What’s in a name? Clarifying clinical research terms in the new FDA-NIH glossary

Stuart McCully (Real-World Research Ltd) delves into the nuances of the newly-announced FDA and National Institutes of Health (NIH) draft glossary aimed at establishing consistency in clinical and real-world evidence (RWE) research terminology. And so it begins... The FDA and the National Institutes of Health (NIH) have developed a draft glossary, open for public comment, to clarify clinical research terms related to innovative study designs, including those using real-world data (RWD) to generate real-world evidence (RWE). The glossary aims to establish a common vocabulary to uniformly characterize clinical research, including studies using RWD to generate RWE. By doing so, it...