Adaptive dose-finding studies: a review of model-guided phase I clinical trials.

ABSTRACT:

Purpose

We provide a comprehensive review of adaptive phase I clinical trials in oncology that used a statistical model to guide dose escalation to identify the maximum-tolerated dose (MTD). We describe the clinical setting, practical implications, and safety of such applications, with the aim of understanding how these designs work in practice.

Methods

We identified 53 phase I trials published between January 2003 and September 2013 that used the continual reassessment method (CRM), CRM using escalation with overdose control, or time-to-event CRM for late-onset toxicities. Study characteristics, design parameters, dose-limiting toxicity (DLT) definition, DLT rate, patient-dose allocation, overdose, underdose, sample size, and trial duration were abstracted from each study.

SUBMITTER: Iasonos A 

PROVIDER: S-EPMC4121508 | biostudies-literature | 2014 Aug

REPOSITORIES: biostudies-literature