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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