The FDA has released draft guidance on the “Use of Real-World Evidence to Support Regulatory Decision-Making for Medical Devices”.  The principles underlying this guidance have important – and advantageous – implications not only for device manufacturers but also for clinicians.

The FDA states that real-world evidence (RWE) “may provide an efficient means of generating the necessary clinical evidence to support regulatory decisions”.   However, the guidance also emphasizes that data quality, good clinical practice, proper study design, longitudinal outcomes data and other traditional methodological considerations remain critical.

The FDA enumerates many potential sources of RWE.  Nevertheless, it is clear from the guidance that only specific types of real-world data (RWD) surrounding a discrete category of clinical interventions, and causally correlated to longitudinal outcomes, will generate acceptable “study-specific derived dataset(s).”

This means that busy clinicians and their patients are essential to developing the RWD which can be converted into RWE.  It is those already over-worked clinicians who are best positioned to design, capture and analyze study-specific RWD.  It is their patients who must report long-term outcomes against standardized assessment measures.  The overriding question is: where is the time or incentive to do so?

The technology and processes underlying each Circle is “fit-for-purpose”in the context of any RWE objective to comply with the FDA’s guidance.  (Indeed, the U.S. patent underlying Circles is titled “Method and System For Processing Large Amounts of Real-World Evidence”.)  Moreover, Circles eliminate administrative burden for clinicians in generating RWE, while developing accompanying ethical professional and financial incentives.

Please contact us to find out more.