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, 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: September 22, 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.
