Data and Real-World Evidence

For decades, researchers have utilized data from electronic medical records, insurance claims, registries and more to answer questions about how their product is performing in the real world. Traditionally, these real-world data (RWD) have been used to monitor post-market safety and adverse events for regulatory decision making.

However, over the past several years, the number of health care datasets and novel data sources have increased exponentially, providing researchers faster and more accurate insight into their products. With the increasing cost of health care and access to more data than ever before, payers and health authorities have increased their expectations, demanding more and better evidence of a product’s value, safety and effectiveness.