OBJECTIVES : Under the fifth Prescription Drug User Fee Act (PDUFA V), the Food and Drug Administration (FDA) held a series of Voice-of-the-Patient (VoP) meetings intended to improve medical-product development by gathering patients’ perspectives on their condition and treatments. This analysis explored most common themes identified across the 27 FDA-led and 23 externally-led VoP meetings with available reports.

METHODS : Publicly available VoP meeting reports were retrieved from the FDA or, for externally-led meetings, corresponding patient-advocacy organization websites. Data were extracted by three researchers and thematically analyzed. Four categories were created for common symptom themes: physical symptoms, mental impacts, psychosocial burden, and work/finance/social burden. Eight categories were created for common treatment themes: condition characteristics, benefits and risks, barriers, prescription treatments, alternatives to drugs, future treatment needs, clinical-trial design, and placebo.

RESULTS : Common symptom themes: Mental impact subthemes included psychological impact (n=48); work/finance/social burden subthemes included participating in physical or social activities (n=40), unable to work/workplace concerns (n=39), performing ADLs/chores (n=35); Physical symptom subthemes included sleep disturbance (n=35), pain (n=35), and fatigue (n=34); and psychosocial burden subthemes included quality of life (n=35), worry about and living with uncertainty (n=33). Common treatment themes: benefits and risks subthemes included side effects (n=42), risk and benefit tradeoff (n=26); barriers subthemes included financial burden/unaffordability (n=32), fair access to medications (n=29); alternative treatments to prescriptions subthemes included diet modifications (n=34), dietary supplements (n=31); condition characteristics subthemes included substantial symptom heterogeneity (n=30); and future treatment needs subthemes included need for additional therapies (n=36), treatment with less side effects (n=29), and need for disease modifying treatment (n=25).

CONCLUSIONS : Examination across diverse VoP reports provides insights across diverse patient populations and illnesses on patient-experiences. Common themes emerged that can help stakeholders understand the symptoms, impacts, and challenges patients face. These findings can be useful in medical-product development and value assessment.