Patient Experience Data: US FDA’s Evidentiary Standards Should Reflect Intended Use

20 Sep 2018

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of the data throughout a drug’s lifecycle, stakeholders say in comments on FDA’s first patient-focused drug development draft guidance; industry and advocates push for clarity on interactions to discuss patient experience studies with FDA staff and the promotional implications of such data.

The US FDA should clarify the level of rigor needed for collecting patient experience data based upon how that information will be used in a drug’s development, industry and advocacy groups tell the agency.

In comments on a June draft guidance on collecting comprehensive and representative input, stakeholders pressed FDA to better define the...