Device manufacturers have multiple choices when it comes to post-market clinical follow-up (PMCF) activities. Two such choices are ‘patient registries’ and ‘investigator-initiated trials’, but what’s the difference? Both sound like large-scale studies after all.
Registries– The root word here is ‘register’. Registries are meant for recording or registering data. In a registry, there is no question of ‘what intervention is to be performed?’. A registry is observational in nature and only aims to record the outcomes in patients that may have undergone a procedure with a particular device or drug. In the case of a registry, the intervention has already occurred, and the outcomes of that intervention are being recorded. In this way, registries provide what is called ‘real-world data/evidence’ or RWD/E.
Clinical Trials– The primary difference between a trial and a registry is the ‘intervention’. A trial focuses on an intervention and prospectively collects data. Trials may be conducted in a controlled environment which is why they may not mimic real-world use; however, they provide outcomes on the safety and efficacy of the intervention under controlled conditions. This is also why manufacturers who may have pre-market clinical trials data are encouraged to perform PMCF activities to gather RWD/E in order to understand potential device risks outside a controlled clinical trial setup.
We at Bannick, LLC are experienced at evaluating options for your PMCF activities. Contact us to learn how we can partner together and determine which approach is best for your unique situation.
#bannickprimary #medicaldevices #medtech #medicaltechnology #clinicalresearch