Appropriately incorporating real-world evidence into regulatory decision making remains an area of active research and collaboration between drug developers and regulators. With randomized controlled trials becoming more difficult to implement due to complex diseases and rare populations, regulators are examining how real-world data can supplement evidence of a treatment's efficacy and safety.

In this webinar, Dr Chantal van Gils, Director of Epidemiology and Real-World Evidence for the NDA Advisory Board, discusses the growing role of real-world evidence in regulatory decision making.