HEOR Case Study 2
Challenge:
Our client wished to submit a PRO claim (to be submitted to the FDA) related to patient reported symptoms associated with an investigational therapy. The PRO instrument was selected for the Phase III trial prior to Lifecycle Sciences group involvement.
Solution:
- Provided strategic consulting for obtaining a PRO label
- Developed the conceptual model, endpoint model, and conceptual framework to support the instrument selection
- Conducted targeted literature searches
- Convened several Scientific Advisory Panel meetings to review study materials
- Adapted, validated, and pilot tested the instrument to be used in the clinical trials
- Conducted the statistical analysis of the PRO data Developed a comprehensive PRO dossier for submission to the FDA
