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# Workshop on Patient Experiences in Clinical Trials
- URL: https://www.fdaweb.com/workshop-on-patient-experiences-in-clinical-trials/
- Published: 2018-09-17T12:00:00.000Z
- Updated: 2026-09-15T00:32:14.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5142366

FDA is hosting a 10/15-16 public workshop to convene a discussion on: **1**) methodological approaches that may be used to develop and identify what is most important to patients and caregivers with respect to burden of disease, burden of treatment, and the benefits and risks in managing a patient’s disease; and **2**) best practices for selecting, developing or modifying fit-for-purpose clinical outcome assessments to measure patient experiences in clinical trials. An [FDA notice](https://www.fda.gov/Drugs/NewsEvents/ucm607276.htm?ref=fdaweb.com) says the workshop will inform development of patient-focused drug development guidance as required by [Section 3002 of the 21st Century Cures Act of 2016](https://www.fda.gov/downloads/ForIndustry/UserFees/PrescriptionDrugUserFee/UCM563618.pdf?ref=fdaweb.com), and as part of commitments made by FDA under the [sixth authorization of the Prescription Drug User Fee Act.](https://www.fda.gov/ForIndustry/UserFees/PrescriptionDrugUserFee/ucm446608.htm?ref=fdaweb.com)