“Maybe stories are just data with a soul.” Brene´ Brown

Randomized trials have been the research gold standard for many years, for good reason. They give us an unbiased way of looking at the impact of medical interventions, and in turn let us know if our results are likely to be consistent, rather than just a one off.   But in today’s fast-paced environment we also need to know if our results are clinically meaningful and generalizable outside of the narrow terms of a research study. That’s where real-world evidence comes in.

Real-world evidence is more than just a complement to randomized trials – it has important advantages. It is inherently more inclusive.  Randomized trials tend to leave people out.  They select highly specific participants who might not have that much in common with the larger population.  Real-world evidence allows us to evaluate much larger samples by looking at sources academics haven’t always studied, including electronic health records, medical claims, product and disease registries, and patient-generated data from sources such as remote-patient monitoring devices.

Real-world evidence allows us to look at the impact of our interventions in an integrated way.  While there are many stakeholders who collect data – governments, academic centers, pharmaceutical and device manufacturers, payers and providers – traditional academic-based research often is siloed and slow to show results. Individuals often don’t fit neatly into a single box, and their paths through the healthcare system rarely follow a straight line. A person might be a Veteran who also is eligible for Medicare and has purchased private insurance as well.   Traditional research wouldn’t be able to reconcile all the information available in these disparate databases – real-world evidence can.

Real-world evidence allows us to help patients now.  Most medical research never enters clinical practice, and the research that does move from the bench to the bedside often is delayed by 17 years or more. Real-world evidence allows product development to be informed by real-time feedback and can accelerate time to market.  Real-world evidence also helps patients by decreasing the risk of harm.  Randomized trials are focused on internal validity. That means that adverse events often aren’t picked up until drugs and devices go into widespread use. Real-world evidence lets us quickly identify these signals and make necessary course corrections.

We live in a world where we are bombarded with information. Randomized trials still have an important role, and there is no better way to expose the snake oil salesmen of the world.  But real-world evidence is critical.  The happy paradox of real-world evidence is that by studying huge amounts of data we can find ways to personalize our interventions. Real-world evidence helps us find the soul within the data.