New concepts in patient stratification

Proposals should deliver novel concepts for disease-mechanism based patient stratification to address the needs for stratified or personalised therapeutic interventions. The proposals should integrate multidimensional and longitudinal data and harness the power of -omics, including pharmacogenomics, systems biomedicine approaches, network analysis and of computational modelling. The new concepts of stratification should be validated in pre-clinical and clinical studies taking into account sex and gender differences. Applicants are encouraged to actively involve patient associations. The proposals should consider regulatory aspects of clinical practice and commercialisation opportunities. Proposals should focus on complex diseases having high prevalence and high economic impact.

The Commission considers that proposals requesting a contribution from the EU of between EUR 4 and 6 million would allow this specific challenge to be addressed appropriately. Nonetheless, this does not preclude submission and selection of proposals requesting other amounts.

Despite the major advances in understanding disease in the post-genomic era, still a majority of all drugs are effective in only a limited number of patients. From a clinical perspective, implementing knowledge-based decisions on what therapeutics to use for which patients and, if relevant, in which combinations, are extremely challenging. The aspiration to provide more effective therapeutic interventions tailored to the individual or groups of individuals with common molecular phenotypes remains unfulfilled because of the variable response of individuals to such interventions.

Patient stratification aims at grouping patients into disease sub-groups, where the specific pathological processes involved are better defined (clinical/molecular phenotypes). This will lead to the development of targeted therapies, optimizing the intervention to individual patients, thus achieving greater success in treating or curing the patient.

• New models for patient stratification to inform clinical decision making.
• Accelerate the translation of biomedical and clinical research results to medical use.
• Increased cost-effectiveness of the novel concepts in comparison to already established practices.
• Increased research and innovation opportunities in this innovative industries-driven field, particularly small or medium-sized enterprises (SMEs).