An external control arm (ECA) uses a data source external to the clinical trial, often a real-world data (RWD) cohort, to generate a comparator arm, or to enhance a comparator arm for a clinical trial. ECAs are useful when a fully powered randomized controlled comparator arm is not feasible or unethical. The acceptability of ECAs can differ between regulatory and health technology assessment (HTA) bodies, and guidelines in this area are rapidly evolving. As part of this webinar, Helene Karcher will provide an introduction into what ECAs in the context of Phase 3 programs including an overview of the key challenges when a traditional comparator arm in a randomized control trial is not feasible. Emma Hawe will provide a description of the terminology, and an overview of the key considerations, methodology, and limitations. The webinar will also provide an overview of regulatory and HTA body guidelines and provide an overview of recent acceptability of ECAs. The last 10 minutes will provide the attendees with the opportunity to ask the speakers questions regarding the use of ECAs. This webinar will be of interest to researchers, regulators, payers, and leaders participating in Phase 3 program design and new pharmaceutical product decisions interested in gaining an understanding of ECAs.
