The PERMIT project will begin by mapping the scientific literature, regulatory frameworks and position papers on the various steps of personalised medicine programmes (WP2 literature mapping and gap analysis). This will lead to the identification of needs in terms of standardised methodology and data generation, management, analysis and interpretation.
Building on this gap analysis, work packages 3 to 6 will explore specific stages of personalised medicine research programmes. WP3 will address the design of stratification and validation cohorts, including issues related to statistical power, quality of data for stratification studies, requirements for data protection and informed consent (in case of reuse of retrospective data), data monitoring, traceability, and multimodal data management tools.
WP4 will focus on the application and types (supervised or unsupervised) of different stratification algorithms, and the robustness and validation of the stratification methods.
WP5 will be dedicated to translational research establishing a link between data-driven stratification and the choice of treatment options (based on the mechanism of drug action, and selection of treatments to be tested in each of the subgroups).
WP6 will be dedicated to randomised clinical trials needed to test treatment strategies for each of the identified patient clusters, and to test the added value of the personalised approach vs. non-personalised standard of care.
Each WP will strive to produce recommendations and publications in scientific journals, which will be disseminated at a final meeting and through webinars to foster adoption and facilitate implementation (see WP7 dissemination and implementation).