource (PCIR – dba CRC)
This resource includes the inpatient and
outpatient component of the old GCRC
In addition, resources (i.e., research nursing
support) will be made available to other
clinical sites (e.g., ICUs, ERs)
Working to streamline the application
process – to integrate within Rascal for
parallel, not serial reviews.
Community Engagement Resource
(CER)
A requirement of the CTSA grant application
was a proposal to engage the community.
This resource is charged with enhancing the
participation of members of our community
in research and in engaging local
providers in research
Will include an off site location to see
research subjects
Translational Technologies and
Resources (TTR)
This is the old GCRC core lab with much, much
more.
Includes resources in:
Biomarkers
Clinical Genetics
Imaging (PET, fMRI)
Organic Synthesis
Botanicals, phytochemistry
Separate application process – not full GCTC
application.
Research Education, Training &
Career Development Resource
This was initially RETCDR but became
TRANSFORM
This is both a physical place (the Center for
Clinically Oriented Research Education –
CCORE) and an educational program.
MPOR
Ph.D.
Mentored scholars (K12 program)
Tracking & Evaluation Resource
(TER)
This is a resource that has been set up to
assure that we are making measurable
improvements in how clinical and
translational research is done at CUMC.
Where to get information
The temporary web address is:
www://gcrcweb.cpmc.columbia.edu/ctsa
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