Connect • Learn • Get Help • The CTSI helps research teams work faster and better.
NCATS Transition • Leadership • Interim Director Tom Insel (Director of NIMH) • Chris Austin named as Director Sep 2012 • Divisions of Preclinical Innovation and Clinical Innovation had interim directors, Petra Kaufmann now Clinical Innovation Director • 12/23/2011: NCATS formed; NCRR disbanded • NCATS Purpose: advance translational sciences by • coordinating and developing resources that leverage basic research in support of translational science; and • developing partnerships and working cooperatively to foster synergy in ways that do not create duplication, redundancy, and competition with industry activities.
IOM Report – released 6/25/2013 • Suggested vision: • A “tightly integrated network that works collectively to enhance the transit of therapeutics, diagnostics, and preventive interventions along the development pipeline; disseminate innovative translational research methods and best practices; and provide leadership in informatics standards and policy development to promote shared resources.” • Recommendations • (roughly in order of prominence): • NCATS should take a more active leadership role as the principal party in cooperative agreements • Greatly streamline committee structure • The consortium should work more cohesively together and with external partners toward carefully chosen strategic goals • Establish a cross-consortium “Innovation Fund” • Tighten up the evaluation program • CTSAs should be allowed more freedom to capitalize on institutional strengths • CTSAs should concentrate efforts toward innovative education programs • CTSAs should continue to lead efforts in child health research
NCATS Response to the IOM Report • NCATS Advisory Council Working Group on the IOM Report: The CTSA Program May 2014 • Workforce Development-Goal: The translational science workforce has the skills and knowledge necessary to advance translation of discoveries. • Collaboration/Engagement-Goal: Stakeholders are engaged in collaborations to advance translation. • Integration-Goal: Translational science is integrated across its multiple phases and disciplines within complex populations and across the individual lifespan. • Methods/Processes-Goal: The scientific study of the process of conducting translational science itself enables significant advances in translation.
Targeted Outcomes-UR CTSI Goals- • Clinical and translational research education programs produce skilled multidisciplinary research team members • Local, regional and national partnerships support and enhance clinical and translational science • Researchers and research teams advance clinical and translational science • Clinical and translational research and supporting services are organized within a URMC academic home • A diverse spectrum of community members and organizations are engaged in the research process
Clinical and translational research education programs produce skilled multidisciplinary research team members
KL2 Career Development Program • Institutional K-award program • 2 years, 75% effort • Salary support • Some support for other costs • Research project costs • Travel • Competitive application process • RFA released in July • Applications due ~ October • Awards announced ~ March • Two or three awards each year
TL1 Predoctoral Training Program • Institutional training grant linked to CTSA award • Three types of trainees • Academic Research Track for medical students (year-out program) • PhD students in the Translational Biomedical Sciences Program • MD/PhD students with an interest in translational science • Each trainee receives a stipend and may receive some support for other costs • 10 trainees per year • Mentors and trainees supported by CTSI Mentor Development Core
PhD - Translational Biomedical Science • One of the first of its kind anywhere • Goal: prepare individuals for academic and clinical careers involving the translation of basic biomedical research into clinical strategies to improve health • Required and elective coursework in diverse disciplines • Skill-building workshops and seminars • Research rotations (3 in first year) leading to selection of thesis topic
TL1 Predoctoral Training Program • Academic Research Track • 1 year of support • Medical students apply in December and are selected in February • Options • Pursue MPH or other research-related masters’ degree • Gain hands-on experience in a lab or research center • PhD-TBS students • Multi-year support is possible • MD/PhD students • Multi-year support is possible
Mentor-Protégé Curriculum • At beginning of program year, protégés develop a Research Career Development Plan with their mentors • Mentoring workshops for mentors and protégés • Mentor group meeting • Protégé group meeting • Fall – a member of the Core meets with each protégé • Spring – meeting with mentor-protégé dyad
Other Education Programs • Research Masters’ Degrees (provided by Dept. of Public Health Sciences) • MS – Translational Research • MS – Clinical Investigation • MPH • Non-degree programs • Academic Core Curriculum - fellows and residents – year-long program, weekly meetings • Junior Faculty Academic Core Curriculum – one-week intensive course • Skill-building training • Online training in Comparative Effectiveness Research • Online training in FDA regulatory fundamentals • eRecord for research • REDCap • i2b2 • Annual Scientific Symposium
Local, regional and national partnerships support and enhance clinical and translational science Researchers and research teams advance clinical and translational science
CTSI Research Collaboration & Services • Web-hosted information for easy reference http://www.urmc.rochester.edu/ctsi/research-help/ • Find a range of resources and services to support each stage of research development and operations • Research Help Desk • ResearchHelp@urmc.rochester.edu • Functions as an information hub, supporting research teams • Questions Answered • Resources Identified • Support for study design • Mentors, collaborators and a range of institutional services • Shared resources to include in research plan • Guidance and assistance to navigate regulations and policies
Voucher Program To request a voucher: http://www.urmc.rochester.edu/ctsi/funding/voucher-system.cfm
Voucher Funding by Beneficiary ($000s) Total = $240K since 5/2011
CTSI Project Funding Programs • Pilot Studies • Goal: facilitate new research and future project funding • 1 year, $50,000 • Trainee Pilots • Goal: support trainee research • 1 year, $25,000 • UNYTE Pilots • Goal: stimulate new cross-institutional collaborations • 1 year, $50,000, two or more UNYTE institutions • Novel Biostatistical and Epidemiologic Methods • Goal: stimulate new methods to improve validity, accuracy, scope or speed • 2 years, $20,000 • Incubator Program • Goal: accelerate innovative scientific discovery leading to new research programs • 2 years, $125,000, two or more linked projects
Clinical and translational research and supporting services are organized within a URMC academic home
Clinical Research Center • The CRC provides support for patient-oriented research: • Welcoming In- and outpatient facilities located within the Medical Center (G-5035) and in the Saunders Research Building (1.302) • Experienced assistance in Research Nursing, Bionutrition, and Clinical Research Coordination • The Center accommodates pediatric to adult research subjects. • Access to the Center requires a short application and IRB approval. • Modest fees are charged for services.
Expanding the reach and efficiency of clinical trials through technology • 21st century technology and methodology should expand the availability of clinical research • Clinical trials of new interventions (drugs, devices) will likely benefit the most from these new methods • Using remote access (things like Skype) will permit research participants to be seen at home • Using remote data sensing (like via smart phones) will simplify getting information • Better planning of studies will allow them to be smaller and more efficient
A diverse spectrum of community members and organizations are engaged in the research process
Improving the health of our community(s) • Healthcare delivery will change, driven by ACA and financial forces • URMC is committed to its Community mission • Healthshould improve as healthcare changes • We need to measure what is of most importance to the health of the community and target change in healthcare to the community needs • The CTSI wants to be sure that the community’s needs for healthcare change, and measuring the impacts on community health are a URMC priority • We need to organize how that input is structured so that it is consistently heard and acted upon
National CTSA Directions • Revamped NCATS organization- P Kaufmann • National Steering Committee setting priorities • Site supplements to lead national joint efforts • Future areas of focus uncertain still- recent RFA has substantial changes especially for CRC like structures and pilot funding • Team science essential
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