Real-world data have an increasingly important role in clinical development and regulatory decision-making. When incorporated correctly, they can provide a unique and valuable insight into patient populations, treatment patterns, and health outcomes in support to the traditional clinical development. To that end, transparency in reporting, including clear documentation of study populations, data sources, statistical methods, and limitations, is critical, particularly when seeking regulatory acceptance. Recognised standards of reporting should be considered as they can help to enhances reproducibility and regulatory acceptance.

Medical Writing. 2025;34(3):48–53. https://doi.org/10.56012/kygt4232