For years, industry stakeholders have been hoping for a clearer definition of non-interventional studies (NIS), which observe patients treated under real-life conditions to obtain information on a drug’s safety and effectiveness. NIS are the “untamed beast,” and each must be approached carefully in order to identify the complex regulatory and operational requirements that pertain to each European country.
Unfortunately, sometimes an attempt at clarity begets complexity. Such is the consequence of the new European Clinical Trials Regulation (EU CTR) EU Regulation No 536/2014, which was adopted in April 2014 and will become applicable no earlier than May 28, 2016. (#_ftn1) The EU CTR defines a low-interventional clinical trial—a new middle ground between the clinical trial and NIS—that, in practice, further complicates sponsors’ job of untangling requirements and making sense of country-level interpretations.
Here, we review the various definitions of NIS, explore the aspects of those definitions left open to interpretation, and offer recommendations to sponsors for dealing with the ambiguity.