NIH Roadmap - University of Kansas Medical Center by liuqingyan

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									What is the NIH Roadmap
         Anyway?
      Lauren S. Aaronson, PhD, RN, FAAN
        Professor, School of Nursing and
Department of Health Policy and Management, SOM
     Deputy Director, Heartland Institute for
       Clinical and Translational Research
National Institutes of Health
    (NIH; www.nih.gov)
   Within the Department of Health and
    Human Services
   Composed of 27 separate Institutes
    and Centers
   The major US funder of health-related
    research and research training (both
    extra-mural and intra-mural)
   Budget: over $31 Billion for FY 2010
                NIH Institutes
            (with Dates established)
   National Cancer Institute (NCI) 1937
   National Heart, Lung, and Blood Institute (NHLBI) 1948
   National Institute of Allergy and Infectious Diseases
    (NIAIDS) 1948
   National Institute of Dental and Craniofacial Research
    (NIDCR) 1948
   National Institute of Diabetes and Digestive and Kidney
    Diseases (NIDDK) 1948
   National Institute of Mental Health (NIMH) 1949
   National Institute of Neurological Disorders and Stroke
    (NINDS) 1950
   National Library of Medicine (NLM) 1956
   National Institute of Child Health and Human Development
    (NICHD) 1962
   National Institute of General Medical Sciences (NIGMS)
    1962
               NIH Institutes
           (with Dates Established)
 National Eye Institute (NEI) 1968
 National Institute of Environmental Health Sciences
  (NIEHS) 1969
 National Institute on Alcohol Abuse and Alcoholism
  (NIAAA) 1970
 National Institute on Drug Abuse (NIDA) 1973
 National Institute on Aging (NIA) 1974
 National Institute of Nursing Research (NINR) 1986
 National Institute of Arthritis & Musculoskeletal & Skin
  Diseases (NIAMS) 1986
 National Institute of Deafness and Other
  Communication Disorders (NIDCD) 1988
 National Human Genome Research Institute (NHGRI)
  1989
 National Institute of Biomedical Imaging and
  Bioengineering (NIBIB) 2000
             NIH Centers
         (with Dates established)
   Center for Scientific Review (CSR) 1946
   National Clinical Center (CC) 1953
   National Center for Research Resources
    (NCRR) 1962
   Center for Information Technology (CIT) 1964
   John E. Fogarty International Center (FIC)
    1968
   National Center on Minority Health and Health
    Disparities (NCMHD) 1993
   National Center for Complementary and
    Alternative Medicine (NCCAM) 1999
Types of Research Grants
              (“R” for Research)
   NIH Research Project Grant Program (R01)
   NIH Small Grant Program (R03)
   NIH Support for Conferences and Scientific
    Meetings (R13 and U13)
   NIH Academic Research Enhancement Award
    (AREA) Grants - (R15)
   NIH Exploratory/Developmental Research Grant
    Award (R21)
   NIH Dissertation Award (R36)
   NIH Clinical Trial Planning Grant Program (R34)
   NIH High Priority, Short-Term Project Award (R56)
          Ruth L. Kirschstein (NRSA)
National Research Service Awards
    (“T” for Training; “F” for Fellowship)
   Institutional Research Training Grants (T32)
   Short-Term Institutional Research Training
    Grants (T35)
   Individual Predoctoral Awards For M.D./Ph.D.
    Fellowships (F30)
   Individual Predoctoral Fellowship Minority
    Students (F31)
   Individual Predoctoral Fellowship Students
    w/Disabilities (F31)
   Individual Predoctoral Fellowship (F31)
   Individual Postdoctoral Fellowships (F32)
   Senior Fellowships (F33)
Career Development Awards
                  (“K” for Career)
   Mentored Research Scientist Development Award (K01)
   Independent Scientist Award (K02)
   Senior Scientist Award (K05)
   Academic Career Award (K07)
   Mentored Clinical Scientist Research Career Development
    Award (K08)
   Mentored Clinical Scientist Development Program Award (K12)
   Career Enhancement Award for Stem Cell Research (K18)
   Career Transition Award (K22)
   Mentored Patient-Oriented Research Career Development
    Award (K23)
   Midcareer Investigator Award in Patient-Oriented Research
    (K24)
   Mentored Quantitative Research Development Award (K25)
   Midcareer Investigator Award in Mouse Pathobiology Research
    (K26)
   Clinical Research Curriculum Development (K30)
   NIH Pathway to Independence (PI) Award (K99/R00)
     Enhanced Support for New
          Investigators
   ―New Investigator‖ — If one has not
    previously competed successfully for a
    significant NIH research award.
    • Exceptions: R00, R03, R15, R21, R34,
      R36, R41, R43, R55, R56

   ―Early Stage Investigator‖ — If one is
    within 10 years of completing terminal
    research degree or medical residency.
PATHWAY TO INDEPENDENCE
    AWARD (K99/R00)



 • Five years of support consisting of two phases
 • Phase I provides 1-2 years of mentored support for
   advanced fellows
 • Total cost of $90,000 per award including 8% F&A
 • Phase II provides up to 3 years of independent
   research support contingent upon securing an
   independent research position and administrative
   review.
 • Total cost of $249,000 per award including full F&A
         Challenges for NIH

   Revolutionary and rapid changes in science
   Increasing breadth of mission and growth
   Complex organization with many units
    (27 institutes and centers, multiple program
    offices, e.g., ORWH, OAR, ORD, ...)
   Structured by Disease, Organ, Life stage,
    Disciplines ….
         Imperatives for NIH
   Accelerate pace of discoveries in life
    sciences
   Translate research more rapidly from
    laboratories to patients and back
   Explore novel approaches in orders of
    magnitude more effective than current
   Develop new strategies: NIH Roadmap
How was the NIH Roadmap
      developed?
 Extensive consultations with
 stakeholders, scientists, health care
 providers addressing:
 • What are today’s scientific challenges?
 • What are the roadblocks to progress?
 • What do we need to do to overcome
   roadblocks?
 • What cannot be accomplished by any single
   Institute – but is the responsibility of NIH
   as a whole?
Evolving Public Health
     Challenges
     Acute to Chronic Conditions


     Aging Population


     Health Disparities

     Emerging Diseases


     Biodefense
        Roadblocks


Bench     Bedside        Practice
          (aka Cinical
          Research)
What is the NIH Roadmap?
 A framework of priorities the NIH as
  a whole must address in order to
  optimize its entire research portfolio
 A vision for a more efficient,
  innovative and productive system
  of biomedical and behavioral
  research
 A set of initiatives that are central
  to extending the quality of healthy
  life for people in this country and
  around the world
   NIH Roadmap Goals
• Accelerate basic research
discoveries and speed translation of
those discoveries into clinical practice

• Explicitly address roadblocks that
slow the pace of medical research in
improving the health of the American
people
Three Roadmap Themes
       Emerged
             New Pathways
              to Discovery




                 NIH


Research Teams          Re-engineering the
 of the Future     Clinical Research Enterprise
Roadmap Implementation
       Groups
 New Pathways to Discovery
 ◦   Molecular Libraries and Imaging
 ◦   Building Blocks, Biological Pathways and Networks
 ◦   Structural Biology
 ◦   Bioinformatics and Computational Biology
 ◦   Nanomedicine
 Research Teams of the Future
 ◦ Interdisciplinary Research
 ◦ High-risk Research
 ◦ Public-Private Partnerships
 Re-engineering the Clinical Research
  Enterprise
New Pathways to Discovery
    Initiatives within this theme address
technologies and approaches necessary to
 meet contemporary research challenges.

   Grasping the emerging complexity of biology
   Understanding biological systems
   Accessing biological data, technologies, and
    other scientific resources
   Promoting Multi-and Interdisciplinary research
Research Teams of the Future
   Initiatives within this theme provide
 mechanisms for interdisciplinary research,
  high-risk strategies and public-private
                partnerships.
   Encouraging Multi- and Interdisciplinary teams
   Supporting larger, coordinated, resource
    sharing teams
   Preserving the investigator-initiated strategy
   Promoting investigators to take creative,
    unexplored avenues of research
Reengineering the Clinical
  Research Enterprise

Initiatives within this theme address new
  strategies to enhance infrastructure and
     capacity for clinical research and to
reenergize the clinical research workforce
 through creating better integrated clinical
 research networks, preparing the clinical
    research workforce, and developing
          technologies and policies.
Multi- and Interdisciplinary Research is
  Required to Solve the “Puzzle” of
 Complex Diseases and Conditions


  Genes
  Behavior
  Diet/Nutrition
  Infectious agents
  Environment
  Society
  ???
Multi- and Interdisciplinary Research

  A                           A
          Work on
                                  Multidisciplinary
      common problem
  B                           B


  A
           Interaction
                          C       Interdisciplinary
      forges new discipline
  B
      Challenges to Interdisciplinary
               Research
 The current system of academic
  advancement favors the independent
  investigator
 Most institutions house scientists in
  discrete departments
 Interdisciplinary research teams take
  time to assemble and require unique
  resources
 Interdisciplinary science requires
  interdisciplinary peer-review
 Project management and oversight is
  currently performed by discrete ICs
 Interdisciplinary research training is a
  pre-requisite to interdisciplinary
  research
       Transforming Research
          Training means:

• Linkages among biological, behavioral,
social, and physical sciences
• Collaboration between clinicians and
scientists
• Partnerships with
industry
Re-Engineering Clinical Research
  Clinical research has evolved haphazardly
   ◦ Started as cottage industry and select centers
   ◦ Now has more complex requirements: regulation,
     technology, speed, efficiency
   ◦ Greater links to basic science
  Need transformation to move into the 21st Century
   ◦ Individual apprenticeship  discipline of clinical research
   ◦ Uniform gauge  harmonize rules, build infrastructure and
     create networks
   ◦ Focus on mentoring  multi- & interdisciplinary teams
  Value and need access to well characterized
   cohorts of patients and biological samples
    National Impetus for Clinical
     and Translational Science
      Award (CTSA) Program
   Today’s public health problems cannot be solved by a
    single discipline
   Time from discovery in the lab to application in clinical
    practice way too long (~17 years)
   Paucity of clinical & translational investigators, difficulty
    recruiting and retaining, clinical service demands
   Unique and complex challenges of clinical & translational
    research (e.g., regulatory requirements)
   Relative value of clinical & translational research vis a vis
    basic research
   Limitations/barriers due to NIH funding mechanisms,
    review and program structures
  CTSA’s Transforming Goal

Provide the academic home and integrated
  resources needed to advance the new
  intellectual discipline of clinical and
  translational sciences, create and nurture a
  cadre of well-trained investigators, and
  advance the health of the nation by
  transforming patient observations and basic
  discovery research into clinical practice
                    NIH CTSA Program:
   A Home for Clinical and Translational Science

         Clinical
        Research                 Trial Design
                                                              NIH
         Ethics

                                          Advanced
Biomedical
                                          Degree-Granting
Informatics
                          CTSA            Programs
                          HOME
                                       Participant              Industry
   Clinical                           & Community
  Resources                           Involvement

          Biostatistics      Regulatory
                              Support
                                                               Other
                                                            Institutions
    NIH Definition of Clinical
           Research
(1) Patient-oriented research.
  Research conducted with human subjects (or on material of
   human origin such as tissues, specimens and cognitive
   phenomena) for which an investigator (or colleague) directly
   interacts with human subjects. Excluded from this definition are
   in vitro studies that utilize human tissues that cannot be linked
   to a living individual. Patient-oriented research includes: (a)
   mechanisms of human disease, (b) therapeutic interventions,
   (c) clinical trials, or (d) development of new technologies.

(2) Epidemiologic and behavioral studies.

(3) Outcomes research and health services research.
 Clinical and Translational
          Research
• Clinical Research: Covers all studies of
 diseases and trials of treatments that take place
 with human subjects
• T1 Translational Research:        Applying
 discoveries generated during research in the
 laboratory, and in preclinical studies, to the
 development of trials and studies in humans
• T2 Translational Research:    Research
 aimed at enhancing the adoption of best
 practices in the community
Bench to Bedside to Practice
        (and Back)
    CTSA Program
Components/Key Functions
   Research Education, Training and Career
    Development
   Development of Novel Methods and Translational
    Technologies
   Pilot and Collaborative Translational and Clinical
    Studies
   Biomedical Informatics
   Research Design, Epidemiology, Biostatistics
   Regulatory Knowledge and Support, and Clinical
    Research Ethics
   Participant and Clinical Interaction Resources
   Community Engagement and Research
   Evaluation
    CTSA Program Vision/Goals
               (www.ctsaweb.org)
Vision: Improve human health by transforming the
  research and training environment to enhance the
  efficiency and quality of clinical and translational
  research

   Goal 1: Build National Clinical and Translational
       Research Capability
   Goal 2: Provide Training and Improving the Career
       Development of Clinical and Translational Scientists
   Goal 3: Enhance Consortium-Wide Collaborations
   Goal 4: Improve the Health of our Communities and the
       Nation
   Goal 5: Advance T1 Translational Research
Current CTSA Consortium
  55 of 60 Funded to Date
       Why KU Needs a CTSA
   Resources needed for clinical & translational research
    cannot be efficiently or effectively provided at
    departmental or investigator level
   University-wide coordinated infrastructure for clinical &
    translational research akin to labs for basic science
   Clinical and translational research requires cross-
    disciplinary resources
   Access to national limited competition grants
   Access to CTSA consortium collaborations
   Support trans-university education & training of next
    generation of clinical & translational investigators
   Prestige factor (akin to NCI designation)
KUMC’s CTSA APPLICATION
     Heartland Institute for Clinical and
      Translational Research (HICTR)
   HICTR Director and PI: R. Barohn, MD
   HICTR Deputy Director and PI: L. Aaronson, PhD, RN
   Clinical and Translational Research Education Center
    (CTREC): E. Ellerbeck, MD
   Novel Methods/IAMI: S. Weir, PharmD, PhD
   Translational Technologies Resource Center (TTRC): W.
    Brooks, PhD
   Pilot and Collaborative Studies: G. Kopf, PhD
   Biomedical Informatics: R. Waitman, PhD
   Biostatistics: M. Mayo, PhD
   Regulatory Knowledge and Support: G. Kopf, PhD
   Ethics: J. Lantos, MD
   Community Partnership for Health: A. Griener, MD
   Participant & Clinical Interactions Resources: J. Burns, MD
   Evaluation: W. Boulden, PhD
HICTR ADVISORY STRUCTURE
    Affiliated Community Network Institutions
    AcademicInstitutions Network
              Community                     Health Delivery Systems Community
                                                     Network Institutions
                                            University of Kansas Hospital –
    University of Missouri—Kansas City       Kansas City, KS
                                            Wesley Medical Center—Wichita, KS
      • School of Medicine
                                            Via Christi Health System—Wichita,
      • School of Nursing
                                              KS
      • School of Dentistry                 Kansas City Veterans Administration
      • School of Pharmacy                    Medical Center—Kansas City, MO
      • College of Liberal Arts & Sciences  St. Luke’s Health System—Kansas
    Kansas City University of Medicine       City,( MO and KS campuses)
     and Biosciences                        Children’s Mercy Hospitals and
                                              Clinics-- Kansas City,( MO and KS
                                              campuses)
                                            Truman Medical Center—Kansas
                                              City, MO
                                            Swope Health Services—Kansas
                                              City, MO
                                            Center for Behavioral Medicine—
                                              Kansas City, MO
         Clinical Research:
Navigating the Roadway “Traffic Jam”
 • Clinical research
  impeded by multiple and
  variable requirements to
  address fundamentally
  the same oversight
  concerns

 • Variability among and
  within federal agencies,
  including NIH
     o   Creates uncertainty
         about how to comply
     o   Hampers efficiency and
         effectiveness
     Summary of Intent of the
          Roadmap
   Accelerate the pace of discoveries for
    preventing, detecting, and treating diseases
    and disability
   Accelerate the pace of translating research
    from bench to bedside to practice and back
   Foster scientific advances at the interface of
    traditional disciplines
   Promote the development interdisciplinary
    science and methods
   Acknowledge and incorporate the significance
    and relevance of behavioral and social
    sciences for a comprehensive understanding
    of disease prevention, etiology and treatment,
    and the promotion of health and well-being
The NIH Roadmap:
A Work in Progress
Questions??/Comments??




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