|
Abstract:
|
Phase I/II trials generate valuable information when a new drug is applied to human subjects for the first time. One of their primary objectives is to identify a dose such that it is both well tolerated and potentially effective, which is then recommended for subsequent clinical trials. Thus, it is critical to the success of the entire development program to find the dose that achieves the optimal balance of safety and efficacy. This, however, is challenging because the data available in early phase oncology trials is often limited. We will start our discussion by a brief review of popular methods currently implemented in Phase I oncology trials to find the maximum tolerated dose. Then we will focus our discussion on dose-finding methods that consider both toxicity and efficacy. In addition, we will discuss dose-finding methods for the combination of multiple therapies. We will conclude our discussion by touching on the recent trend in the development of dose-finding methods in oncology trials.
|
