The National Institutes of Health (NIH) and the U.S. Food and Drug Administration (FDA) have released for public comment a draft glossary of clinical research terms related to innovative clinical trial design, including studies using real world data to generate real world evidence. The draft glossary is intended to facilitate communication within the clinical research community by helping establish a common vocabulary to characterize clinical research more uniformly.

The draft glossary and information on how to provide comments can be viewed here. NIH and FDA will accept comments on the draft glossary until June 24, 2024.

For additional context on this NIH-FDA collaboration, please see the latest Under the Poliscope blog by Dr. Lyric Jorgenson.

Questions about this draft glossary can be sent to SciencePolicy@od.nih.gov

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