Lisa LaVange, PhD, Professor and Associate Chair, Department of Biostatistics, UNC-Chapel Hill Gillings School of Global Public Health; Director, Collaborative Studies Coordinating Center, UNC-Chapel Hill Gillings School of Global Public Health

John Preisser, PhD, Professor, Department of Biostatistics, UNC-Chapel Hill Gilllings School of Global Public Health

Til Stürmer, MD, MPH, PhD, Nancy A. Dreyer Distinguished Professor and Chair, Department of Epidemiology, UNC-Chapel Hill Gillings School of Global Public Health

Jessica Young, MSPH, Doctoral Student, Department of Epidemiology, UNC-Chapel Hill Gillings School of Global Public Health

TRIANGLE COMPARATIVE

EFFECTIVENESS RESEARCH

SYMPOSIUM

RTI International

Horizon Auditorium

3040 E. Cornwallis Road

Research Triangle Park, NC

May 7, 2019

Please visit the posters showcased in the rear of the room during all breaks!

SYMPOSIUM PLANNING COMMITTEE

INVITED ABSTRACTS FOR POSTER PRESENTATION

Timothy Carey, MD, MPH, Co-Principal Investigator, NC TraCS Institute; Sarah Graham Kenan Professor of Medicine, Departments of Medicine and Social Medicine, UNC-Chapel Hill School of Medicine; Adjunct Professor, Department of Epidemiology, UNC-Chapel Hill Gillings School of Global Public Health

Lisa Gehtland, MD, Public Health Analyst, Center for Newborn Screening, Ethics, and Disability, RTI International

Greta Herring, Administrative Assistant III, Center for Newborn Screening, Ethics, and Disability, RTI International

Abigail Haydon, MPH, PhD, Research Program Manager, NC TraCS Institute, UNC-Chapel Hill

Michele Jonsson Funk, PhD, Associate Professor, Department of Epidemiology, UNC-Chapel Hill Gillings School of Global Public Health; Director, Center for Pharmacoepidemiology, UNC-Chapel Hill Gillings School of Global Public Health

“Testing a Multi-Criteria Decision Analysis Tool to Support Decision Making Around Child Neglect Prevention Intervention Selection for Implementation” — Gracelyn Cruden, MA, Doctoral Student, Department of Health Policy and Management, UNC-Chapel Hill Gillings School of Global Public Health

“Long-term Outcomes Following Mid-Urethral Mesh Sling Surgery for Stress Urinary Incontinence” — Sara Z. Dejene, BS, Masters/Doctoral Student, Department of Epidemiology, UNC-Chapel Hill Gillings School of Global Public Health

“Optimizing CER in Symptomatic Uterine Fibroids With Development of a Machine-Learning Enhanced Computable Phenotype For Use With EHR” — Sarah R. Hoffman, MS, MPH, Doctoral Candidate, Department of Epidemiology, UNC-Chapel Hill Gillings School of Global Public Health

“Estimating Real-World Treatment Effects in the Presence of Cross-Over of Preferred Treatment Choice: An Example of Oral Glucose Lowering Medications” — Phyo T Htoo, MD, MPH, Doctoral Student, Department of Epidemiology, UNC-Chapel Hill Gillings School of Global Public Health

“Transporting Outcomes From Randomized Trials to a Population of Interest: Suicidality Among US Adults in Routine HIV Care” — Katie R. Mollan, MS, Doctoral Student, Department of Epidemiology, UNC-Chapel Hill Gillings School of Global Public Health

“Agent-Based Modeling to Estimate the Economic Impact of Substandard and Falsified Antimalarials in Nigeria” — Sarah Laing, MPH, Research Associate, Division of Practice Advancement and Clinical Education, UNC-Chapel Hill Eshelman School of Pharmacy

“Temporal Trends in Opioid Prescription Dispensing Among Commercially Insured Children and Adolescents Undergoing Outpatient Surgery in the United States, 2000-2015” — Shahar Shmuel, ScM, Doctoral Student, Department of Epidemiology, UNC-Chapel Hill Gillings School of Global Public Health

“Characterizing Opioid Overdose Using NC EMS Data” — Josie Caves Sivaraman, MSPH, Doctoral Student, Department of Epidemiology, UNC-Chapel Hill Gillings School of Global Public Health

“Bias Reduction with Multiple Imputation of Lab Results From a Limited Internal Sample” — Tiansheng Wang, PharmD, Doctoral Student, Department of Epidemiology, UNC-Chapel Hill Gillings School of Global Public Health

Visit NC TraCS CER at tracs.unc.edu/cer

8:00 — 8:30 am REGISTRATION continental breakfast and coffee served*

8:30 — 8:45 am

WELCOME AND INTRODUCTIONS

Timothy Carey, MD, MPH, Co-Principal Investigator, NC TraCS Institute; Sarah Graham Kenan Professor of Medicine, Departments of Medicine and Social Medicine, UNC-Chapel Hill School of Medicine; Adjunct Professor, Department of Epidemiology, UNC-Chapel Hill Gillings School of Global Public Health

8:45 — 9:05 am

Considering the Evidence: What is Substantial?

Lisa LaVange, PhD Professor and Associate Chair, Department of Biostatistics, UNC-Chapel Hill Gillings School of Global Public Health; Director, Collaborative Studies Coordinating Center, UNC-Chapel Hill Gillings School of Global Public Health

9:05 — 10:25 am

Paving the Way for Real-Word Evidence

Moderator: Til Stürmer, MD, MPH, PhD Nancy A. Dreyer Distinguished Professor and Chair, Department of Epidemiology, UNC-Chapel Hill Gillings School of Global Public Health

Multi-Database Study Accepted by FDA in Place of a Cardiovascular Outcomes Trial in Drug Approval: Case Study of PrucaloprideElizabeth B. Andrews, PhD Vice President of Pharmacoepidemiology and Risk Management, RTI Health Solutions, Research Triangle Park, NC

Advances in the Use of Real-World Evidence for Medical Devices: The National Evaluation System for Health Technology (NEST)Rachael Fleurence, PhD Executive Director, National Evaluation System for Health Technology Coordinating Center (NESTcc), Arlington, VA

Industry Perspective on the Use of Real-World Evidence for Regulatory Purposes: Experience from Rare Diseases Emily Brouwer, MPH, PharmD, PhD Director Epidemiology, Department of Global Outcomes Research and Epidemiology, Data Sciences Institute, Takeda Pharmaceuticals, Boston, MA

10:25 – 10:40 am BREAK coffee and refreshments available*

10:40 am – 12:00 pm

Innovative Methods: Design and Analysis of Real-World Studies

Moderator: Michele Jonsson Funk, PhD Associate Professor, Department of Epidemiology, UNC-Chapel Hill Gillings School of Global Public Health; Director, Center for Pharmacoepidemiology, UNC-Chapel Hill Gillings School of Global Public Health

Noncompliance in Randomized Clinical Trials: A Causal Inference Perspective Michael Hudgens, PhD Professor, Department of Biostatistics, UNC-Chapel Hill Gillings School of Global Public Health; Director, Biostatistics Core of the UNC Center for AIDS Research, UNC-Chapel Hill

Enhancing Hybrid Study Designs for Comparative Effectiveness Research Jennifer L. Lund, PhD Assistant Professor, Department of Epidemiology, UNC-Chapel Hill Gillings School of Global Public Health

TUESDAY, MAY 7

10:40 am – 12:00 pm cont.

Disease Risk Scores and Their Use in Single-Arm Studies When Contemporary Active Comparators May Not be Feasible

Richie Wyss, PhD Instructor in Medicine, Harvard Medical School; Associate Epidemiologist, Division of Pharmacoepidemiology and Pharmacoeconomics, Brigham and Women’s Hospital, Boston, MA

12:00 — 1:00 pm LUNCH BREAK boxed lunches and refreshments served*

1:00 — 2:00 pm

KEYNOTE ADDRESS: FDA’s Framework For Real-World Evidence – Charting a Course for Regulatory Use

Jacqueline Corrigan-Curay, JD, MD Director, Office of Medical Policy, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, MD

2:00 — 2:30 pm

CER in the Triangle: Presentation of Accepted Abstracts

Dipeptidyl Peptidase-4 Inhibitors and Risk of Inflammatory Bowel Disease: Real-World Evidence in U.S. AdultsTiansheng Wang, PharmD Doctoral Student, Department of Epidemiology, UNC-Chapel Hill Gillings School of Public Health

Residual Confounding and Treatment Effect Heterogeneity: An Applied ExampleMitchell M. Conover, PhD Post-Doctoral Fellow, Department of Epidemiology, UNC-Chapel Hill Gillings School of Global Public Health

2:30 — 2:45 pm BREAK coffee and refreshments available*

2:45 — 3:45 pm

MODERATED DISCUSSION: The Future of Real-World Evidence: Promising Possibilities and Perils Ahead

Moderator: Lisa LaVange, PhD Professor and Associate Chair, Department of Biostatistics, UNC-Chapel Hill Gillings School of Global Public Health; Director, Collaborative Studies Coordinating Center, UNC-Chapel Hill Gillings School of Global Public Health

John Buse, MD, PhD Verne S. Caviness Distinguished Professor, Department of Medicine, UNC School of Medicine; Chief, Division of Endocrinology; Director, NC TraCS Institute

Cindy Girman, DrPH President, CERobs Consulting, LLC, Chapel Hill, NC

Til Stürmer, MD, MPH, PhD Nancy A. Dreyer Distinguished Professor and Chair, Department of Epidemiology, UNC-Chapel Hill Gillings School of Global Public Health

Bryce Reeve, PhD Director, Center for Health Measurement; Professor of Population Health Sciences and Pediatrics, Duke University School of Medicine

3:45 — 4:00 pm CLOSING COMMENTS

* food and refreshments included with registration