Run-in phase III trial design with pharmacodynamics predictive biomarkers.

ABSTRACT:

Background

Developments in biotechnology have stimulated the use of predictive biomarkers to identify patients who are likely to benefit from a targeted therapy. Several randomized phase III designs have been introduced for development of a targeted therapy using a diagnostic test. Most such designs require biomarkers measured before treatment. In many cases, it has been very difficult to identify such biomarkers. Promising candidate biomarkers can sometimes be effectively measured after a short run-in period on the new treatment.

Methods

We introduce a new design for phase III trials with a candidate predictive pharmacodynamic biomarker measured after a short run-in period. Depending on the therapy and the biomarker performance, the trial would either randomize all patients

SUBMITTER: Hong F 

PROVIDER: S-EPMC3888165 | biostudies-literature | 2013 Nov

REPOSITORIES: biostudies-literature