論文: Applied Clinical Trials
As the FDA increasingly emphasizes overall survival (OS) as the gold-standard endpoint in oncology drug trials, sponsors face mounting scientific and operational challenges.
In this five-part video series by Applied Clinical Trials (ACT), Ananth Kadambi, VP of Real-World Evidence and Modeling Solutions at Certara, shares insights on how the pharmaceutical industry can adapt.
Through discussions on regulatory focus, trial operations, model-informed drug development (MIDD), and real-world evidence (RWE), Dr. Kadambi explores how sponsors can meet OS expectations while keeping oncology trials efficient, innovative, and patient-centered.
Part 3 — Using Model-Informed Drug Development to Support OS Endpoints
Model-informed drug development (MIDD) helps sponsors predict efficacy, assess safety, and align shorter oncology trials with long-term OS expectations. Ananth also highlights how modeling and simulation is becoming indispensable to regulatory strategy.
公開: 2025年9月24日
More from this series
Real-World Evidence Solutions
Real-world evidence (RWE) bridges the gap between clinical trials and actual patient outcomes. Certara’s Real-World Evidence Services provide robust solutions across the entire product lifecycle, ensuring your strategies are data-driven and scientifically sound.
