UC Comment Letters

This comment letter responds to the Food and Drug Administration (FDA) and National Institutes of Health (NIH)'s joint request for information on a glossary of terms related to clinical research and clinical study designs. UC asks FDA and NIH to clarify whether the proposed clinical research terminology glossary applies only to FDA-regulated studies using real-world data for medical products, or more broadly to other clinical research and observational studies. If the glossary is intended to apply broadly, UC recommends revising certain observational-study definitions and adding definitions for real-world data and real-world evidence so the glossary can serve as a clearer one-stop reference for clinical research terminology.