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# Advancing Use of Patient-Reported Outcomes
- URL: https://www.fdaweb.com/advancing-use-of-patient-reported-outcomes/
- Published: 2019-05-16T12:00:00.000Z
- Updated: 2026-09-15T01:27:21.000Z
- Author: David McFarland
- Tags: Drugs, Devices, #legacy-id-D5144123

Three researchers say effort needs to be increased to incorporate patient-reported outcomes (PROs) as a data source for real-world evidence. Writing online in the journal *Nature Reviews Drug Discovery*, the researchers say that as pressures from legislation, international regulatory authorities, and patient groups promote more patient-centric drug development and evidence generation, attention is turning to the role of PROs to provide the patient perspective in real-world data sets.

The article looks at some of the current challenges in PRO real-world evidence and gives the researchers’ vision and strategic priorities. Priorities, it says, are: 

- ensuring international collaboration across stakeholders including patients, caregivers, clinicians, regulators, ethicists, industry, payers, and policymakers to agree to a standardized approach to PRO assessment;
- developing a comprehensive standard set of recommendations, methods, and tools applicable to generation of real-world evidence based on PROs in different settings;
- formulating a clear governance process for generation of real-world evidence based on PROs;
- establishing standard sets of PRO measures, electronic tools, and administration schedules to raise the bar;
- developing and using electronic PROs wherever possible;
- minimizing workload and technical complexity for patients, clinicians, and health providers;
- carefully considering the objectives of PRO assessment and their timing;
- ensuring data collection is findable, accessible, interoperable, and reusable;
- providing guidance on how to interpret and use the data; and
- ensuring patients and clinicians gain value from assessment through real-time access to PRO data to tailor care to individual needs.