Comparing Diversity in Real-World Evidence With Diversity in Clinical Trial and SEER Data

Scott Swain, PhD, director of real-world evidence at Cardinal Health, spoke with the Journal of Clinical Pathways in a follow-up interview to our conversation with study co-author Danielle Gentile, PhD. Drs Swain and Gentile and colleagues compared diversity across real-world evidence with clinical trial and SEER data in patients with metastatic breast cancer. Their research was presented in an abstract at the 2023 ASCO Annual Meeting.

Transcript:

Dr Scott Swain: I'm Scott Swain, director of real-world evidence with Cardinal Health.

What are the potential next steps following your study for future research and ensuring equity and access to health care?

Dr Scott Swain: So, I think that it's been pretty well established that there is still a remaining issue with the difference in diversity in real-world populations versus that in the patients that are currently participating in clinical trials, specifically in oncology. Those have been pretty well described. Trial patients tend to be healthier, younger, have better access to health care and higher education. I think that there's a lot of selective pressures that ultimately influence whether or not a patient ends up in a clinical trial.

And so, we've described that there is a problem. I think we even to an extent have done a pretty good job researching what the roots of those problems are, but in light that recent studies have shown that most patients of really all backgrounds are willing to participate in clinical trials, in my opinion the next step for research is to try to implement various techniques to increase the recruitment of diverse populations and to do a head-to-head comparison of those methods.

How can we ensure more accurate representation of real-world populations in RCTs?

Dr Scott Swain: So, I think that that is already in motion. I think that, as a result of FDA releasing a guidance recommending a diversity plan, which they will enforce, I also think that the movement towards precision medicine, which is going to result in more narrow and targeted clinical trial populations, that it will become absolutely necessary to include as many patients as you can find for certain indications. I also think that one of the underused use cases for real-world data is in screening for clinical trial participation. There's a couple different ways you can do that. You can screen individual sites to make sure that, when establishing a clinical trial, that you're using the right clinical sites in the first place that have the right patients. You can also use it to screen for patients for a clinical trial by going through the patient's medical records and then selecting those that might be eligible to your trial, but also keeping in mind having a diverse population.

Any final thoughts or anything you wanted to expand on?

Dr Scott Swain: Sure. So I think that the future of increasing diversity in clinical trials is going to be highly reliant on real-world evidence. So in addition to using real-world evidence to identify the right sites and the right patients, I think that placing trials in real-world settings through pragmatic and decentralized trials also helps with recruitment and retention. And because populations are getting smaller and they're harder to find, the idea of a decentralized trial makes a lot of sense, both from the patient's point of view, but also from the drug manufacturer's point of view.

And so, I really do think that that's an area that's going to take off in the future and I think that with the improvement in the type of real-world data that is collected and with better tools for collection and analysis, that the real-world data that can be collected alongside or in addition to clinical trial data is going to have more meaning.