The FDA’s Project Optimus has fundamentally changed how sponsors select doses in oncology, moving from the Maximum Tolerated Dose to the Optimal Biological Dose. Statistical designs have advanced quickly, although their impact and applicability in achieving the ultimate goals of dose optimization remain unclear. In practice, the operational reality has not yet caught up, leaving dose decisions reliant on spreadsheets, lagging data exports, and ad hoc reconciliation across systems.
This webinar walked through a modern dose-finding toolkit from BOIN to efficacy-toxicity designs to seamless Phase I/II and demonstrate how eClinical technology can support adaptive oncology trials in practice.
WATCH THE WEBINAR RECORDING
Key learnings:
- Understand the shift in oncology dose selection: why Project Optimus is moving the field from maximum tolerated dose toward optimal biological dose.
- Get oriented in the modern dose-finding toolkit: including BOIN, efficacy-toxicity designs, and seamless Phase I/II approaches.
- Recognize the practical implementation gap: how dose decisions can still be slowed by spreadsheets, delayed data exports, and manual reconciliation across systems.
- See how adaptive oncology trials can be operationalized in practice: using a live cohort tracker that brings DLT capture, PK review, and Safety Review Committee decisions into one workflow.
- Leave with a clearer view of what is needed for effective dose optimization: combining sound statistical design with timely, integrated trial operations.
Speakers:
- Leandro Garcia Barrado, Principal Statistical Scientist, IDDI
- Manuel Neukum, CEO, AB Cube Germany
