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Clinical trials for rare diseases are reaching a critical inflection point as traditional designs struggle to meet the demands for speed, efficiency, and patient access. External Control Arms (ECAs) are rapidly gaining traction as sponsors look for credible ways to leverage real-world data and optimize evidence generation. Yet, questions remain: What does it really take for an ECA to gain regulatory acceptance?
This webinar will explore how agencies such as the FDA, EMA, and MHRA are shaping expectations for using ECAs for rare diseases and what sponsors must demonstrate to meet those standards. Our experts will share insights from recent regulatory approvals, outline practical prerequisites for success, and offer guidance on integrating ECAs into ongoing and future programs. Join us to understand where the regulatory bar is moving, what constitutes credible evidence, and how to position your development strategy for the next era of clinical trials in rare diseases.
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