Adaptive design for identifying maximum tolerated dose early to accelerate dose-finding trial.

ABSTRACT:

Purpose

The early identification of maximum tolerated dose (MTD) in phase I trial leads to faster progression to a phase II trial or an expansion cohort to confirm efficacy.

Methods

We propose a novel adaptive design for identifying MTD early to accelerate dose-finding trials. The early identification of MTD is determined adaptively by dose-retainment probability using a trial data via Bayesian analysis. We applied the early identification design to an actual trial. A simulation study evaluates the performance of the early identification design.

Results

In the actual study, we confirmed the MTD could be early identified and the study period was shortened. In the simulation study, the percentage of the correct MTD selection in the early identification Keyboard and earl

SUBMITTER: Kojima M 

PROVIDER: S-EPMC8985324 | biostudies-literature | 2022 Apr

REPOSITORIES: biostudies-literature