Real World Evidence Conference

In recent years, regulators around the world encourage the industry to explore different ways to enhance the use of RWE for demonstrating effectiveness in regulatory submissions. Adopting pragmatism into Randomized Clinical Trial (RCT) design is considered a highly promising strategy of utilizing RWE in regulatory decision-making. The recent COVID-19 pandemic has drawn increased attention to novel approaches for generating evidence and will expand our understanding of the role of novel RWE trial designs. In this session, speakers and panelists from regulatory agencies, industry, and academia will discuss the design, implementation, regulatory acceptance, opportunities and challenges of novel RWE trial designs from policy, methodological, operational, and technical perspectives. Real-case studies (Registry-based Randomized Clinical Trial) that have been accepted by multiple Health Authorities will be shared.