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 4 — How Real-World Evidence and Predictive Modeling Support OS-Focused Trial Designs
Combining RWE and predictive modeling allows sponsors to strengthen OS-focused clinical trial designs, improve forecasting, and enhance regulatory confidence. In this segment, Ananth explains how these tools bridge data gaps and drive smarter oncology drug development.
Published: 2025 年 9 月 25 日
More from this series
真实世界证据解决方案
真实世界证据（RWE）弥合了临床试验与实际患者疗效之间的差距。Certara’s Real-World Evidence Services provide robust solutions across the entire product lifecycle, ensuring your strategies are data-driven and scientifically sound.
