Patient-reported outcomes (PROs) from clinical trials are critical to understanding how patients feel and function during treatment for a disease or condition.
PROs report patient health status directly, without interpretation, providing information that supplements clinician-reported, observer-reported, and performance outcomes.
When PRO results are in the drug label, the information can be used in promotion. In any case, PRO results can be shared in scientific communications, and incorporated in health technology assessments, Academy of Managed Care Pharmacy dossiers, and other similar submissions.
This presentation will examine the role of PROs in clinical drug development from the HEOR perspective, focusing on:
- U.S. regulatory environment,
- Comparisons with Europe,
- Differences by therapeutic area, and
- Practical considerations for clinical trial study design and communication.