How Can We Optimally Incorporate Real World Evidence into Regulatory Decision Making?
Jeffrey N. Stuart, PhD, RAC
Global Regulatory Director, Oncology, Immunology, and InVitro Diagnostics
Merck & Co., Inc., United States
Why has the utilization of real-world data to assess efficacy lagged relative to the application of real-world safety data? Important questions must be addressed concerning efficacy data quality, endpoint surrogacy, and overall study design. This session will bring together global regulators, healthcare technologists, and drug developers to tackle the practical challenges, so that real world evidence can be more optimally incorporated into regulatory decision making.
Learning Objective : Explore how real-world data must be collected, analyzed and reported in order to be useful in regulatory decision-making beyond the post-market safety surveillance setting.
European Medicines Agency (EMA), United Kingdom
Nikolai Constantin Brun, MD, PhD
Chief Medical Officer, Director of Division for Medical Evaluation and Biostats
Danish Medicines Agency , Denmark
Jeff Allen, PhD
President and Chief Executive Officer
Friends of Cancer Research, United States
Jacqueline A. Corrigan-Curay, JD, MD
Director, Office of Medical Policy, CDER
FDA , United States