Publication: 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.
Published: September 25, 2025
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Real-World Evidence Solutions
Real-world evidence (RWE) bridges the gap between clinical trials and actual patient outcomes. Certara’s Real-World Evidence Services provide robust solutions across the entire product lifecycle, ensuring your strategies are data-driven and scientifically sound.
