Progression Free Survival Or Overall Survival? Reconciling An Old Debate With Modern Technology

By Esha Senchaudhuri

A key decision in the design of clinical trials in oncology involves whether to select progression free survival (PFS) or overall survival (OS) as the primary endpoint of a clinical trial. Both are important to patients and clinicians, yet their impact on various features of a sponsor's clinical development and market access strategy move beyond the rudiments of traditional trial design. Indeed the evaluation of tradeoffs when choosing from these endpoints requires careful consideration and expertise to channel statistical strategy towards financial success and industry advantage.

Most sponsors use PFS when trying to secure regulatory approval,  and OS for market approval and market access. Building clinical trial designs that optimize across both has historically proven challenging, but new technology like Cytel's Solara has also paved the way for new methods to find these potent designs.