Secondary use of clinical trial data in the Italian legal framework

Autor: Aurucci, Paola
Rok vydání: 2019
DOI: 10.5281/zenodo.3297334
Popis: Thanks to the digital revolution, coupled with advances in computing power, medical research is becoming increasingly data intensive. The sources of such data include real-world data (such as electronic health records and data from patient registries) and data from social media and wearable devices as well as records pertaining to genomics, clinical trials and adverse drug reactions (ADRs) reported during both the pre- and post-authorisation phases. Advanced computational technologies that are used to analyse and link heterogeneous data sets and that extract hidden patterns, correlations and links of potential significance are categorised as big data analytics. According to the European Medicine Agency (EMA), the use of big data in medicines development and regulatory science will become a major trend in the coming years.
Databáze: OpenAIRE