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# Guide on Collecting Patient Experience Data
- URL: https://www.fdaweb.com/guide-on-collecting-patient-experience-data/
- Published: 2020-06-16T12:00:00.000Z
- Updated: 2026-09-14T16:18:16.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5147023

FDA has made available a guidance entitled “[Patient-Focused Drug Development: Collecting Comprehensive and Representative Input](http://s2027422842.t.en25.com/e/er?utm%5Fcampaign=FDA%20Finalizes%20Patient-Focused%20Drug%20Development%20Guidance%20on%20Collecting%20Comprehensive%20and%20Rep&utm%5Fmedium=email&utm%5Fsource=Eloqua&s=2027422842&lid=13819&elqTrackId=73DAB7C3E64CE3CE8B985B80132A31B0&elq=1c0189196ab44159829a95a212cd8276&elqaid=12965&elqat=1).” The document addresses how stakeholders (patients, researchers, medical product developers, and others) can collect and submit information on the patient experience for medical product development and regulatory decision making. It is part of a series of guidance documents intended to facilitate the advancement and use of systematic approaches to collect and use robust and meaningful patient and caregiver input that can more consistently inform medical product development and regulatory decision making.

  
Patient experience data are defined in the guidance as “data that (**1**) are collected by any persons (including patients, family members and caregivers of patients, patient advocacy organizations, disease research foundations, researchers and drug manufacturers); and (**2**) are intended to provide information about patients’ experiences with a disease or condition, including (**A**) the ‘impact (including physical and psychosocial impacts) of such disease or condition or a related therapy or clinical investigation; and (**B**) patient preferences with respect to treatment of the disease or condition.”

The guidance also presents a general overview of methods and approaches for collecting patient experience data rather than focusing on methods for a specific, single purpose, e.g., to support collection of clinical outcome assessment data or patient preference information.