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Patient experience data - FACILITATE

Patient experience data

Data that is collected by family or friends and is intended to 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.

FDA-Collecting patient experience data: how you can best help FDA?

https://www.fda.gov/media/112163/download

More resources

EMA-Patient experience data in EU medicines development and regulatory decision-making Outcome of the workshop on 21 st September 2022

https://www.ema.europa.eu/en/documents/other/executive-summary-patient-experience-data-eu-medicines-development-regulatory-decision-making_en.pdf

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