What’s in a name? The humble (confusing) non-interventional study and the anti-definition

Written by Stuart McCully (Real-World Research Ltd)

In his latest Guest Column, Stuart McCully (Real-World Research Ltd) discusses the differing definitions of non-interventional studies in Europe and the US, and the need for clarity when discussing these studies in real-world evidence (RWE) generation. The not so simple non-interventional study When you’re involved in clinical trials, definitions don’t seem that important. You have clinical trials regulations. They tell you what a clinical trial is, what you need to do and what you need to report. It can be considered simple. Yet the same cannot be said for non-interventional studies – the often considered backbone study used in RWE...

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