| 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 |
