| Ron Smith |
Traditionally, the purpose of having a Phase I / Phase 2 dose-finding design in cancer clinical studies has been to find the
Maximum Tolerated Dose based solely on the toxicity of the study drug. Traditional designs, considering a Dose Limiting
Toxicity, implicitly assumes a monotonically increasing relationship between dose and response efficacy. However, for targeted
investigative drug products, few toxicity affects may arise prior to the most efficacious dose.This challenges the conventional
principle of "more is better until toxic" . Instead, the Optimal Biological Dose, which is defined as the lowest dose with the
highest rate of efficacy while safe, is a more appropriate endpoint.
In this presentation we will discuss the use of Bayesian
Optimal Interval (BOIN) algorithms in finding the Optimal Biological Dose in Phase 1 or combination Phase 1/2 clinical trials.
The review of the types of drugs that will produce low-dose high-efficacy treatment outcomes will be followed by a brief
introduction to the |