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, produced by Applied Clinical Trials (ACT), Ananth Kadambi, VP of Real-World Evidence and Modeling Solutions at Certara, shares insights on how the 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 1 — Operational Challenges of Using Overall Survival as a Primary Endpoint
Longer timelines, higher costs, and complex patient retention strategies make OS a demanding endpoint for sponsors. In this interview, Ananth Kadambi discusses how data integration, smarter design, and operational excellence can help overcome these challenges.
Published: 2025 年 9 月 22 日
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