This white paper addresses the growing importance of patient-reported tolerability as a complement to traditional safety and efficacy measures. It explains how tolerability influences adherence, persistence, and overall treatment success, particularly in chronic and long-term therapies. The paper outlines best practices for defining tolerability concepts, designing patient-centered instruments, and integrating patient-reported data into clinical development and post-marketing studies. It also discusses regulatory considerations and methodological challenges. By capturing the patient voice more effectively, organizations can improve decision-making, enhance benefit–risk assessments, and support more meaningful patient-centered evidence generation.

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