A gap in our understanding
Randomized clinical trials are the trusted standard and a crucial step in securing a medicine’s regulatory approval. However, they do not tell us everything about the safety and efficacy of a treatment in daily clinical practice. Scientists have spent years refining trial methodology, using the controlled conditions permitted by selecting a study population and environment to determine whether a medicine can yield a desired effect in patients. Once approved, it is launched into a world full of variables, and we cannot predict what influence these will have. So, how can we gain knowledge about the impact of usage of a medication outside a controlled environment in the real-world?