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.

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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.

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