'Real-World' Data: Watchword or Accurate Description?

Kathy D. Miller, MD


December 07, 2022

This transcript has been edited for clarity.

It's Kathy Miller from Indiana University.

As I was coming back from ASCO, I realized that a stroll through the poster session is a great way to get a sense of where the world is headed. If you look at the titles, you'll start to see the same words coming up over and over again, and that gives us some really important clues of what people think are hot topics in research.

The watchword this year was clearly "real-world data," and that's really important. We've known that our gold-standard randomized phase 3 clinical trials are more and more difficult to do and they're more and more expensive. We know that they enroll a very small subset of our patients.

Patients in clinical trials tend to be younger and healthier; they're more likely to be [White], have higher socioeconomic status, and higher health literacy. It doesn't mean that the results of those trials are not accurate and valid, but it does raise real questions about their generalizability.

The hope is that real-world data and increasingly sophisticated big data tools allow us to evaluate real-world data that will supplement and complement what we can learn from randomized clinical trials. As with any watchword, it gets expanded and people want to attach their research to that watchword, even if it's not accurate. That is definitely the case with "real-world data."

I saw abstracts supposedly reporting real-world data that in reality were reporting a single-institution tertiary referral experience. I saw patient registries that had a laudable goal of attracting a broader population of patients, but those registries were still done at centers that participated in clinical trials. They still required patient informed consent and submission of data to a database. Not surprisingly, when you looked at their population, it looked like the clinical trial population. The goal of attracting a broader group simply wasn't realized.

There are databases and ways of extracting data from large medical records systems that can really give us real-world data.

As you're looking at those reports, before you read too far, take a look at the patient population. Does it look like the clinical trial population or does it really meet the goals of going broader?

I'd love your thoughts on this. I'll be back with you soon.

Kathy D. Miller, MD, is associate director of clinical research and co-director of the breast cancer program at the Melvin and Bren Simon Cancer Center at Indiana University. Her career has combined both laboratory and clinical research in breast cancer.

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