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Hosted Session/Non-CE: Case Study Hosted by Truveta: From Two Trials to One: Maximizing the Opportunity with Real-World Data in the Evolving Regulatory Landscape
Session Chair(s)
Session Chair Invited
, United States
The FDA's acceptance of single pivotal trial pathways is creating new opportunities to accelerate drug development while managing cost and risk. Success in this one-trial paradigm requires a new approach to trial design and evidence generation. Real-world data are helping organizations optimize study design, support external comparators, improve enrollment, and extend evidence generation beyond traditional trial endpoints. In this session, we'll explore how real-world data can be applied across the clinical development lifecycle, from feasibility and enrollment through post-market evidence generation, including key regulatory use cases. Attendees will gain practical insights into how leading organizations are modernizing development programs to make faster, more confident decisions and bring therapies to patients sooner.
Learning Objective : - Assess the impact of FDA’s evolving single pivotal trial framework and regulatory uses of real-world data to support approvals, label expansions, and post-market commitments
- Evaluate opportunities to leverage real-world data and evidence across the clinical development lifecycle to improve decision-making and operational efficiency
- Gain actionable insights for building a modern evidence-generation strategy that extends beyond the clinical trial
Speaker(s)
Conor Wyand
Vice President, Partnerships, Truveta, United States