Public Workshop: Oncology Clinical Trials in the Presence of Non-Proportional Hazards

Convened by the Duke-Robert J. Margolis, MD, Center for Health Policy at Duke University and supported by a cooperative agreement with FDA, this public event will bring together multi-disciplinary experts to explore and discuss approaches for addressing key challenges related to the evaluations of cancer products in the presence of non-proportional hazards. Discussion will encompass the development and application of innovative oncology clinical trial designs, alternative statistical methods for evaluating treatment effects of time-to-event endpoints, and potential outcome measures that more accurately capture treatment effect.

The development of novel cancer therapeutics is a growing field, with the potential to transform care for patients. However, there are ongoing challenges with oncology clinical trial designs and analysis of treatment effects for cancer therapies that may impact our understanding of investigational drugs.