Workshop on Patient Experience Data in Drug Development

FDA is announcing a two-day (9/18-19) virtual public workshop to address methodological challenges in collecting and using patient experience data to inform drug development and regulatory decision-making. The “Patient-Focused Drug Development: Workshop #2” is the second in a series mandated by the user fee program and intended to discuss how patient and caregiver perspectives can be more systematically incorporated into benefit-risk assessments, product labeling, and clinical outcome assessments, according to an agency notice. 

Topics will include best practices for gathering reliable patient experience data, evaluating submissions, and overcoming methodological hurdles. The agency will also present a draft version of an updated “evidence dossier template,” designed to help sponsors more effectively submit patient experience evidence in support of clinical outcome measures.