Enhancing%20Clinical%20and%20Translational%20Research%20at%20UNMC - PowerPoint PPT Presentation

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Title: Enhancing%20Clinical%20and%20Translational%20Research%20at%20UNMC

Enhancing Clinical and Translational Research at
  • Lynell Klassen, Jennifer Larsen, Elizabeth

What is Clinical Research?
What Clinical Research is NOT
  • Research done by an MD
  • Publication of clinical observations
  • Post-marketing observational trials

NIH definition of Clinical Research (PHS 398)
  • Patient-oriented research. Research conducted
    with human subjects (or of human origin -
    tissues, specimens and cognitive phenomena) for
    which an investigator (or colleague) directly
    interacts with human subjects (a) mechanisms of
    human disease, (b) therapeutic interventions, (c)
    clinical trials, or (d) development of new
  • Epidemiologic and behavioral studies.
  • Outcomes and health services research.

What is Translational Research?
  • There are two types
  • Type 1 Preclinical bench to bedside
  • Pre-clinical modeling
  • Clinically based hypothesis
  • Type 2 Post-clinical trial to community (best

UNMC Clinical Research Today
  • State-of-the art clinical facilities and
    specialized regional centers for a variety of
    diseases with a Childrens Hospital for pediatric
    specialty care
  • CRC to support investigator-initiated research
    with space, research nurses, lab, research
  • Clinical Trials Office for Pharma-driven trials

Current Clinical Research enterprise
  • Additional research spaces Cruzan Center for
    Dental Research in Lincoln, Clinical research
    space at OVAMC but not Childrens Hospital
  • Electronic medical record and nationally known
    medical informatics expertise
  • Biostatistics/trial design previously in Prev Soc
    Med moved to the COPH additional qualitative
    analysis expertise at UNL
  • Nationally known expertise in human studies
    regulation and bioethics

Current Clinical Research enterprise
  • Growing bioinformatics and biotechnology
  • GMP facility for cellular therapies under
  • Expertise in distance learning, web-based data
    entry, and long distance research collaborations
  • Strong community partnerships with rural
    communities, minority groups in and outside NE
  • Clinical research training in evolution
    Stats-Epi track in MPH, interdisciplinary
    Clinical Research track within MSIA, and Health
    Services PhD

Building clinical and translational research
  • Elizabeth Seaquist MD
  • Professor of Medicine
  • Program Director, General Clinical Research
  • Co-PI, CTSA
  • University of Minnesota

A Transforming Approach NIH Institutional
Clinical and Translational Science Awards (CTSA)
  • Implementing biomedical discoveries made in the
    last 10 years demands an evolution of clinical
  • New prevention strategies and treatments must be
    developed, tested, and brought into medical
    practice more rapidly
  • CTSA awards will lower barriers between
    disciplines, and encourage creative, innovative
    approaches to solve complex medical problems
  • These clinical and translational science awards
    will catalyze change -- breaking silos, breaking
    barriers, and breaking conventions

How is this transformation achieved?
  • Through the NIH Roadmap for Medical Research,
    create an integrated environment for the clinical
    and translational researcher that can provide
  • an academic home for clinical research (a Center,
    Department, or Institute C/D/I)
  • support for protocol preparation, regulatory
    compliance and data management
  • support for participant recruitment, human
    subject safety monitoring
  • education leading to advanced degrees in clinical
  • specialized cores and services for translational

Where are we starting from?
Disease X Center
Training Programs
Disease Y Center
NIH CTSA Awards A Home for Clinical and
Translational Science
Clinical Research Ethics
Trial Design
Advanced Degree-Granting Programs
Biomedical Informatics
Participant Community Involvement
Clinical Resources
Regulatory Support
NIH Clinical Translational Science Awards
  • By 2010 (2012?), all GCRCs and Roadmap training
    programs (T32/K30/K12) will disappear or be
    incorporated into a CTSA
  • Approximately 60 CTSAs will be funded in total
  • CTSA award will lower barriers between
    disciplines, and encourage creative, innovative
    approaches to solve complex medical problems
  • CTSA award will provide new opportunities for
    institutions to be truly innovative in proposals
    to transform their programs and resources to
    foster clinical and translational science.
  • Long term goal is to speed discoveries to
    improved patient care

CTSA Specific Objectives (RFA 3/07)
  • Provide opportunities and resources for original
    research on novel methods and approaches to
    translational and clinical science
  • Provide translational technologies and knowledge
    base for spectrum of clinical and translational
    science , including all types and sizes of
    studies and disciplines
  • Integrate translational and clinical science by
    fostering collaboration between departments and
    schools within institution and between
    institutions and industry
  • Provide a point a contact for partnerships with
    industry, foundations, and community physicians
  • Provide research education, training and career
    development leading to a MS or PhD for the next
    generation of clinical and translational
  • Conduct self-evaluation activities and
    participate in a national evaluation of the CTSA

CTSA components
  1. Development of Novel Clinical and Translational
  2. Pilot and Collaborative Translational and
    Clinical Studies
  3. Biomedical Informatics
  4. Design, Biostatistics, Clinical Research Ethics
  5. Regulatory Knowledge and Support
  6. Participant and Clinical Interactions
  7. Community Engagement
  8. Translational Technologies and Resources
  9. Research Education, Training, and Career

Organization CTSA resources
Budgetary constraints I.
  • Only 1 application may be submitted from each
    degree granting institution
  • Total cost Combined budgets of existing
    GCRC/T32/K30/K12 awards 6 million
  • Institutions like UNMC without GCRC/T32/K30/K12
    can request up to 6 million
  • IDC institutional rate U54 portion, 8 of
    K12/T32 portion

Budgetary constraints II.
  • If more than 4 million total costs above
    existing GCRC/T32/K30/K12 is requested,
    applicants must
  • discuss how they will develop and support
    translational research and career development in
  • discuss the opportunities that will carry their
    clinical and translational science endeavors into
    community settings
  • describe the institutional commitments that match
    the increased scale of the program

Round one of applications
  • 34 Applications
  • Awards given to 12 centers
  • Columbia University Health Sciences
  • Duke University
  • Mayo Clinic College of Medicine
  • Oregon Health Science University
  • Rockefeller University
  • University of California, Davis
  • University of California, San Francisco
  • University of Pennsylvania
  • University of Pittsburgh
  • University of Rochester
  • University of Texas Health Science Center at
  • Yale University

Round 2 of applications
  • 27 are believed to have applied
  • Up to 8 will be awarded (38
    million available)
  • Review is in May
  • Start date is September 2007

Elements of successful applications
  • Strong institutional support
  • ( equal to grant request new space, has
    gone gt100 million over grant period)
  • Clear vision
  • Well integrated
  • Multidisciplinary
  • Innovative

How has the University of Minnesota responded to
the RFA?
  • Fall 2003 AHC Clinical Research Task Force
  • 11/04 Task Force Report released
  • 9/05 AHC Office of Clinical Research opened with
    Jas Ahluwalia as Executive Director
  • First CTSA RFA released 10/05
  • 10/05-3/06 - Grant planned, written, submitted
  • Application incorporated 36 yr old GCRC with its
    specialized cores and research support services
    newly funded Roadmap K12 institutional support
    for industry protocols
  • 66 million in total costs requested
  • Institutional commitment 30,000 sq ft in
    renovated bldg for CTSA, renovation of existing
    10,000 sq ft GCRC, 50 million over 10 yrs

How has the University of Minnesota responded to
the RFA?
  • Summer 06 Application not funded (249)
  • Strengths
  • Institutional commitment
  • Training section
  • Bioethics
  • Creation of physical home
  • Weaknesses
  • organization complexity
  • lack of details about implementation/integration
  • all MDs in leadership
  • unrealistic about potential problems
  • poor bioinformatics

How has the University of Minnesota responded to
the RFA?
  • October 06 Second RFA released
  • 10/06-12/06 Draft prepared and rejected -
    decided to defer to 10/07
  • 3/07 Third RFA released
  • Plan to re-submit October 2007

CTSA Review
  • Each application is assigned 8 reviewers and
    each reviewer is assigned one of following areas
  • Significance, Approach, Innovation, Environment,
    and Implementation
  • Staffing, Governance, Institutional Commitment,
    Evaluation Plans
  • Biomedical Informatics
  • Clinical Research Design and Biostatistics,Communi
    ty Engagement, Regulatory Knowledge and Support
  • Translational Technologies and Resources, Pilot
  • Training
  • 7,8. Overall (Integration, Impact, Anticipates

ICTR Governance
Frank Cerra, MD Senior Vice President Academic
Health Center
External Advisory Committee
Deborah E. Powell, MD Assistant VP Clinical
Jasjit S. Ahluwalia, MD, MPH, MS Principal
Internal Advisory Committee Deans, Mark Paller,
Eileen Harwood, PhD (SPH) Director, Evaluation
Community Engagement Mary Story, PhD (SPH) Co-PI
Education, Training Career Development Russell
Luepker, MD, MPH (SPH) Co-PI
Clinical Elizabeth Seaquist, MD (Med) Co-PI
Translational Jeff Miller, MD (Med) Tim Tracy,
PhD (Pharm) Bruce Blazar,MD (Med)
CTSA Challenges
  • Balance - Finding balance between describing what
    you do well and what needs to change is difficult
    (i.e., Why should NIH give us grant if we already
    do everything well? vs. If we describe everything
    that needs changing, it seems negative.)
  • Perspective All investigators believe what they
    do is most innovative and deserves highest
    priority. CTSA includes implicit judgment (e.g.,
    In what order does one list functions? How does
    the budget get allocated?)
  • Budget - 6 million additional per year is not
    enough (especially since only 4 million is
    direct costs) to do all that is asked for in the
  • Change It is difficult to acknowledge that what
    we have been doing is not optimal (Clinical
    Research TF helped) and figuring out how to
    change it is even more so. Most people will agree
    to change in the abstract the devil is in

CTSA Lessons Learned
  • Be flexible good ideas can come after initial
    decisions have been made
  • Listen to the skeptics they will make your
    grant stronger
  • Provide a structure for sections early on and
    dont let authors argue that the structure
    doesnt fit for my section
  • Make a timeline that allows time for internal and
    external review and stick to it
  • Its never too early to begin gathering
  • The best sections were drafted early and went
    through many reviews
  • The best sections incorporated ideas from many
  • Identify reviewers that are not intimately
    involved with the grant to provide feedback on
    ideas and to proof read

State of clinical and translational research 2013
  • Clinical and translational research will be
    supported by a robust network of centers
    supported by CTSA program
  • Funded centers will collaborate with each other
    and with unfunded institutions in their region to
    speed discovery into practice
  • Clinical and translational research will become
    the preferred career path for talented health

What dont we have?
  • Current clinical research space
    inadequate-temporary, small, and at Childrens--
  • Clinical research training programs still being
    developed-clinical research mentor pool still
  • Clinical research processes are not
    transparent-no one place, no one person knows
  • Processes not efficient time to contract and
    time to final IRB approval (benchmarklt4-6 weeks),
    biotechnology licensing, separate IRB approval
    and credentialing of research personnel at
    Childrens time consuming

What dont we have?
  • New collaborations slowed by many factors
    faculty , type, or difficult to find
  • No facility to manufacture drugs
  • Mixed messages on value of interdisciplinary
    clinical research no space assigned for funded
    clinical research, only PI given credit for
    research performed by investigator teams
  • Accountability less than clear who is in
    charge of clinical research?

What dont we have?
  • Serving the larger community
  • Health data in our hospital, county, or state not
    easily accessible to evaluate or study health
    concerns or outcomes
  • CTSA RFA need to show how we can move basic
    research all the way to community implementation
    and take community concerns back to the
    laboratory- What will it take to do this?

Securing an NIH CTSA
  • A physical and administrative home for Clinical
    research across UNMC
  • Mentored interdisciplinary clinical research
  • New ways of organizing our research enterprise to
    speed up translation from bench ltgt bedside ltgt
    community better access to available data, new
    and innovative ways to gather new data, teams to
    address health issues, minority and rural
    community engagement
  • This work can only be accomplished by a team of
    individuals who have been given institutional
    authority and committed to UNMCs success

A lot is at stake
  • The final 60 CTSAs will be the driving force
    behind NIH-funded clinical research for the next
    40 years
  • The CTSA is now the model of how clinical
    research should be done gt UNMC needs to
    transform its research enterprise just to keep
    in the game
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