“Beyond 3+3: Rethinking Early-Phase Oncology Study Design”
📅 Friday, October 10, 2025 | 10am EDT (NA) / 3pm BST (UK) / 4pm CEST (EU-Central)
Early-phase oncology trials are undergoing a fundamental shift in study design. Traditional 3+3 dose escalation methods, which have long been the standard for first-in-human cancer studies, are increasingly being replaced by more statistically robust, adaptive designs. This transition is driven by the rise of targeted therapies, evolving regulatory expectations and the need to more accurately identify an optimal biological dose (OBD) rather than simply the maximum tolerated dose (MTD).
In this webinar, the featured speakers will engage in a dynamic conversation exploring both the statistical underpinnings and operational realities of model-assisted or model-based approaches to dose escalation and optimization. The discussion will highlight the drivers behind this shift, the strengths and limitations of various escalation methods and key considerations for implementing these models to balance safety, efficiency and regulatory compliance.
