Defining and Collecting Patient-Reported Treatment Tolerability to Inform Drug Development

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.

Patient Centered Solutions

Capture the patient experience across the full trial process, from strategy to dissemination of results.

PCS Thought Leadership

IQVIA’s Patient Centered Solutions (PCS) team are experts in the measurement of the patient experience during intervention development. This includes the use of Clinical Outcome Assessments (COAs) which consist of Patient Reported Outcomes (PROs), Clinician Reported Outcomes (ClinROs), Observer Reported Outcomes (ObsROs), and Performance Outcomes (PerfOs). Below we highlight several of our publications that we make available for download that provide deeper insight on how best to capture and analyze this important patient data.

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