Real-world data (RWD) is becoming an essential foundation for building credible external control arms (ECAs), particularly in rare disease research where randomized controlled trials are often less feasible. RWD offers unique advantages; it reflects real clinical practice, captures diverse patient populations, and can provide data for robust treatment effects.

However, integrating data from multiple sources, such as patient registries, concurrent trials, historical trials, and cross-population datasets, requires careful methodological planning to ensure validity and regulatory acceptance.

This webinar will explore strategies for selecting, combining, and analyzing diverse data sources to create fit-for-purpose ECAs.

Key Topics

• How standard ECA designs and advanced methods, including Bayesian borrowing, can be applied effectively while potential biases are identified and mitigated
• Practical guidance on regulatory, health technology assessment (HTA), and payer considerations
• Real-world case studies demonstrating successful implementation of diverse data sources and analytical approaches, with lessons learned and best practices

Speakers

Deepa Jahagirdar, Associate Research Principal

Vartika Savarna, Research Consultant