Collection and analysis of real-world data (RWD) continue to gain traction in the biomedical community, accompanied by a growing understanding of RWD’s strengths and limitations. Increased collection of RWD is leading to the generation of real-world evidence (RWE) that can potentially inform regulatory decisions regarding the safety and effectiveness of medical therapies. Such regulatory decisions include whether to approve the drug, what the drug’s indication(s) should be, and what safety protocols (if any) are necessary to ensure safe use of the product.
