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Introduction to the Institute of Translational Health Sciences
Kim Folger Bruce, PhDDirector of Research Partnerships
July 17, 2009
Learning Objectives
Learn about the ITHS cores and available services that support clinical and translational research teams
Learn how to navigate the new ITHS website Learn how to become a member
ITHS Overview The ITHS is part of a national
consortium, the Clinical and Translational Science Awards (CTSA), and is funded from the National Center for Research Resources, part of the National Institutes of Health. www.ctsaweb.org
The Institute is a partnership between the University of Washington, Seattle Children’s, the Fred Hutchinson Cancer Research Center and other local/regional institutions dedicated to improving human health.
Helps researchers obtain the education, resources and collaborations necessary to translate discoveries into practice.
ITHS MissionThe ITHS mission is to create, enable, and sustain innovative translational research and collaborations across disciplines and professions which will accelerate the development of concepts and tangible products that will improve human health.
Our common purpose is to: Foster innovative research and research partnerships Create and sustain research resources Ensure a translational research pipeline through robust
education and career development programs
Definition of Translational Research
Translational research involves moving knowledge and discovery gained from the basic sciences to its application in clinical and community settings. This concept is often summarized by the phrases "bench-to-bedside" and "bedside-to-community" research.
Phases of TranslationTranslational research has been described in
phases of translation, or "T-phases." The ITHS has adopted a model of 5 phases (T0-T4).
T0 is characterized by the identification of opportunities and approaches to health problems.
T1 seeks to move basic discovery into a candidate health application.
T2 assesses the value of application for health practice leading to the development of evidence-based guidelines.
T3 attempts to move evidence-based guidelines into health practice, through delivery, dissemination, and diffusion research.
T4 seeks to evaluate the “real world” health outcomes of population health practice.
adapted from Khoury MJ. et al. The continuum of translation research in genomic medicine: how can we accelerate the appropriate integration of human genomic discoveries into health care and disease prevention? Genet Med 2007:9(10):665-674.
Innovative Research and Research Partnerships
Pre-clinical Research Development Network
Biomedical Informatics
Community Outreach and Research
Translation Core
ResearchResources
Clinical Research Center Network
Translational Technologies and Resources Core
Center for Biomedical Statistics
Regulatory Support and Bioethics Core
ITHS Core and Program StructureAdministration: Portal and Program Incubator
Strategic Development and Evaluation
Education and Career Development
Short Courses
TL1
Tuition Support
KL2
Overarching Mentoring Programs
Funding Opportunities
ITHS Portal Service
The Portal evaluates project goals and provides information about:
ITHS and institutional resources and services
Pilot and other funding opportunities
Educational programs/mentoring
Collaborations ( through membership database)
General questions about translational and clinical research
Pre-Clinical Research Development Network
1. Drug and Device Development Advisory Committee
2. ITHS/Coulter MBA summer fellowships
3. Ignition Awards4. Academic Drug
Development Symposium
Highlights to date:• 2 types of Ignition Awards
• Primate center (3)• Pharmacy (3)
• Sponsored 7 MBA students• Supported 3 IND submissions• Supported 2 SBIR grant
proposal submissions
Regulatory and Bioethics Support1. Research bioethics consultation2. Research bioethics collaboration and
mentorship 3. Regulatory consultation visit program4. Regulatory audit program
In place and available5. Medical Monitoring and SAE reporting
In pilot phase but available 6. DSMB program
In development
Highlights to date:• Cross-institutional
investigator clinical research training program• 8 junior investigators thru
educational monitoring program• Completed the first year: ITHS
Clinical Research Educational Series• Established a research
coordinator core
Study and Data Management1. Study data management tools2. Computing and IT support for clinical
and translational research3. Accessing electronic medical record data4. Evaluation support5. Biomedical statistics 6. Research coordinator pool
Highlights to date:• Launched the Center for
Biomedical Statistics • Electronic tools for clinical
trials management• Amalga collaboration with
Microsoft• Toyota Lean: reduced
nurse overtime by 50% (CRC), decreased wait time for appointments
Research Lab Services1. Lab instrumentation and techniques 2. Scientific instrumentation data
access 3. Bionutrition and body composition
consultation
Working in the Community1. Conducting practice-based research 2. Building partnerships with American
Indian/Alaska Native communities 3. NWABR: Request a speaker or get
speaker training
Highlights to date:• Created an institutional
technology inventory with searchable web tool• Established WWAMI Practice
Based Research Network• Piloted Data-Quest at key
WWAMI practice sites• Speaker training workshop
Small Pilot Project GrantsTwice yearly10K, applications due Sept 28, 2009
Technology/Resource Access GrantsThree times a year10K, applications due November 1, 2009
Ignition/Primate Center AwardAnnually100K, applications due February, 2010
ITHS Ignition/Pharmacy AwardAnnually20-40K, applications due in October, 2009
Highlights to date:• In first 16 months, ITHS
awarded 60 grants for over $1M to investigators
representing 9 institutions• Funding level 20-35%
depending on mechanism
• Training program for grant review
• Mentor program for those grants that miss funding
Predoctoral Multidisciplinary Clinical Research TL1 Training - offered as both a summer and a 12-24 month certificate-degree program. Postdoctoral Clinical Research Career Development KL2 - multidisciplinary program, up to 5 years in length ITHS Tuition Support Fellowship - provides tuition support for MS or MPH degree in Epidemiology or Health Services from the School of Public Health and Community Medicine.
Degree and Certificate Programs
ITHS monthly Clinical Research Education Series - A seminar series for investigators and research staff that features 23 clinical and translational research topics to be presented over two year cycle.
ITHS monthly Career Development Series for Scholars - A seminar series for scholars that features topics such as grant-writing, writing for publication, presenting at scientific meetings, and more.
ITHS monthly Technology Resources Seminar Series - A seminar series highlighting local research resources Other ITHS Seminars, Training, and Short Courses - A broad array of training opportunities including the ITHS annual Boot Camp, Fundamentals of Clinical Trials, and more.Educational Clearinghouse - Clinical and translational research training opportunities outside of ITHS, including certificate and degree programs, courses, training (, Good Clinical Practice, Human subject protection, etc.), workshops, and clinics offered by partners and other institutions.
Seminars and Short Courses
Clinical and Translational Research Boot Camp
The ITHS Clinical and Translational Research Boot Camp Basic training in clinical and translational research methods Topics include: biostatistical concepts, clinical epidemiology and study design, ethical
issues in research on human subjects, grantsmanship, randomized clinical trials, and regulatory issues.
The targeted audience is primarily incoming fellows and new faculty, other interested parties are welcome.
Participants must be either an ITHS Member or Scholar to attend.
Dates: September 21 through 25, 2009
Time: 9:00-11:50, 1:00-3:50 Monday-Friday (thirty 50-minute sessions)
Location: University of Washington, Magnuson Health Sciences Building, Room T733
Online Registration: Pending
All lectures will be streamed live on-line and archived to be made available later via the web as a benefit to ITHS members.
For more information about the ITHS Clinical and Translational Research Boot Camp please send an email to [email protected] or call (206) 616-5163.
ITHS Membership To reach our goals of promoting translational
research requires collaboration between many groups: academia, industry, non-profit agencies, government, and the community. Any researcher or individual interested in translational research from any group is invited to become a member of the ITHS.
Currently have 754 members from the WWAMI region