Using Real-World Data for FDA Regulatory Decision-Making

In May, precision medicine tech company Cota announced it signed a two-year research collaboration agreement with the U.S. Food and Drug Administration (FDA) Information Exchange and Data Transformation Program to establish a study protocol with an initial focus on breast cancer.

The scientific relationship will allow the organizations to apply digital tools developed by Cota to a rich depository of real-world data on breast cancer. Even more, the collaboration will provide the FDA with information on the evolving treatment landscape and insight on treatment variation within the subpopulation of patients with the disease.

The agreement could also support the agency’s goal to understand the broader treatment of cancer through the application of real-world evidence.

“I think that the FDA has clearly signaled in the last year or more that it is interested in the potential to utilize real-world data and the evidence generated from that data for regulatory decision-making,” Andrew Norden, M.D., chief medical officer of Cota, told Inside Digital Health™.

Electronic health records were not designed to efficiently enable analysis of data across a population of patients, Norden said. But people in the healthcare industry and academia are developing techniques to allow the extraction and analysis of data.

“In my view, it would be foolish not to take advantage of that data when we look to understand how cancer care is delivered in the U.S.,” Norden said.

The FDA appears to agree with that level of thinking, he added.

Clinical trial patients are highly selected and tend to be healthier, wealthier, white and male.

“The value of real-world data and evidence is that you can look to extend the findings of clinical trials to a more broadly represented patient group,” Norden said.

Today, the methods and capacity of real-world evidence to answer questions is in an immature stage. And the FDA, along with many others in the healthcare industry, is looking to learn how real-world evidence and data can work and be applied.

There is great potential for real-world data to accelerate clinical trial findings and get drugs to market more quickly when there’s strong evidence in favor of their use.

“So, that’s what we are looking to do,” he said.

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