Danielle Gentile, PhD, a senior scientist on Cardinal Health’s real-world evidence and insights team, discusses her research comparing diversity in real-world evidence, RCTs, and SEER data in patients with metastatic breast cancer. The study was presented at the 2023 ASCO Annual Meeting in Chicago, IL.

Transcript:

Dr Danielle Gentile: Hi, I am Danielle Gentile, and I'm a senior scientist on Cardinal Health's real-world evidence and insights team.

Can you please give some background about your study and what prompted you to undertake it?

Dr Gentile: Our study does a comparison of evidence data, randomized control trial data, and SEER data. SEER is a data registry of patients with cancer across the US. So we were curious to find if there were differences in demographic characteristics across those three sources. 

So we compared age, ethnicity, and a few other select demographic characteristics across the three sources.

Please describe how the study was conducted.

Dr Gentile: We used all secondary data. And we had data from real-world evidence that was part of previous studies that we have conducted inside of Cardinal Health. So that gave us the real world evidence. And then the other comparison was randomized controlled trials. So we took the inclusion and exclusion criteria from the real-world evidence and applied it to the both similar randomized controlled trials that have been published.

And again, we use those same criteria to look in the SEER registry database for similar patients. So we were looking in terms of cancer type, and here it is breast cancer for this particular abstract that we explored.

What were the key findings of your study?

Dr Gentile: We know that clinical trial participants tend to be younger in better health, have better social circumstances and so on. So the interesting findings that we saw were that the mean age at first-line therapy initiation for cancer, it was higher in our real-world evidence patients at 61.8 years and quite a bit lower in randomized control trial patients, 56.0 years. So it's helpful to see that we have an older population in real-world evidence because that represents the true patient population. And we know that randomized controlled trial participants tend to be younger and in better health.

And another interesting finding was that we had a better representation of black patients inside of real world evidence studies actually far greater. So, 25.3% of patients in the real world evidence studies were black or African-American and randomized controlled trial patients, only 2.9% were black or African-American. 

And the SEER data source, which is the registry data included 13.4% non-Hispanic black patients.

Looking ahead, what potential impact do you hope your findings will have on improving the representation of real-world populations in RCTs?

Dr Gentile: We know that participating in a randomized control trial, it requires a certain amount of being well enough to participate and also having access to the trial and having the social background and characteristics that would allow a person to say, attend their appointments, keep up with all of the follow-up that is required, but in the real world, it is care happens at the rate that it happens.

There is not so much rigor in terms of how a treatment is given, how often follow-up data is collected and how physicians keep track of how the patient is doing. Maybe different than it is in a randomized control trial, which has a much more rigorous design.

So if we look at real-world evidence, it can serve as a supplement to randomized control trial data. And we can see that in the real-world population we have better representation of ethnic diversity, of age, and those are things that we should be keeping in mind when we're drawing conclusions based on real-world evidence based on randomized controlled trials and also considering registry data about cancer.

What future studies would you like to see comparing real-world evidence to clinical trial data?

Dr Gentile: I can't say of any particular studies that are on ongoing or that we have planned, but this is more so a methodological paradigm that I'm hoping to see more of in the literature. And we know that the real-world evidence patients will have different characteristics than randomized controlled trial patients. So earlier, we mentioned randomized controlled trial patients tend to have less ethnic diversity, older, better wellbeing. So comparing them is not always possible to make a direct comparison because the populations do have different characteristics. But when we look at them in comparison to one another, we can draw some conclusions and see that the greater representation and real-world evidence of what the population is like out there in real clinics, in real settings, it helps us to get some insight into what's happening for patients in the treatments that they're experiencing.

Is there anything else you would like to expand on that you weren't able to include in your abstract?

Dr Gentile: I'd like to expand on some of the limitations that we experienced when we're comparing real world evidence to randomized controlled trials to the registry SEER data. And those challenges are that the data is often collected in different ways across different sources. 

One example is representation of Hispanic patients. So in the real-world evidence data, we have representation of Hispanic patients collected as Hispanic or non-Hispanic, whereas within the registry data, the Hispanic data is combined with the race data. So we can say non-Hispanic black or non-Hispanic white. And for some of their randomized controlled trials we reviewed, they did not report Hispanic ethnicity inside of their findings. So when we're looking across data sources, it is not always so easy to make those direct comparisons, but taking those comparisons with a grain of salt is beneficial because it gives us a better idea of what's happening out there in the real world.