May 9, 2019

1. The UCLA Clinical and Translational Science Institute Data and Research Resources May 9, 2019 Steven Dubinett, MD Director, UCLA CTSI Associate Vice Chancellor for Research www.ctsi.ucla.edu▪bringing CTSI innovations to the greatest health needs in Los Angeles

2. UCLA CTSI Partner Institutions • Public research university with leading medical, dental, public health, nursing, engineering, business and life sciences • Cedars-Sinai is the largest nonprofit hospital in the western United States • A private, minority-serving institution located in under-resourced South Los Angeles • Public teaching and research hospital; its catchment area of 3 million residents includes 550,000 below the poverty level • One of the largest health care facilities within the Department of Veterans Affairs with 1.4 million veterans in their service area In Discussion

3. Mission and Vision MISSION Bring UCLA CTSI innovations to bear on the greatest health needs of Los Angeles and the nation. VISION Catalyze research that translates discoveries into tangible improvements in health care, disease prevention and the health of our community. 3

4. Programs • Informatics • Community Engagement in Research • Team Science • Workforce Development • KL2 & TL1 Training Programs • Pilot Program • Biostatistics • Participant and Clinical Interactions • Regulatory • Special Populations • Network Resources – Trial Innovation Network • Population Health • Precision Health www.ctsi.ucla.edu

5. Contact the Informatics Program Marianne Zachariah Program Administrator Alex Bui, PhD Program Co-leader Douglas Bell, MD, PhD Program Leader Contact the CTSI Informatics Program:patientdata@mednet.ucla.edu.

6. Informatics Program Services • Honest Broker Services • Clinical Data requests • Consulting and assistance with: • Complex data bases • Clinical data access • Online, email prompted surveys • Terminology systems • Informatics tools Contact the CTSI Informatics Program: patientdata@mednet.ucla.edu.

7. The “Honest Broker” Process for Research Electronic Health Record Recruitment Outreach Data Files Retrospective Analysis (with Office of Health Informatics & Analytics and CTSI Biostatistics Program) -specific data -specific patients Since 2013 682 Projects 29 Million Pt Records Machine Learning (with OHIA, CTSI Biostatistics and Clinical Pathways Program)

8. Tools that Provide Patient Counts – Find Cohorts, Write Grants • i2b2 • Implemented at UCLA, Cedars, Harbor • Each site maintains its own data individually • Los Angeles Data Resource (LADR) • Cedars, City of Hope, UCLA, and USC Keck • 6.5 million patient records searchable in one system • CHLA and clinics affiliated with Charles Drew are in progress • Accrual to Clinical Trials (ACT) • Search 35 CTSAs across the nation • Available now • Includes UC medical campuses at San Francisco, San Diego, Irvine and Davis Contact the CTSI Informatics Program: patientdata@mednet.ucla.edu.

9. Searches in LADR and ACT • Medications • Demographics • Pediatric and adult age ranges • ICD-9 and ICD-10 codes • CPT codes • Laboratory tests • Vital signs • Vital status • Visit details Contact the CTSI Informatics Program: patientdata@mednet.ucla.edu.

10. ACT: The Clinical Research Cycle www.actnetwork.us/National STUDY DESIGN COHORT DISCOVERY FEASIBILITY RECRUITMENT COLLABORATION FUNDING ETHICS / COMPLIANCE

11. Programs • May 16, 10-11 AM • Nearly 300 investigators attended training webinars in 2018 • Learn how to: • Search 6.5M+ de-identified patient records • Expand a study from single to multi-site • Obtain patient counts from all institutions w/ one query • Inform NIH Inclusion Enrollment Reports w/ patient counts by gender, race and ethnicity • Increase cohort identification for rare disease studies • Obtain coordinated data provisioning support

12. Biostatistics, Epidemiology and Research Design (BERD) Services David Elashoff, PhD Program Leader • Email: domstat@mednet.ucla.edu • Website: http://domstat.med.ucla.edu Services • Database Consulting • REDCap • Data provisioning consults in collaboration with the Informatics Program • Cloud-based repositories • Infrastructure for clinical trials database • Data Analysis • Grant Collaboration • Study design • Analytic plans • Data management • Trial Design • Bioinformatics • Manuscript preparation

13. Drop-In Biostatistics Consults Drop-in consults • 12-1 PM every Wednesday & 1-3 PM every Friday • Location: 1100 Glendon Avenue, Suite 1820 Los Angeles, CA 90024 • Email: domstat@mednet.ucla.edu • Website: http://domstat.med.ucla.edu • Phone: 310-794-3111, Fax: 310-794-8149

14. www.researchgo.ucla.edu

15. Phase 1 Developmental Therapeutics and Gene Therapy Unit • Initiation and conduct of early-phase clinical pharmacology, investigational device and gene therapy studies in healthy volunteers, special populations (including children) over a spectrum of diseases • Integrated within the UCLA CTSI CTRC • Seamless integration with UCLA investigational pharmacy • Support for: • Intensive PK evaluations/prolonged stays/overnights (i.e. 1,2,4,6,12, 24hr PK draws) • Dose Escalation • Single/multiple dose studies • First-in-human • Bioavailability/Bioequivalence • Drug-drug interaction • Food effect • Thorough QT/QtC

16. CTSI K and Career Development Award Workshop • Date and location • June 13 • UCLA Division of General Internal Medicine & Health Services Research • Registration deadline May 23 • Go to CTSI website www.ctsi.ucla.edu • Space is limited

17. Grant Library https://www.ctsi.ucla.edu/funding/pages/sample >350 Current users 75 Total # grants

18. CTSI Funding Opportunities • Catalyst Awards • Up to $5K for conferences, seminars and team-building activities • Next round opens July 1 • DGSOM Theme Funding, partnered with CTSI and Institute of Precision Health • Two-phase process: Planning grants up to $1K; Seed grants up to $250K • Core Vouchers • Vouchers worth up to $10K for core services at UCLA and CTSI partner institutions, next round spring 2020 • Team Science Awards partnered with • Iris Cantor Women’s Health Center • Center for Autism Research and Treatment • Center for AIDS Research – LOI due May 17 • Center for Ulcer Research and Education – next round opens fall 2019 • Center for Study of Opioid Receptors and Drugs of Abuse (CSORDA) – applications due May 15

19. Contact the Informatics Program Marianne Zachariah Program Administrator Alex Bui, PhD Program Co-leader Douglas Bell, MD, PhD Program Leader Contact the CTSI Informatics Program: patientdata@mednet.ucla.edu