In early development, time and patient availability are often limited and traditional randomized controlled trials (RCTs) aren’t always feasible or sufficient. Small populations, ethical considerations, and the pressing need to deliver therapies faster make it increasingly difficult to generate the comparative evidence required for confident decision-making.

External control arms (ECAs) offer a powerful alternative to traditional trial designs. By leveraging data from single-arm studies, post-market evidence, and real-world sources, ECAs enable smaller, more efficient trials without the need for a concurrent control group.

The result? Agile, cost-effective, and patient-centric designs that accelerate timelines and reduce patient burden, while maintaining scientific and regulatory rigor.

Join us for this insightful webinar to learn when and why ECAs make sense, how to evaluate and integrate the right data sources, and the strategies that ensure credibility and regulatory acceptance

Key Topics

• When ECAs add value in early development
• How to identify and assess data sources — from literature and clinical trials to real-world data
• Strategies to ensure credibility and regulatory acceptance while keeping patient needs at the center

Speakers