From Two Trials to One: Maximizing the Opportunity With Real-World Data

Speaker(s): Johnathan Lancster, MD, PhD & Esther Kim, PhD

The FDA’s acceptance of single pivotal trial pathways is reshaping how therapies reach patients, creating new opportunities to accelerate development while managing cost and risk.

To succeed in this new one-trial paradigm, organizations must rethink how trials are designed and how evidence is generated. Real-world data is emerging as a critical enabler, informing smarter trial design, supporting external comparators, and extending evidence beyond traditional trial endpoints. In this webinar, we will explore how these approaches can be applied across the clinical lifecycle, including feasibility, enrollment, and post-market follow-up, along with key regulatory use cases. Join us to learn how leading organizations are modernizing clinical development to move faster, make more confident decisions, and deliver therapies to improve patient lives sooner.

Topics:

• Improve trial design and enrollment with real-world data
• Support single-arm trials and regulatory submissions
• Generate longitudinal evidence for safety and effectiveness