FDA Seeks Comments for Development of Two Workshops on Patient Experience Data

The FDA is seeking input on methodological challenges of collecting, evaluating and submitting patient experience data to help the agency plan two workshops on the topic.

The FDA is particularly interested in receiving comments about perceived barriers to the use of patient experience data for regulatory decision-making, as well as challenges and limitations in developing fit-for-purpose clinical outcome assessment measures.

The agency also asks that comments “describe any challenges and statistical analysis considerations ... in understanding whether an estimated treatment effect corresponds to a real difference in patients’ lives.”

Comments are due by July 1.

Read the notice here.

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