You spin me right 'round baby, right 'round: RWE in Regulatory Decision-Making

There has been such a whirlwind of activity around real world evidence (RWE) generation, especially its use in regulatory decision-making (RDM), that I feel like the band Dead or Alive being spun 'round (like a record). In addition to publishing the Framework for FDA's Real-World Evidence Program, the FDA is making a massive effort trying to release guidance documents (https://www.fda.gov/science-research/science-and-research-special-topics/real-world-evidence) and hold meetings around the use of RWE in RDM in an effort to increase the use of real-world data (RWD) to generate RWE after the 21st Century Cures Act (https://www.fda.gov/regulatory-information/selected-amendments-fdc-act/21st-century-cures-act) was passed in 2016.

It looks like RWE is lots of fun, so, I've set my sights on RWE and nothing else will do (think song lyrics). Even the think-tank Bipartisan Policy Center made a recommendation several months ago to expand the use of RWE in not only regulatory decision-making but also payment decision-making (https://bipartisanpolicy.org/report/expanding-the-use-of-realworld-evidence-in-regulatory-and-value-based-payment-decision-making-for-drugs-and-biologics/).

All I know is that, to me, RWE is having fun (think song lyrics). Even at HealthCore, we're having fun with RWE generation with the rich data eco-system we've created. The backbone of our data environment is based on our unparalleled data assets that not only utilize medical and pharmacy claims but also integrate lab results, clinical data, patient-reported outcomes (PROs), healthcare utilization, social determinants of health (SDOH), and cost data providing a more complete picture of patient care. We are finding evidence and truth at the CORE of healthcare (https://www.healthcore.com/).

Watch out, here I come (think song lyrics). A key driver of change in healthcare and using RWD are large-scale alliances and collaborations, such as FDA Sentinel, IMEDS, PCORnet, and, of great interest to the clinical research community, the NIH Collaboratory (https://rethinkingclinicaltrials.org/). And in my area, Clinical Research, we are able to successfully utilize RWE-generation across the spectrum of Phase II-IV trials, PCTs, post-market surveillance, and registries. It is exciting to see how we can use RWE in regulatory decision-making, understanding of course, that RWD has its own set of challenges. But we're moving just a little closer (think song lyrics) and the evolution of the clinical trial design away from the "gold-standard" of placebo-controlled or concurrent controls is exciting. Are you a convert yet? Let's continue this conversation.

RWE, you spin me right round, baby, right round like a record, baby right round. (Now if this song is not completely stuck in your head, here is the "official" You Tube video in order to get it stuck in your head: https://www.youtube.com/watch?v=PGNiXGX2nLU … You're welcome!)