Real World Data (RWD) is defined as data collected outside of the context of conventional randomized controlled trials (RCTs) and the generated evidence obtained through the synthesis and analysis of these RWD is defined as real-world evidence (RWE) and may affect healthcare decision making by filling evidence gaps for regulatory decisions along a medicine’s lifecycle.
The long lasting ‘hype’ for Digital Health, has recently intersected with the ‘real world data generation’ and is providing important insights into how patients and practitioners are managing their healthcare, using healthcare products and services, including utilizing digital health technologies. Thus, the pharmaceutical industry, regulators, and health technology assessment bodies are increasingly exploring the potential of real-world data (RWD) generated by innovative digital health devices as a complementary source to generate evidence regarding the effectiveness and safety of medicines in routine clinical practice.
