1. Southern California Clinical and Translational Science Institute The SC-CTSI Thomas Buchanan MD, Director Michele Kipke, PhD, Co-Director www.sc-ctsi.org

2. What is the SC-CTSI?  It an institute that promotes and supports clinical and translational research to improve health, in particular for diverse populations  It a partnership among USC, CHLA, Los Angeles County Department of Health Services, and more than sixty community organizations which work together to define research priorities, develop and support research, and disseminate results to improve health  It a supported by a Clinical and Translational Science Award from NIH and from strong institutional support from USC and CHLA www.sc-ctsi.org

3. Three Main Areas Supported by the SC-CTSI  Clinical Trials and Studies  Clinical trials of novel therapeutic approaches  Development of novel diagnostics and biomarkers  Human mechanistic studies  Methods to enhance clinical research processes  Community Partnered Research  Identify research priorities  Engage community members in research  Disseminate findings to the community  Training and Career Development  Mentored career development program (KL2)  Courses, seminars, workshops for faculty, staff, trainees, community

4. The SC CTSI Team Tom Buchanan Director Michele Kipke Co-Director Quinnie Le Ops and Finance Allison Orechwa Program Development A. Armstrong, J. Wood Clinical Research Support Daniella Meeker Informatics Jon Samet Workforce Development Michele Kipke Community Engagement Katja Reuter Digital Innovation Sarah Hamm-Alvarez Research Development Wendy Mack Biostatistics Katrina Kubicek Evaluation & Improvement

5. SC-CSTI: Clinical Research Support (CRS) Single stop for accessing expertise, services and infrastructure to design and conduct clinical trials (non-cancer; CISO supports cancer trails)  Navigator  Study Coordinator Pool  Recruitment Strategies  Regulatory Support (INDs, auditing, monitoring)  Budgeting and Coverage Analysis  Clinical Trials Unit  Scientific and Feasibility Review Contact: Diana Palma, BS, CCRP - Research Navigator (323)442-1038, Diana.Palma@med.usc.eduDiana.Palma@med.usc.edu

6. SC CTSI: Clinical Trials Unit Dedicated unit for medium to high complexity studies High precision (PK/PD, special procedures) High Risk (first in human, intensive monitoring, biopsies) High complexity (infusions, complex processing) Body composition by DEXA, Research-trained staff, including research nurses, phlebotomists, lab technicians One on the HSC, one at CHLA

7. SC-CSTI: Biostatistics Expert advice across the life of your study  Design a study Choosing a study design Estimation of sample size and power Statistical analysis plans  Manage a study Advice on general data management (REDCap) Assist with reporting during a study  Statistical analysis Perform statistical analysis Assist with interpretation of results Creation of tables and figures  Scientific Writing Manuscript preparation Writing support Responding to reviewers  Other biostatistical issues Biostatistics Charge-Back Structure Standard Rate: $125/hr Initial consultation free: up to 1 hour Supplemental support for junior researchers: SC CTSI Pilot Funding Awardees: up to 2 hours Junior Investigators: up to 5 hours/yr K scholars: up to 15 hours/yr T trainees: up to 15 hours/yr Extramural Grant Planning: up to 3 hours/grant PM516 Volunteers: up to 5 hours/project

8. SC-CSTI: Biostatistics www.sc-ctsi.org

9. Clinical Research Informatics  DEWARS data warehouse: a single and integrated repository of clinical and research data sources to support research and analytic needs across USC & CHLA  Clinical Trials Management System: software for managing budgeting, contracting, coverage analysis, enrollment, participant visits, billing and collections for clinical trials  Health Research Computing Cloud: a self-service portal for high-performance computing and data archiving in HIPAA compliant environment (under development)  Data Development Services: assistance with data collection and management strategies  REDCap: free, secure and HIPAA-compliant data capture and storage tool

10. DEWARS: What Can You Do Now? Study Planning and Power Analysis: Self-service website to find number of patients at CHLA and Keck that meet your study inclusion and exclusion criteria. Request an account at i2b2@usc.edui2b2@usc.edu Screening and Recruiting: With IRB approval, get medical record numbers for additional screening and/or contact information for recruiting. Pilot: 1.2 Million Patient Records From CHLA and Keck

11. DEWARS: What’s Next? Health Outcomes and Implementation Science (Dec. 2016): Access to high-quality clean data sets from health systems. Expansions to Partner Health Systems (2016): –Los Angeles Data Resource – Cedars-Sinai, City of Hope, UCLA –Patient-Centered Scalable Network for Effectiveness Research – DHS, 5 University of California Medical Centers, AltaMed, QueensCare Family Clinics, Children’s Clinic of Long Beach, Veteran’s Administration, Intermountain Health Enhancements with Geocoded and mHealth Data (2017): Incorporating place-based data to create patient profiles enriched with environmental exposure data and behavioral health data.

12. Clinical Research Informatics

13. SC CTSI Community Engagement  LA Community Engagement Research Core: One-Stop shop for community engagement  Faculty consultations and team building  Community Advisory Boards  Toolkits and support in creating a CAB for research studies to ensure community perspective is integrated throughout the research study (e.g., research questions, design, recruitment, interpretation, dissemination)  Training and Capacity Building  Community Engaged Research 101  Cultural Competency Boot Camp  Participant Recruitment  Research Ambassadors in community settings  Strategies and access to hard-to-reach populations

14. SC CTSI Community Engagement

15. SC-CTSI Workforce Development  Mentored Career Development (KL2) Program  Three years of commitment and support at 75% effort  Home department has to pay one year, program pays the rest  Didactic training, hands on research, career development  Masters degree and certification options  Mentor “match-making”; Mentoring and mentee workshops  Clinical Research Coursework, Seminars, Workshops for faculty, staff, students and training

16. SC-CTSI Workforce Development

18. SC-CTSI Digital Innovation  Developing cutting edge digital approached to support clinical research  Social medial recruiting (twitter, facebook)  Clinical Studies Directory (community access to >500 trials)  Research Expert Finder (Profiles)  Research Training Finder (what you need to be in compliance)  Digital Scholars Program - Helping researchers expand their impact through digital technologies  Recruitment  Crowd funding  Collaboration  Dissemination  Alternative metrics

19. SC-CTSI Digital Innovation

20. SC-CTSI Research Development  Team Science Workshops  How to build effective teams  Pilot Funding Program (~$400k/year)  Clinical Research Pilot (up to $40K, applications due Sept 21, 2016)  Collect preliminary data to develop new externally funded clinical and translational research (e.g., clinical trial, community trial, health outcome study, health implementation study)  Research Processes and Methods (up to $40K, applications due Sept 21, 2016)  Conduct research to improve processes in clinical and translatoinal research (e.g., efficiency, effectiveness, safety, cost effectiveness)  Team Development (up to $5K, open applications year round)  To host a conference or workshop to encourage the assembly of new teams or the development of the science of a team science  Mock Study Section (with Workforce Development)  Provide Jr. Investigators and graduate students feedback on grant proposals in NIH like study section format

21. SC-CTSI Research Development

22. Thank You SC CTSI | www.sc-ctsi.orgwww.sc-ctsi.orgPhone: (323) 442-4032Email: info@sc-ctsi.orginfo@sc-ctsi.orgTwitter: @SoCalCTSI