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), Ananth explores how sponsors can meet OS expectations while keeping oncology trials efficient, innovative, and patient-centered.
Part 2 — How FDA’s Focus on Overall Survival Redefines Trial Success
The FDA’s growing emphasis on OS as the primary endpoint is reshaping how sponsors define success. Ananth Kadambi explains how efficacy, safety, payer access, and patient outcomes must now work in harmony for true clinical impact.
Published: 2025 年 9 月 23 日
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