Millie Long, MD, on Perusing Real-World Data in IBD

In this video Dr Long discusses her presentation at the Advances in Inflammatory  Bowel Disease 2020 virtual meeting on how data from clinical trials and real-world practice can help clinicians make the best choices for therapies for their patients with IBD.

Millie Long, MD, is a professor of medicine at the University of North Carolina at Chapel Hill.




Hi. My name is Millie Long. I'm at University of North Carolina, Chapel Hill. I'm one of the cochairs this year for the Advances in IBD meeting. I'd like to provide you with a brief summary on my talk of perusing real‑world data in inflammatory bowel disease during AIBD this year.

One of the aspects I've focused on is the differences between randomized controlled trials and real‑world data, helping to understand which study design is best in which scenario. RCTs are great for evaluating efficacy. They can certainly have some limitations.

One of the mnemonics I've provided you with was the 5 S's. RCTs can actually be pretty short. You can't look at long‑term outcomes. They can be very selective, so they're not generalizable. They're very expensive. That's one of the S's, as well.

Really, they're designed to help us to know, is this drug effective in a select population, which is very important. But that's not always the population we'll be using the drug in, in the real world.

Real‑world data is very helpful for looking at effectiveness, if someone stays on a therapy, if they stay clinically doing well, safety becomes very important. Understanding things like optimization of therapy, which isn't necessarily done in clinical trials, and important aspects in management, like withdrawal of therapy.

These real‑world data have taught us how to better use these therapies, and how to understand the safety complications that may or may not have been available during the randomized controlled trials.

Let me provide you with one example. We now recognize that with the anti‑TNF class in particular, we see these psoriasiform skin eruptions, this TNF‑induced psoriasis. Yet in all the RCTs that brought the TNFs to market, these complications were not recognized.

Again, real‑world data provides us with a better understanding and understanding the effectiveness of various treatments to manage this complication, as well.

The other thing that real‑world data is excellent at is safety. We discussed a number of very large registries that provide safety information for the various classes of medications, particularly the biologics currently in use for both Crohn's disease and Ulcerative colitis.

Overall, these safety data have been reassuring and certainly, some infectious complications, many of which may be preventable and important to recognize and counsel patients with early on.

Putting it all together for your clinical practice, RCTs are great for knowing if a drug is effective. From a real‑world perspective, use that long‑term data to understand long‑term outcomes, long‑term effectiveness and safety. Together, these 2 types of data will help us to better manage our patients. Thank you.