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Optimising effectiveness in patients of existing prescription drugs for major diseases (except cancer) with the use of biomarkers

 

The applicants should perform the clinical validation of qualified biomarkers (not limited to molecular biomarkers) that will enable the identification of appropriate patients to ensure an effective and efficient use of existing pharmaceuticals in the treatment of major diseases and conditions. The relevant biomarkers should allow providing the right medicinal product, at the right dose and the right time, according to the concept of personalised medicine, taking into account, among others, differences of sex, age, ethnicity and gender identity. This topic refers to medicines that are already on the market and not to the validation of biomarkers for the development of new medicinal products. It addresses broadly prescribed medicines for major diseases and conditions, including but not limited to cardiovascular diseases. A condition is that preliminary studies or publications have demonstrated that the pharmaceuticals considered are efficient in less than 50% of the population treated. This topic excludes cancer and rare disease treatments. The applicants should consider existing guidelines, standards and regulations, as appropriate. Synergies with relevant European Research Infrastructures are encouraged.