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Southern California Clinical and Translational Science Institute The SC CTSI Thomas A. Buchanan, MD Founding Director www.sc-ctsi.org Navigating the.

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Presentation on theme: "Southern California Clinical and Translational Science Institute The SC CTSI Thomas A. Buchanan, MD Founding Director www.sc-ctsi.org Navigating the."— Presentation transcript:

1 Southern California Clinical and Translational Science Institute The SC CTSI
Thomas A. Buchanan, MD Founding Director Navigating the University

2 BACKGROUND: CTSAs and SC CTSI
Clinical and Translational Science Awards (CTSAs) Large infrastructure and training grants awarded to ~60 universities across the U.S. The Southern California Clinical and Translational Science Institute (SC CTSI) USC and CHLA’s institute to support clinical and translational science Funded by a CTSA and local institutional support

3 Southern California CTSI at a Glance
Overarching Theme: DIVERSITY Communities: diverse communities of LA Clinical Settings: Keck, CHLA, LAC DHS Academic Disciplines: across USC Scientific Focus: T2-T4 Research Setting: Partners: USC, CHLA, LA County DHS Clinical Trials Health Services Community Training

4 INTERNAL ADVISORY BOARD
People and Programs SC CTSI USC Provost Elizabeth Graddy INTERNAL ADVISORY BOARD DIRECTORS TEAM Institute Director Thomas Buchanan Institute Co-Director Michele Kipke EXTERNAL ADVISORY COMMITTEE Operations & Finance Quinnie Le Programmatic Development Allison Orechwa Evaluation & Improvement Katrina Kubicek EXECUTIVE TEAM Clinical Research Support April Armstrong John Wood Community Engagement Michele Kipke Research Development Sarah Hamm-Alvarez Workforce Development Cecilia Patino-Sutton Steven Siegel Biostatistics Wendy Mack Regulatory Support Eunjoo Pacifici Clinical Research Informatics Daniella Meeker Juan Espinoza Implementation and Health Delivery Science Amy Towfighi. MD

5 SC CTSI Resources and Services
CONSULTATIONS Biostatistics Community-Engaged Research Digital Scholarship Human Studies and Trials Managing Data in REDCap Research Ethics Translational Research Team Building CLINICAL RESEARCH SUPPORT Navigator Study Design Recruitment Study Coordinators Regulatory Support Budget and Coverage Analysis Scientific Review Voucher Program Clinical Trials Units CLINICAL RESEARCH INFORMATICS Clinical Data Services Clinical Trial Management System (CTMS) Clinical Research Data Warehouse (DEWARS) Local Study Participant Discovery Tool (i2b2) Los Angeles Data Resource (LADR) National Study Participant Discovery Tool Data Management Tool (REDCap) TRAINING AND EDUCATION Training Video Library Institutional Career Development Program (KL2) Digital Scholar Program TEAM BUILDING AND FUNDING Pilot Awards Team Building Vouchers Team Building Toolkit COMMUNITY ENGAGEMENT Community-Engaged Research Services for Researchers Services for Community Members Our Partners SEARCH TOOLS Clinical Studies Directory Research Training Finder Research Expert Finder (PROFILES)

6 Clinical Research Support (CRS): Research Services
Biostatistics and data management support Study coordinators Recruitment support Budget assistance for IITs Multi-site study planning and conduct Regulatory support (IND/IDEs, auditing, monitoring) Clinical Trials Unit (medium-to-high complexity studies) Above services available at USC and CHLA* Director (USC): April Armstrong, MD, MPH Director (CHLA): John Wood, MD, PhD Contact: Nicki Karimipour, PhD (USC) usc.edu Contact: Shannen Nelson, RN MSN (CHLA) Analogous office at CHLA with similar services Recharge model associated with some of these services is included in Supplemental Slides at the end *Availability of services may vary between USC and CHLA CRS offices Contact: Wendy Mack, PhD (USC) Contact: Ji Hoon Ryoo, PhD, Contact: Shannen Nelson, RN MSN (CHLA)

7 SC CTSI Study Navigation Tool
An e-tool to help you determine where to submit your clinical research study at USC contracting offices, review committees, ancillary services. You answer drop-down questions The tool provides primary units and systems you need to interact to activate a clinical study. sc-ctsi.org/resources/new-study-navigation-tool

8 Patient Data Resources
Sample Size Planning / Feasibility Assessment (i2b2) Counts of patients with specific characteristics Self serve, no IRB approval required Chart Screening and Recruitment Chart access and/or patient contact information Requires IRB approval (request is imbedded in IRB iStar application) Health Economics, Data Mining, and Outcomes Research de-identified data or limited data sets for retrospective analysis Request imbedded in the IRB iStar application Data provided in HIPAA compliant cloud environment Informatics Director Daniella Meeker, PhD USC Informatics Co-Director Juan Espinoza, MD CHLA

9 USC Health Science Profiles
Who publishes in a field Profiles of Researchers

10 Clinical Studies Directory of USC
clinicaltrials.keckmedicine.org Free, participant-friendly public landing page for studies Allows interested participants to send an to a study coordinator Can be linked to social media for digital recruitment

11 Mentored Career Development (KL2) Program
3-Year Mentored Career Development Program for junior faculty members who are clinically trained and wish to pursue a career in clinical and translational research Four scholars per year selected by peer review of application and interview Training includes course work, seminars and workshops, directed research, mentoring Scholar’s receive Salary support up to $90,000 plus fringe for a minimum of 75% effort (minimum of 50% for surgical specialties upon NIH approval). Tuition/research/travel costs of up to $25,000  annually for three years: Scholars academic unit pays one year, CTSA and Provost pay two years Graduates (n=24) have 606 publications and $45M in extramural funding Steve Siegel MD, PhD Cecilia Patino-Sutton MD, MPH Contact: Jeanne Dzekov-McKean

12 Education and Training Dozens of courses, lectures, workshops
Highlights Intro to Clinical Translational Research 3-course series Research in Diverse Populations - short course Regulatory Science workshops Team Science workshops Career Development seminars REDCap (data acquisition and management too) workshops One-on-one R01 application counseling Online training finder Visit our online library

13 Community Engagement Advice and assistance for connecting with diverse, hard-to-reach populations Facilitate academic-community partnerships; toolkits Integration of community health workers – promotoras Community-engaged research projects Virtual navigator Research Ambassadors program Los Angeles Community Engagement Research Core Hollywood Health & Society Michele Kipke PhD Katrina Kubicek PhD Educating the community about research opportunities Leveraging academic and community partnerships Community Advisory Boards Toolkits and support in creating a CAB to integrate community perspective throughout the research study CE research: Autism Disparity Program LA-CERC: promoting community engaged research in the LA community Hollywood Health and Society: provide entertainment industry with accurate info about health and hope to integrate compelling and realistic storylines about clinical research into popular TV programs Contact: Mayra Rubio-Diaz

14 Research Development Pilot funding and voucher programs to support multidisciplinary research teams Promote, catalyze and support collaborative cross- disciplinary teams and projects Education & training: Seminars, workshops (i.e. grant writing) Grant application pre-review Consultations Director: Sara Hamm-Alvarez, PhD Provide pilot funds to catalyze multidisciplinary teams to conduct innovative research projects that test the feasibility of novel technologies, methodologies and approaches to address challenges in clinical research and health problems of our diverse communities. TEAM SCIENCE OBJECTIVES Promote, catalyze and support collaborative cross-disciplinary teams and projects Provide education and training to expand workforce capabilities in team science Continue to foster changes in the academic environment to ensure appropriate recognition and reward of research team members Contact: Juli Wu, PhD Aileen Dinkjian, MPH usc.edu

15 SC CTSI Funding Opportunities
$40,000 pilot grants (~10 per year) Clinical or community research projects Methods to improve clinical research methods and processes Next application due date October 7, 2019 $75,000 implementation science grants (1 per year) Implementation science projects in LA County Health System FY20 Cycle Announcement coming soon Small Grants and Vouchers $3,000 team building grants (up to per year available) $3,000 clinical research vouchers (~20 per year available) Continuous submissions

16 Questions?

17 Questions?


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