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New MTE discussion paper: Fit-for-purpose approach to biomarker assay deployment in medicinal product clinical trials

Posted on 28.02.2019

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. The scope of this paper applies to situations where a predictive biomarker assay is used in a clinical trial context. Good study practice must be followed in all cases where there is an impact for patients, in particular the oversight by an ethics committee and all considerations due to ensure patient safety and consent.