Identification and Confirmation of Biomarker-defined Populations in the Personalized Pharmacotherapy

Welcome to the project

The strong progress in genomic medicine increases the personalization of therapies, especially in oncology, and innovative study designs as adaptive enrichment designs, basket trials and ad hoc methods for the exploration of subgroups are established.
This project aims to identify more quickly those biomarker-based therapy approaches which are not valid or promising and may help to develop faster the very promising approaches. Different aims of the project cover on the one hand aspects on subgroup analyses and on the other hand provide an updated comprehensive classification of biomarkers with focus in oncology in order to estimate the validity of biomarker more precisely regarding clinical outcomes. Additionally, the currently accepted biomarker and the respective scientific advice approaches as well as the relevance of adequate in vitro test systems will be evaluated.

The project started in May 2016 and is supported by the Federal Institute for Drugs and Medical Devices (BfArM).