論文: Applied Clinical Trials
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.
公開: 2025年9月25日
More from this series
リアルワールドエビデンス創出ソリューション
リアルワールドエビデンス（RWE）は、臨床試験と実臨床における患者アウトカムをつなぐ役割を果たします。Certara’s Real-World Evidence Services provide robust solutions across the entire product lifecycle, ensuring your strategies are data-driven and scientifically sound.
