The Oncology Quality Characterization and Assessment of Real-World Data (QCARD) Initiative

The Food and Drug Administration (FDA) is receiving an increasing volume of real-world data (RWD) submissions for regulatory review, and much of this activity is in Oncology medical product development. The Oncology QCARD initiative is a collaboration between the FDA Foundation and the FDA Oncology Center of Excellence (OCE) aimed enhancing the characterization of Oncology RWD regulatory submissions to facilitate effective communication with Sponsors. The initiative is engaging with external subject matter experts to evaluate key data characteristics that can encourage more efficient review of RWD study designs across oncology research objectives.



  1. Review the current published literature, guidelines, and guidances on RWD quality and dimensions of quality measurement to inform knowledge, identify gaps, and build on previous conceptual models.
  2. Define key study and data elements necessary to guide fit-for-purpose RWD assessment in the context of oncology-specific research objectives.
  3. Engage stakeholders to obtain feedback on essential study design elements and data characteristics to facilitate efficient RWD characterization.



This project is supported by the Food and Drug Administration (FDA) of the U.S. Department of Health and Human Services (HHS) as part of an award of $246,269 in federal funds (100% of the project). The contents are those of the author(s) and do not necessarily represent the official views of, nor an endorsement, by FDA, HHS, or the U.S. Government. For more information, please visit