Use of patient-reported outcomes (PRO) data to complement exposure-response analysis in early clinical cancer drug development

• Główni autorzy: Huiming Xia (Autor), Brian P. Booth (Autor), Yaning Wang (Autor), Chunling Fan (Autor), Vishal Bhatnagar (Autor), Paul Kluetz (Autor), Jeanne Fourie Zirkelbach (Autor)
• Format: Książka
• Wydane: SpringerOpen, 2023-11-01T00:00:00Z.
• Hasła przedmiotowe: article
• Dostęp online: Connect to this object online.

Abstract Background This proof-of-concept retrospective case study investigated whether patient-reported outcomes (PRO) instruments, designed to capture symptomatic adverse event data, could identity a known exposure-response (ER) relationship for safety characterized in an original FDA analysis of...