Fit-for-purpose approach to biomarker assay deployment in medicinal product clinical trials

This discussion paper provides MedTech Europe’s perspectives on the role of predictive biomarker assays in clinical trials and applicable regulatory frameworks and practices across Europe, to achieve a harmonised understanding of how the regulatory framework of the IVD Directive should be applied. It proposes that biomarker assays used in early clinical trials may be validated using a fit-for-purpose approach. It is intended as a basis for dialogue with authorities and other stakeholders.