May 7, 2019, 8:00am-4:00pm
RTI International, Horizon Building Auditorium
Research Triangle Park, NC (Free Parking)

Real-World Evidence for Regulatory Decision-Making, hosted by NC TraCS, brought together speakers from academia, industry, and federal agencies to discuss challenges, opportunities, analytic considerations, and future directions regarding the use of real-world evidence in health research and regulation.

Triangle Research Symposium 2019

May 7, 2019, 8:00am-4:00pm
RTI International, Horizon Building Auditorium
Research Triangle Park, NC (Free Parking)

Real-World Evidence for Regulatory Decision-Making, hosted by NC TraCS, brought together speakers from academia, industry, and federal agencies to discuss challenges, opportunities, analytic considerations, and future directions regarding the use of real-world evidence in health research and regulation.

Program

The Keynote address was given by Dr. Jacqueline Corrigan-Curay, JD, MD, Director, Office of Medical Policy at the FDA's Center for Drug Evaluation and Research. Dr. Corrigan-Curay leads the development, coordination, and implementation of multiple medical policy programs and strategic initiatives, including the FDA's framework on real-world evidence.

Download the program (pdf)


View presentations from the symposium

Presentation Speaker
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
Multi-Database Study Accepted by FDA in Place of a Cardiovascular Outcomes Trial in Drug Approval: Case Study of Prucalopride Elizabeth 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
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
Use of Risk Scores for Confounding Adjustment in Early Post-Market Surveillance Richie Wyss, PhD Instructor in Medicine, Harvard Medical School; Associate Epidemiologist, Division of Pharmacoepidemiology and Pharmacoeconomics, Brigham and Women's Hospital, Boston, MA
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
Dipeptidyl Peptidase-4 Inhibitors and Risk of Inflammatory Bowel Disease: Real-World Evidence in U.S. Adults Tiansheng Wang, PharmD Doctoral Student, Department of Epidemiology, UNC-Chapel Hill Gillings School of Public Health
Residual Confounding and Treatment Effect Heterogeneity: An Applied Example Mitchell M. Conover, PhD Post-Doctoral Fellow, Department of Epidemiology, UNC-Chapel Hill Gillings School of Global Public Health
Moderated Discussion Moderated by Lisa LaVange
Panelists: John Buse, Cindy Girman, Til Stürmer, and Bryce Reeve
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