Dr Nicholas Robert Discusses How Real-World Data Can Complement Clinical Trial Data

With real-world data, there's an opportunity to take a new agent and see how patients outside that clinical trial would do, explained Nicholas Robert, MD, medical director of Data, Evidence & Insights, McKesson Life Sciences.

Transcript

With the increased prevalence of real-world data in recent years, do you see a future where real-world data will replace clinical trials? Or will it be complementary to clinical trials and help fill in data gaps?

I think the short answer is complementary. I think it’s hard to imagine how a new agent, except for the situation where the tumor is uncommon, but for a general situation where the tumor is a common tumor and you’re trying to develop a new treatment, doing a randomized prospective trial, I think will still be the gold standard. Albeit, after that approval the opportunity to expand application, to find new patients that might have benefit—because one of the criticisms of randomized trials is that they’re very selective, very restrictive. In the real world, it’s just that. There are all kinds of patients with all types of comorbidities. Their blood count may not be the same, their chemistries, etc.

And there’s an opportunity to take a new agent and see how patients outside that clinical trial would do. And we actually did this in a situation with metastatic breast cancer where we took results from a clinical trial—it was a successful trial. We took that treatment that was successful and looked at our real-world data and the good news was that it wasn’t as restrictive as the clinical trial. We found similar benefits, so this was a confirmation. There were situations where the doctor will be asked by a patient, “Oh, it worked on a clinical trial, does it work in others?” And there is now the opportunity to say yes it worked in other people, not just patients on the clinical trial.