Practical implementation of the partial ordering continual reassessment method in a Phase I combination-schedule dose-finding trial.

ABSTRACT: There is a growing medical interest in combining several agents and optimizing their dosing schedules in a single trial in order to optimize the treatment for patients. Evaluating at doses of several drugs and their scheduling in a single Phase I trial simultaneously possess a number of statistical challenges, and specialized methods to tackle these have been proposed in the literature. However, the uptake of these methods is slow and implementation examples of such advanced methods are still sparse to date. In this work, we share our experience of proposing a model-based partial ordering continual reassessment method (POCRM) design for three-dimensional dose-finding in an oncology trial. In the trial, doses of two agents and the dosing schedule of one of them can be escalated/de-escalated

SUBMITTER: Mozgunov P 

PROVIDER: S-EPMC10100035 | biostudies-literature | 2022 Dec

REPOSITORIES: biostudies-literature