Dr James Hamrick Discusses the Importance of Real-World Data

James Hamrick, MD, MPH, Kaiser Permanente and Flatiron Health, discusses the importance of real-world data and how it augments traditional clinical trial data.

What is the importance of real-world data and how do we ensure greater use of it?
Real-world data is just an enormous opportunity. So, real-world data, real-world evidence, and pragmatic clinical trials are never going to replace traditional clinical trials—they shouldn’t. They should augment them. And, so, they can make us design smarter, traditional trials.

There’s a virtuous cycle of real-world data generation, using that to generate evidence that makes us design smarter protocols for traditional trials, and then that cycles through to clinical care. So, if you think about that cycle, if you can understand, for instance, what’s happening in standard of care out in the community, and you’re writing a protocol, that’s going to inform your control arm and it’s going to make sure that the traditional trial you run gives you the relevant answers that you need and that the patients need and that the doctors need to really roll out the new treatment out into the real world.

Now, to make real-world data useful, it has to be exceptionally, scientifically rigorous. So, one thing that we’re doing at Flatiron, is we’re doing a lot of time partnering with the FDA, working on publications to be released in to the peer-reviewed literature, because we want to be very transparent on our methods and make sure that they’re completely scientifically rigorous, and that they’re vetted in the peer-review format by the scientific community. Because there’s an enormous amount of potential learning that we can have from the data that’s generated at the point of care, but you have to be very careful, so you don’t draw spurious conclusions and so that it really helps us understand what is happening in the field.

As we move toward more value-based care models, how does real-world data have more importance?
Real-world data really does have an important place in the value-based care world, because it’s going to help us understand things that we never understood before. We’ve extrapolated from traditional clinical trials what we expect to happen.

You can imagine a world where we really have a real-time snapshot of what’s going on in cancer care in the United States, and we can use that for things like understanding how reimbursement should work, how incentives should work, in order to get us all to the goals that we want, which is super high-quality care based on outcomes that patients care about, that’s at a good value. So, that’s not breaking the bank. And that if we’re going to pay a lot, we’re getting excellent results.

I think real-world data and real-world evidence, if it’s high-quality and rigorous, is really going to enable us to be smarter about how we deliver high-value care.
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