Rethinking Early-Phase Oncology Study Design

Early-phase oncology study design is being reshaped by the realities of modern therapeutics. As targeted agents, immuno-oncology treatments, and cell and gene therapies move into the clinic, traditional 3+3 dose escalation approaches are increasingly misaligned with today’s scientific and regulatory expectations. Identifying an optimal biological dose now requires designs that are more adaptive, data-driven, and patient-centered from the outset.

This on-demand webinar examines how model-assisted and model-based dose-finding approaches are changing the way early-phase oncology trials are planned and executed. Experts unpack the statistical foundations behind methods such as BOIN and CRM, highlighting where these approaches add precision — and where they introduce new operational and governance considerations. The discussion also addresses practical challenges, including trial logistics, real-time decision-making, and regulatory alignment, offering grounded perspectives on how to implement adaptive designs without slowing execution.

Designed for clinical development, operations, and biostatistics leaders, the session provides clear guidance on when and how to move beyond 3+3, and why early cross-functional collaboration is essential to realizing the full value of modern dose optimization strategies.