An Introduction to the University of Florida Clinical and Translational Science Institute

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An Introduction to the University of Florida Clinical and Translational Science Institute. Mike Conlon, PhD COO, UF CTSI. Translational Research. T1. T2. T3. T4. Population Practice. Potential Application. Safe & Effective. Clinical Practice. Health of Community or Population.
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An Introduction to the University of FloridaClinical and Translational Science InstituteMike Conlon, PhDCOO, UF CTSIThe UF CTSI is supported in part by NIH awards UL1 RR029890, KL2 RR029888 and TL1 RR029889Translational ResearchT1T2T3T4Population PracticePotential ApplicationSafe & EffectiveClinical PracticeHealth of Community or PopulationPotential Clinical ApplicationEvidence-Based GuidelinesClinical Care or InterventionBasic Science DiscoveryBasic KnowledgeTheoretical KnowledgeEfficacy KnowledgeAppliedKnowledgePublic HealthKnowledgeTypes of Research:
  • Physiology
  • Engineering
  • Animal Models
  • Phase 1 Trials
  • Clinical Trials
  • Cohort Studies
  • Observational studies
  • Chart reviews
  • Comparative Effectiveness
  • Health Services
  • Clinical Outcomes
  • Adoption
  • Social determinants of health
  • Population / outcome
  • Health Policy
  • Policy impact
  • The UF CTSI is supported in part by NIH awards UL1 RR029890, KL2 RR029888 and TL1 RR029889National Institutes of Health Clinical And Translational Science AwardsThe UF CTSI is supported in part by NIH awards UL1 RR029890, KL2 RR029888 and TL1 RR029889
  • In 2006, NIH developed the Clinical and Translational Science Award program (CTSA) led by the National Center for Research Resources
  • CTSA works together as a national consortium of institutions sharing a common vision to improve human health by transforming the research and training environment to enhance the efficiency and quality of clinical and translational research – helping scientists bridge laboratory discoveries to patient treatments and health
  • Now fully implemented, 60 institutions transform the local, regional, and national environment to increase the efficiency and speed of clinical and translational research across the country
  • National Consortium of 60 Academic Health CentersThe UF CTSI is supported in part by NIH awards UL1 RR029890, KL2 RR029888 and TL1 RR029889How did UF get here?The UF CTSI is supported in part by NIH awards UL1 RR029890, KL2 RR029888 and TL1 RR029889
  • In July of 2009, UF received a $26 million, five year, NIH Clinical and Translational Science Award, establishing the UF CTSI
  • The UF Office of Research provided an additional $23 million in support
  • The UF College of Medicine has made $70 million in commitments
  • All 16 UF colleges  effort for staff, faculty, space, equipment
  • The result: an institute whose mission is to improve human health by accelerating the translation of scientific discoveries into the common practice of good health and health care.
  • A Catalyst for CollaborationThe UF CTSI is supported in part by NIH awards UL1 RR029890, KL2 RR029888 and TL1 RR029889UF CTSI OrganizationThe UF CTSI is supported in part by NIH awards UL1 RR029890, KL2 RR029888 and TL1 RR029889Participant and Clinical Interactions ProgramCarl Pepine, MD The UF CTSI is supported in part by NIH awards UL1 RR029890, KL2 RR029888 and TL1 RR029889
  • Overarching goal
  • Create new opportunities for patient-oriented research
  • Clinical Research Units
  • Locations: Gainesville (UF and VA), Jacksonville, Orlando
  • Disease expertise: Aging, Cancer, Cardiovascular, Dental, GI/Hepatobiliary, Neuromedicine, Pain and Sensory Testing, Sleep Disorders, Tuberculosis and Emerging Pathogens
  • Facilities: Phase 1: Center for Clinical trials (24 bed unit); Phase 1-3: Clinical Research Center (Gainesville and Jax), inpatient / outpatient clinical trial needs
  • Scientific Review Process
  • Research Design and AnalysisJon Shuster, PhDThe UF CTSI is supported in part by NIH awards UL1 RR029890, KL2 RR029888 and TL1 RR029889
  • Overarching goal
  • Consult, collaborate and conduct research and educate on study design and biostatistical issues in CTS.
  • Activities
  • Study Design – clinical trials, observational studies, cohort, chart review, qualitative, epidemiologic
  • Power Analysis
  • Study Analysis
  • Data presentation and visualization
  • Regulatory Knowledge and Research SupportWajeeh Bajwah, PhDThe UF CTSI is supported in part by NIH awards UL1 RR029890, KL2 RR029888 and TL1 RR029889
  • Overarching goal
  • To increase accessibility of information by providing expert investigator assistance via Research Project Navigators, and provide prompt access to research and training resources ensuring rapid activation of research
  • Services provided
  • Trial database (RedCap)
  • Forms design
  • Quality assurance
  • Clinical and research ethics
  • Regulatory affairs
  • IRB assistance
  • Contract negotiations
  • Billing and budgeting
  • Technology transfer
  • Biomedical InformaticsMichael Conlon, PhD The UF CTSI is supported in part by NIH awards UL1 RR029890, KL2 RR029888 and TL1 RR029889
  • Overarching Goal
  • Develop and integrate clinical and research data systems to support collaborative CTS and lay groundwork for new academic program in BMI
  • Activities
  • Integrated Data Repository
  • Study Registry
  • CTSI Portal
  • Support Systems – help desk, billing, vouchers, tracking, reporting
  • Research Discovery and Collaboration (VIVO)
  • CTS infrastructure – REDCap, Research Match, Study and Network portals, specialized system R&D
  • Translational Technologies and ResourcesJesse Gregory, PhDThe UF CTSI is supported in part by NIH awards UL1 RR029890, KL2 RR029888 and TL1 RR029889
  • Overarching Goal
  • Develop and Provide basic science tools and services for research
  • Cores
  • Biorepository
  • Genotyping
  • Human Imaging
  • Targeted Metabolomics
  • Global Metabolomics
  • Peptide Radioidionation
  • Training and Professional Development ProgramMarian Limacher, MD The UF CTSI is supported in part by NIH awards UL1 RR029890, KL2 RR029888 and TL1 RR029889
  • Overarching Goal
  • Train a new generation of multi-disciplinary CTS researchers and leaders in academia, industry and government.
  • Programs
  • KL2 Multidisciplinary Program for Junior Faculty
  • TL1 Pre-doctoral training program
  • Advanced Postgraduate Program in Clinical Investigation
  • Research Coordinator Training
  • Masters in CTS
  • MD-PhD
  • Affiliated Programs
  • Junior Honors Medical Program
  • Center for Precollegiate Education and Training
  • Center of Excellence for Regenerative Health Biotechnology
  • HHMI Science for Life
  • Health Science Center Training
  • Interdisciplinary Program in Biomedical Sciences
  • Integration of CTSI Training ProgramsThe UF CTSI is supported in part by NIH awards UL1 RR029890, KL2 RR029888 and TL1 RR029889Community Engagement and ResearchLinda Cottler, PhD Elizabeth Shenkman,PhDMobeen Rathore, MD Activities-Community Advisory Boards-Community Research Associates-HealthStreet-UF-FSU Collaborative Research Program-JaxHero PBRNThe UF CTSI is supported in part by NIH awards UL1 RR029890, KL2 RR029888 and TL1 RR029889Overarching GoalTo promote collaborative relationships with communities to address the health and well-being of community membersCommunications ResearchDeborah Treise, PhD The UF CTSI is supported in part by NIH awards UL1 RR029890, KL2 RR029888 and TL1 RR029889
  • Overarching Goal
  • Advance our knowledge of communication processes related to clinical care and public health
  • Activities
  • Studies of risk communication in surgery and genetics
  • Studies of communications in health disparity settings
  • Pilot and Collaborative ProjectsChris Batich, PhD The UF CTSI is supported in part by NIH awards UL1 RR029890, KL2 RR029888 and TL1 RR029889
  • Overarching Goal
  • Support emerging research via institution-wide RFAs for CTS, targeting junior faculty; methods (IP) development; and multi-discipline, trans-college initiatives.
  • Activities
  • Three RFAs in 2011. Seventeen awards.
  • Personalized MedicineJulie Johnson, PhD The UF CTSI is supported in part by NIH awards UL1 RR029890, KL2 RR029888 and TL1 RR029889
  • Background
  • Human genome project completed in 2001
  • Collins, NIH: expectation that an individual’s personal genome will be part of their medical record, from which information can be pulled to determine disease risk or guide treatment decisions
  • Challenge
  • Despite the substantial number of important genetic discoveries made, there are limited examples of translation to practice
  • UF Opportunity
  • Build a genetic data repository
  • Link with clinical information for research and clinical care (IDR); Clinical implementation teams; Clinical laboratory genotyping, validation, and data interpretation; Biomedical informatics; IRB and genetic counseling
  • Improving Clinical Research Infrastructure: Ongoing Projects 2011The UF CTSI is supported in part by NIH awards UL1 RR029890, KL2 RR029888 and TL1 RR029889
  • UF-FSU community research collaborative program
  • Comprehensive Study Registry with T1-T4 metrics
  • Integrated data repository
  • Clinical Translation in Pharmacogenomics
  • Clinical and Translational Research Building (CTRB)
  • VIVO: Enabling National Networking of Scientists
  • Improved efficiency for protocol submission
  • Click commerce for IRB implementation
  • Billing and budget tool
  • Gator Advantage for Research subjects
  • Cores: Biorepository, Metabolomics, Human imaging
  • Consent for recontact and use of tissue
  • UF-FSU Community Research ProgramGoal: Create new opportunities for practicing physicians, clinical scientists, students, and the citizens of Florida to collaborate in advancing research and education into the causes, prevention, diagnosis, treatment and cure of human disease. The UF CTSI is supported in part by NIH awards UL1 RR029890, KL2 RR029888 and TL1 RR029889Comprehensive Study RegistryOver 5700 human subject studies approved by 4 UF IRBs from 2008 to date. Web site for potential research participants to find opportunitiesThe UF CTSI is supported in part by NIH awards UL1 RR029890, KL2 RR029888 and TL1 RR029889Integrated Data Repository
  • Current Researcher Dilemma – no data
  • The researcher needs to know if there are enough patients in the institution’s health system to propose a research project to sponsors for approval.
  • Researchers may need to refine a hypothesis, which is currently a challenge without access to any data.
  • The Results??
  • Researcher cannot submit for a grant without realistic estimates of subject recruitment, or
  • Research is approved and initiated, cannot be completed due to lack of appropriate subjects
  • Wastes time and resources
  • Places study subjects at potential risk with no research gain
  • The Solution – The Integrated Data Repository (IDR)
  • Helps the researcher by allowing ad hoc queries for cohort discoveries, in a secure environment that protects patient privacy.
  • The UF CTSI is supported in part by NIH awards UL1 RR029890, KL2 RR029888 and TL1 RR029889Clinical Translation in PharmacogenomicsClopidogrel (Plavix): genetic polymorphism of CYP2C19 leads to reducedability to activate clopidigrel and increased risk of cardiovascular complication“Front door” consenting; Bioethics; Communications ResearchCardiovascular CRU; Comparative Effectiveness ResearchBiorepositoryGenotyping CoreBiomedical Informatics;Hospital IT; EpicIntegrated Data Repository; Bioinformatics; Research ITThe UF CTSI is supported in part by NIH awards UL1 RR029890, KL2 RR029888 and TL1 RR029889Clinical and Translational Research Building
  • CTSI headquarters
  • Ambulatory Clinical Research Center and targeted research programs
  • Biostatistics, BMI, Epidemiology, and Health Policy
  • Training Programs (pre and post doctoral)
  • 80,000 ft2 dedicated space
  • Incorporated with Institute of Aging (NIH funded; 40,000 ft2)
  • January 2013
  • The UF CTSI is supported in part by NIH awards UL1 RR029890, KL2 RR029888 and TL1 RR029889VIVO: Enabling National Networking of ScientistsThe UF CTSI is supported in part by NIH awards UL1 RR029890, KL2 RR029888 and TL1 RR029889NIH-funded effort to create an open semantic network of information and tools regarding scientists, their interests, activities and accomplishmentsSeven school development consortium led by UFFifty additional implementations underway. Dozens of partnersFind people, grants, papers, data, concepts, resources, events, data, studies, projects within and across institutions http://vivoweb.orgImproving Protocol SubmissionThe UF CTSI is supported in part by NIH awards UL1 RR029890, KL2 RR029888 and TL1 RR029889
  • Single research price list
  • Simple confirmation of service
  • Applies to all clinical studies using Shands services
  • Click Commerce for IRB
  • On-line protocol submission
  • Simplified process
  • Budgeting tool
  • Simplified clinical trial budget creation based on current service rates
  • For More InformationThe UF CTSI is supported in part by NIH awards UL1 RR029890, KL2 RR029888 and TL1 RR029889
  • On the web
  • www.ctsi.ufl.edu
  • Call
  • 352-273-8700
  • Email
  • info@ctsi.ufl.edu
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