Early-phase oncology combination trials often assume the optimal dose is already included in the dosing grid. When it isn’t, sponsors may face subtherapeutic or overly toxic recommendations, protocol amendments, and delays.
This white paper explores a contour-based method for inserting new dose combinations mid-trial, helping improve dose selection while maintaining safety and regulatory transparency.
What You’ll Learn
- How structured mid-trial dose insertions work
- Simulation results demonstrating improved dose selection
- Practical considerations for early-phase oncology studies
- How flexible dose-finding supports modern dose optimization strategies
About the Author
Matt George, Senior Statistician, Phastar
Specialist in early-phase oncology trial design and co-author of the Statistics in Medicine publication introducing this contour-based dose insertion method.
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