PURPOSE: To highlight opportunities, challenges, and potential solutions for developing, implementing, and interpreting performance outcome (PerfO) assessments to assess patient functioning in drug development. Participants will hear the current thinking of the regulators on developing and implementing PerfO assessment to support drug development and important considerations when implementing PerfO assessments in clinical studies including special considerations in pediatric patient populations. A case study will showcase the development and implementation of the Multi-luminance Mobility Test (MLMT), a standardized obstacle course for assessment of visual function in low vision. DESCRIPTION: Participants will be presented with evidentiary, methodological, and operational considerations for developing and implementing PerfO assessments to support drug development by speakers from the regulator, industry, and academia. The workshop will 1) provide an overview of the FDA’s current thinking of supporting PerfO assessments as fit-for-purpose outcome measures that reflect meaningful interpretation of daily-life functioning; 2) share practical considerations for implementing PerfOs in clinical trials and standardizing training; 3) highlight special considerations of implementing PerfO assessments for pediatric patient populations; 4) present the development of the MLMT as a case study. Dr. Patel will provide an overview of FDA’s current thinking on PerfO assessment including the working definition, the evidentiary considerations for demonstrating that PerfO measures reflect daily-life functioning, and the challenge of determining meaningful within-patient change. Dr. Rooks will share the experiences on implementing PerfOs as key outcomes in clinical trials and on standardizing training of study staff to improve the data quality. Dr. Adams will present the special considerations for the design and implementation of PerfO assessments in pediatric patient populations including the span of the developmental range of the PerfO assessment and the understanding of child development at different ages. Dr. Chung will present the development of the MLMT, which was used successfully to support a drug development program.