Continual reassessment method for dose escalation clinical trials in oncology: a comparison of prior skeleton approaches using AZD3514 data.

ABSTRACT:

Background

The continual reassessment method (CRM) requires an underlying model of the dose-toxicity relationship ("prior skeleton") and there is limited guidance of what this should be when little is known about this association. In this manuscript the impact of applying the CRM with different prior skeleton approaches and the 3 + 3 method are compared in terms of ability to determine the true maximum tolerated dose (MTD) and number of patients allocated to sub-optimal and toxic doses.

Methods

Post-hoc dose-escalation analyses on real-life clinical trial data on an early oncology compound (AZD3514), using the 3 + 3 method and CRM using six different prior skeleton approaches.

Results

All methods correctly identified the true MTD. The 3 + 3 method allocated six patien

SUBMITTER: James GD 

PROVIDER: S-EPMC5007718 | biostudies-literature | 2016 Aug

REPOSITORIES: biostudies-literature