Real-World Data, Big Data, and Artificial Intelligence

Real-world evidence (RWE) is increasingly gaining importance in the regulatory framework of the European Union (EU). The evidence generated can be used for advancing care through end-to-end applications across the entire product cycle. Furthermore, it can help better understand the impact of various diseases on vulnerable populations, in addition to facilitating development of tailored telemedicine and care plans. Thus, integrating RWE into healthcare becomes essential for the next generation of research and development, especially in regulatory settings. The Heads of Medicines Agencies (HMA) and European Medicines Agencies (EMA) recently held several workshops, focusing on big data and artificial intelligence as key initiatives. The EMA has issued a number of guidance documents for leveraging real-world data (RWD) in the areas of medical evidence generation and regulatory approval. In this chapter, the EMA’s Network Strategy to 2025, RWD, big data, data quality, data privacy protection, ethics and informed consent are briefly summarized.