Patient-reported outcomes (PROs)

Patient-reported outcomes (PROs) are direct reports from patients about their symptoms, functioning, or quality of life, without interpretation by clinicians.

What are patient-reported outcomes (PROs)?

PROs are measurements based on patient input that capture how a treatment affects their daily life. These may include pain levels, fatigue, mobility, emotional well-being, or treatment satisfaction. PROs are typically gathered through validated questionnaires in both trials and real-world settings.

Why are PROs important in pharmaceutical development and access?

PROs provide insight into treatment impact from the patient’s perspective, which can complement clinical and safety data. They are increasingly valued by regulators, HTA bodies, and payers, especially in conditions where traditional endpoints may not capture meaningful benefit.

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