Join Amy Mulick, Head of Evidence & Value Generation at Veramed, and Christen Gray, Director, Real World Science for Vaccines & Immune Therapies at AstraZeneca, as they share their RWD expertise and how best to approach analyses with external comparators, with insight from a Statistical perspective.
Agenda
- Why and When to use an ECA in a clinical trial
- What type of expertise is required for an ECA
- Why both clinical and observational study expertise is paramount
- Important considerations when using ECAs
- Managing concerns from regulatory bodies
- Criteria checklist for control selection
- Choosing the right source of real-world data
- Other design factors for ECAs to ensure minimal bias
