ABSTRACT

Real-world evidence (RWE) has long been used by regulatory agencies to monitor long-term safety and rare adverse events of marketed drug products. However, it was not until recently that stakeholders in healthcare began embracing RWE as a key driver of outcomes- and value-based strategy in the drug development life cycle. Owing to the advances in digital technologies such as cloud data storage and advanced analytics, including artificial intelligence (AI) and machine learning, real-world data (RWD), collected from disparate sources, have become more connected and effectively interrogated for insights. The new laws, regulations, and growing demand for pharmaceutical companies to demonstrate values of their products to healthcare stakeholders have given the drug developers added incentive to develop comprehensive RWE strategies and capabilities. The recent shift of the drug development paradigm toward a more personalized healthcare and value-based coverage and payment policies has further fueled the use of RWE. This chapters discuss the opportunities and challenges in transforming the way new medicines are developed, using RWD and RWE.