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 regulatory expectations while keeping oncology trials efficient, innovative, and patient-centered.
Part 5 — Preparing for the Operational Burden of OS Requirements in Oncology Trials
Meeting requirements to track OS as the primary study endpoint means longer follow-up periods, complex patient monitoring, and greater operational burden. Ananth Kadambi discusses how clinical operations teams can plan for these demands through proactive patient tracking, early data monitoring committee engagement, and robust subgroup analysis.
Published: 2025 年 9 月 26 日
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