Patient experience data
Patient experience data includes data that provide information about patients’ experiences with a disease or condition. Patient experience data can be interpreted as information that captures patients’ experiences, perspectives, needs, and priorities related to (but not limited to): 1) the symptoms of their condition and its natural history; 2) the impact of the conditions on their functioning and quality of life; 3) their experience with treatments; 4) input on which outcomes are important to them; 5) patient preferences for outcomes and treatments; and 6) the relative importance of any issue as defined by patients.
Officially, patient experience data is defined in Title III, section 3001 of the 21st Century Cures Act, as amended by section 605 of the FDA Reauthorization Act of 2017 (FDARA)1.
U.S. Food and Drug Administration (FDA) Patient-Focused Drug Development Glossary
U.S. Food and Drug Administration (FDA) to Collect Patient Experience Data [2018 published article]