The FDA’s new draft guidance on Bayesian methodology signals a shift toward more flexible, data-driven clinical trial designs, enabling sponsors to use prior data and adaptive approaches to improve ...

The primary goal of the trial was to optimize radiation therapy (RT) dose among three levels (low, standard, and high), given either with placebo (P) or an investigational agent (A), for treating ...

Statistical designs for traditional phase I dose-finding trials consider dose-limiting toxicity in the first cycle of treatment. In reality, patients often go through multiple cycles of treatment and ...