Publication: 应用临床试验
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.
Published: 2025 年 9 月 24 日
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