The Rise of Real-World Data
What happens when the real world shows a different version of your reality?
One of our more progressive clients has me thinking about real-world data and how that data produces real-world evidence. Real-world data is the record of what happens regularly among regular people: insurance claims are real-world data. Records from prescription purchases are real-world data. The steps your fitness tracker records become real-world data. As this real-world data turns into real-world evidence, it finds its way into the rarified world of scientific studies.
So, for instance, the authoritative results from randomized clinical trials are beginning to be combined with real-world evidence. These new data sources enrich the data carefully curated through randomized clinical trials.
Stay in your lane, real-world.
Part of me prefers the antiseptic-clean, clinical models of life that yield to thinking on paper and carry none of the messiness of mixed-up relationships, feelings of disappointment, human weakness, illness, and death. So, in other words, I want to live in a fictional world.
Evidence from the real world too often challenges my carefully constructed models. Just like it does for randomized clinical trials, where the controls produce authoritative evidence, but that evidence goes only so far. For instance, if you add claims data to the mix, a more nuanced picture emerges. Add data from wearables and pharmacies, and the story changes slightly.
Evidence from the real world is something we would all seem eager for. Wouldn’t we want to know if our theory about being invisible when we jog is true? My wife insists I am visible even when I jog. We all want to live out a truthier version of the truth. We like the idea of stepping across the solid ground of reality as we sojourn across this earth. Heck, we’ve built up all sorts of models for life on this planet, so we can be sure we’re living out our truth. Whether it’s the model of not stepping on cracks (to avoid breaking mothers’ backs) or the model of tossing salt over the shoulder, or the model of avoiding news sources that don’t confirm our biases—we’ve created shortcuts to ensure we do the proper thing, per the models we’ve constructed or adopted from our tribe.
How can we stay open to real-world evidence, even if that evidence contradicts our models of the world? I see at least three ways.
#1 Let experience open a conversation
When my experience differs from what my model says, that is a point to pause and speak out. Back to the news: when I read a story that I know something about already, but that story does not include critical information, I know that model is not as accurate as it could be. So I tell someone.
The subsequent conversation clarifies the point and sometimes muddies the issue. But the out-loud processing cements it on my radar and gets it in front of other people. And if I can make build up my “conversational receptiveness,” perhaps something brand new can come from that conversation.
The gap between what I thought was true and what is really happening is worth exploring. It helps no one to ignore those differences.
#2 Question authorities
Scholar James Sanders, in his book about his relationship with authoritative texts (in Sander’s case, the Torah/Old Testament), noted the delicate balances around what is “authoritative” for a community (texts repeated often end up being authoritative, eventually becoming “canon”) and the boundaries that are all but invisible for those within the community:
“The moment one asks why such material bears repeating, however, he or she is engaged in the questioning of authority.” [i]
One of the reshaping, even disrupting, elements that real-world evidence brings is the experience data that impinges on what someone already knows. It says something different.
While real-world evidence probably will not point in the opposite direction, it may create a more nuanced picture than you had assumed. It’s not because my canon, my randomized clinical trial, was necessarily wrong; it’s just that I might have been reading it from a limited perspective. With a little help from real-world evidence, I can thread the needle of this story differently, and the truth gets a bit truthier. Naturally, hearing people from diverse backgrounds and experience help us get a more accurate take on the truth we think we understand.
#3 Let the real world talk to your imagination
Once we start hearing from the real world, it makes sense to consider the new kinds of questions we might ask and the unique way we might ask those questions.
For instance, the FDA cited a study looking at whether FDA-approved drugs used for treating ADHD could cause serious cardiovascular events in children.[ii] Studying the issue was difficult because the events were rare, and a proper randomized clinical trial would need to be huge to get authoritative results.
Instead, they enlisted the help of four health plans that shared RWE for more than a million children and young adults (properly HIPAA-compliant). From that new way of asking the research question, they concluded the drugs did not carry an increased risk of serious cardiovascular outcomes.
In the same way, asking what our clients need and want has always had a way of breaking through the assumptions and conclusions we develop on our siloes. And as a writer, I’m learning that talking an idea over with a real live person before writing a book about it will help direct the concept in ways that make it more marketable.
Letting the real world in has kind of a love-hate sense about it. But we do well to look for ways to respond to real-world data and real-world evidence.
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[i] Sanders, J. A. From Sacred Story to Sacred Text: Canon as Paradigm. Philadelphia: Fortress Press, 1987. 21
[ii] Research C for DE and. Real World Evidence – From Safety to a Potential Tool for Advancing Innovative Ways to Develop New Medical Therapies. FDA. Published online February 24, 2020. https://www.fda.gov/drugs/news-events-human-drugs/real-world-evidence-safety-potential-tool-advancing-innovative-ways-develop-new-medical-therapies