White Paper
Defining and Collecting Patient-Reported Treatment Tolerability to Inform Drug Development
Best practices for its measurement in clinical trials
Nov 07, 2025
The pharmaceutical industry is increasingly incorporating an assessment of patient-reported treatment tolerability in their clinical trials, mainly driven by the FDA requirements. Treatment tolerability is a multidimensional concept that has evolved significantly over the past 25 years. Despite increasing recognition of its importance for patient experience, regulatory decisions, and clinical management, there is no universally accepted framework for defining or assessing tolerability, especially from the patient's perspective. This white paper aims to clarify the concept, review regulatory guidance and recent approvals, and recommend best practices for its measurement in clinical trials.

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