A new guidance from the U.S. Food and Drug Administration (FDA) is intended to help sponsors and other stakeholders designing a registry or using an existing registry with real-world evidence (RWE) and/or real-world data (RWD) to support regulatory decision-making about a drug’s effectiveness or safety.
FDA defines RWD as “data relating to patient health status and/or the delivery of healthcare routinely collected from a variety of sources.”
FDA says RWE is “the clinical evidence about the usage and the potential benefits or risks of a medical product derived from analysis of RWD.”
In the guidance, FDA offers its perspectives on:
- Considerations regarding a registry’s fitness-for-use in regulatory decision-making, focusing on attributes of a registry that support the collection of relevant and reliable data.
- Considerations when linking a registry to another data source for supplemental information, such as data from medical claims, electronic health records, digital health technologies, or other registries.
- Considerations for supporting FDA review of submissions that include registry data.
Edited by Michael Causey
