What’s in a name? Interventional clinical trials – the assumed definition that doesn’t actually exist

In his previous Guest Column, Stuart McCully discussed non-interventional studies and their differing definitions in Europe and the US. Here Stuart mulls over the ‘interventional study’, addressing the ambiguity in what constitutes an interventional trial and how this can be overcome. The non-existent interventional clinical trial In Europe, we define clinical trials, low intervention clinical trials, and non-interventional studies [1]. Notice the obvious omission…there is no 'interventional' in front of clinical trials. For an activity to be defined as ‘low’ or ‘non’ interventional you would assume that we had already set the baseline of what is considered interventional…but we haven’t....