Leader:
Mario Negri Institute for Pharmacological Research (IRFMN)
Objectives:
WP2 aims to perform a scoping review of the scientific literature and position papers in order to provide an 'inventory' of the available relevant literature, and to describe the methodological practices in the various steps of personalised medicine programmes. This will help to identify needs and gaps in terms of standardised methodology and data generation, management, analysis, and interpretation. The scoping review will cover in particular:
- Stratification and validation cohorts
- Machine learning stratification methods
- Methods used to assign treatment options to patient clusters
- Randomised trials in personalised medicine
Description of work:
Numerous guidelines have been developed for interventional trials, concerning protocol design (SPIRIT statement), study management, quality and reliability of data (ICH-GCP, EU 2001/20/EC Directive, EU 2014/536 Regulation), and planning and conduct of statistical analyses.
However, standard methodologies are lacking for personalised medicine research programmes. In addition, the definition of personalised medicine and research on personalised medicine is still ambiguous.
WP2 will reach consensus on a common operational definition of personalised medicine research to drive the selection of scientific articles for the scoping review. This review will identify the gaps in methodological guidelines for each phase of personalised medicine research, and it will set the foundation for work packages 3 to 6.