FDA’s Real-World Evidence Program – Summary of Patient Data Assessment Report

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Author: Carrie Britton | Date: July 28, 2021

The FDA is responsible for ensuring the safety and effectiveness of regulated medical devices and assuring that patients have timely access to the devices while advancing innovation. It is a balance—one that adequately protects the public without stifling progress.

Previously, to ensure medical device manufacturing compliance, a manufacturer would provide data from prospective randomized controlled trials to demonstrate the safety and efficacy of its device. Nevertheless, this was not a viable option for some medical devices, as device limitations or specific disease conditions required alternative approaches that allowed for increased flexibility in trial design and statistical analysis.

With the proliferation of Real-World Data (RWD) about patient health status and the delivery of health data collected from sources such as electronic health records, registries, medical claims, pharmacy data, and feedback from wearables and mobile technology, the FDA expanded the use of real-world evidence (RWE) and patient experience data to support regulatory decision-making. This opens the door for manufacturers to use this data to support clinical trial designs and observational studies to fuel future product innovation and new treatment approaches.

To ensure the benefits of the FDA’s RWE program outweigh its risks—and pursuant to the 21st Century Cures Act of 2016—the agency recently published its first of three patient data assessment reports on the use of patient experience data. To do this, they contracted with Eastern Research Group, Inc., who completed a series of interviews with FDA staff, applicants, and external stakeholders (patients, caregivers, clinicians, representatives of advocacy/research organizations) aimed at answering three questions:

• How does the FDA use real-world evidence or patient experience data in regulatory decision-making?
• How do FDA staff, applicants, and external stakeholders characterize (a) use of patient experience data in regulatory decision-making and (b) FDA communication about using these data?
• What good practices and opportunities for improvement exist for (a) use of patient experience data in regulatory decision-making and (b) FDA communication about using these data?

Overall, the report gives the FDA’s real-world evidence framework and processes a positive review. However, interviews with FDA staff point to the continued evolution of patient experience data, while stakeholders said they are still unclear as to exactly how the FDA utilizes real world evidence in its regulatory decision-making process. The report also includes some ideas about how the FDA and the industry can be more consistent in how patient experience data is used in application approval decisions.

What exactly does this all mean? In short, the FDA’s real-world evidence program is headed in the right direction—but there is still much to be figured out.

To access the full report or learn more about how the FDA uses real-world evidence, click here. If you have more questions, our experts are here to walk you through the report, talk to you more about the FDA’s real-world evidence framework and explain what it all means to you.

If you need help navigating the medical device FDA approval process overall, we can help with that, too! Click here to find out more.

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