Reviewing the evidence supporting predictive biomarkers in European medicines agency indications and contraindications using visual plots

Objectives Predictive biomarkers can be used to identify most suitable treatments for patients. To maximise patient benefit valid predictive biomarkers need to be used and several trial designs have been proposed to achieve this. We aimed to review the evidence considered sufficient by the European Medicines Agency (EMA) for inclusion of a predictive biomarker in a drug indication or contraindication and this required development of a methodology to summarise key information.