Analysis of the profiles of treated patients, dosage, treatment duration, compliance, discontinuing or switching treatment and all that is pharmaco-epidemiology related...data that provides information about how medicines and healthcare products are used in real-life. These studies have become essential for both companies and health authorities, as well as patients themselves and all those involved in the health sector.
So it is the case that as controlled randomized trials remain the benchmark methodology for obtaining an MAA, health authorities and paying authorities now request that this information be supplemented with real-life data and post-MAA studies for a better understanding of how healthcare products are actually used throughout life.
Proper usage, the detection of clinical signs or incorrect usage, side effects, identifying therapeutic schemas, producing analyses of sub-groups of patients....products insights based on the processing of “real-life” data are considerable both for research as well as for health authorities or economic players. Data analysis can support strategic decisions in public health or even in the context of controlling health expenditure, enhancing innovation and inspiring new products and services.