Patient Experience Data: US FDA’s Evidentiary Standards Should Reflect Intended Use
Degree of rigor may vary depending upon intended use of the data throughout a drug’s lifecycle, stakeholders say in comments on FDA’s first patient-focused drug development draft guidance; industry and advocates push for clarity on interactions to discuss patient experience studies with FDA staff and the promotional implications of such data.
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Agency has issued two of four methodological draft guidances required under 21st Century Cures Act and convened workshops on the two documents still to come; industry, patient groups applaud FDA’s initiative but point to gaps in the guidance series, particularly around interactions with the agency on patient experience data and approaches to collecting patient preference information.
Beyond submitting proposed guidances to FDA, stakeholders may develop patient registries, conduct natural history studies, and establish partnerships to help advance patient-focused drug development, agency suggests.
At public workshop, FDA says it will be flexible on clinical outcome assessments but stakeholders want agency to specify no-no's; digital health technology is appropriate to get more accurate endpoints, agency says.