Adaptive designs for clinical trials assessing biomarker-guided treatment strategies.

ABSTRACT:

Background

The Biomarker Strategy Design has been proposed for trials assessing the value of a biomarker in guiding treatment in oncology. In such trials, patients are randomised to either receive the standard chemotherapy treatment or a biomarker-directed treatment arm, in which biomarker status is used to guide treatment.

Methods

Motivated by a current trial, we consider an adaptive design in which two biomarkers are assessed. The trial is conducted in two stages. In the first stage, patients in the biomarker-guided arm are assessed using a standard and an alternative cheaper biomarker, with the standard biomarker guiding treatment. An analysis comparing biomarker results is then used to choose the biomarker to use for the remainder of the trial. The new biomarker is used

SUBMITTER: Wason J 

PROVIDER: S-EPMC3992506 | biostudies-literature | 2014 Apr

REPOSITORIES: biostudies-literature