Dr Scott Gottlieb Discusses Use of Real-World Evidence

The marketplace is working to analyze and clean up real-world evidence so it can be used to inform decisions on treatment and coverage, said Scott Gottlieb, MD, former FDA commissioner (2017-2019).

Transcript

Quality of real-world evidence is a significant concern. Do you see a role for a third-party entity or professional societies, along with FDA, in creating standards for its use?

Well, we’re seeing a lot of third-party entities grow up to help improve the quality of the data that’s being generated with real-world evidence. Not just not-for-profit bodies like what FDA did on the medical device side through the creation of NEST [National Evaluation System for health Technology] a consortium of entities to help consolidate information and provide certain certifications, if you will, of the reliability of that information. But even in the private market, we’re seeing companies grow up that are helping gather the data and do the evaluative work and clean it up, if you will, to make sure you can glean rigorous conclusions from the real-world evidence.

So, I think the marketplace is taking care of a lot of these challenges itself.

Have payers been at the table in the process, and if so, what has been their role?

Well, if you look at the companies that are engaged in trying to develop real-world evidence to help pharmaceutical development, they’re also marketing to payers. So, payers are interested from what I see, or from where I sit, in trying to use real-world evidence to help inform their own decision making about how they deploy products—which products they ultimately cover—how they make different coverage decisions.

I think there’s a real interest in seeing how it can be applied at a patient level—including with health systems I think looking at some of the platform. I think the ability of payers and providers to use real-world evidence to inform decision making is going to improve as the availability of this information becomes more ubiquitous, lower cost, and as the platforms for sort of accessing it become more at the point of care.

We’re seeing companies enter the market—I don’t want to talk specifically about any individual company—but, there are companies entering the market, including venture-backed companies, with the goal of trying to democratize real-world evidence, and try to bring it on to platforms that allow more ready access to payers and providers. So, it isn’t just something that you do in a very carefully constructed setting, in the context of like a pharmaceutical development program.