Patient experience data as a methodological and strategic innovation in clinical trial design.

Patient experience data (PED) are increasingly recognised as a methodological and strategic innovation in drug development, yet their implementation in clinical trial design remains inconsistent. Drawing on a structured literature review and multistakeholder interviews, this analysis examines how PED inform endpoint decision-making. Although clinical development is shifting towards more patient-informed measures, challenges persist due to limited standardisation, validation, methodological gaps and operational constraints. Opportunities include early patient involvement, validated disease-specific measures, consensus-based core outcome sets and clearer regulatory guidance, enabling meaningful and structured PED implementation that strengthens evidence generation, reduces development risk and improves trial efficiency and real-world relevance.