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


The FDA definition for non-interventional studies is intuitively actionable. We, as researchers, can (confidently) classify our study based on the parameters provided, which in turn allows us to identify the applicable regulations and guidelines and build our study playbook to describe what we need to do (regulatory requirements) and what we should consider (regulatory considerations) depending on the intended use of the RWE we generate.

4 MARCH 2024 – 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.

Read the full article HERE.