9:30 Bridging the Gap Between Surrogate Endpoints & Real-World Outcomes to Strengthen Accelerated Approvals
Time: 9:30 am
day: Day 2 full
Details:
- Leverage RWE to validate surrogate endpoints by comparing them with long-term real-world outcomes, enhancing the reliability of accelerated approval processes
- Use advanced statistical models to demonstrate how surrogate endpoints can be predictive of actual patient outcomes in real-world settings
- Collaborate with regulatory agencies to align on the use of surrogate endpoints in RWE, ensuring faster access to treatments while maintaining clinical integrity
