ABSTRACT

A randomized clinical trial may fail because of insufficient efficacy due to a heterogeneous patient population. Molecular biomarkers may offer great opportunities for drug developers to further identify patient subpopulations and to provide precise medicines such that a subgroup of patients may be likely or not to benefit from a new drug or avoid a side effect. Designs of clinical trials assisted with biomarker information predicting drug responses have been seen in many therapeutic areas. In this section, a comprehensive review of classical clinical designs leveraging biomarker information is provided.