Voice of the Patient

This report explores the growing importance of the voice of the patient across the entire drug development lifecycle. Readers will learn how patient insights increasingly shape clinical trial design, regulatory review, payer decision-making, and commercialization strategies in an environment defined by pricing pressure, rare-disease growth, and accelerated launch cycles.‍

“Beyond shaping evidence generation, the voice of the patient extends across the entire drug development life cycle, informing everything from early research and clinical trial design to commercialization, market access, and post-market surveillance.”

The full report examines why embedding patient perspectives at each stage of development is now essential for reducing R&D risk, aligning therapies with real-world needs, and demonstrating value to regulators and payers.

Thanks to FCA's Fall 2025 intern, Carson Moore, for authoring this report.