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

• Asıl Yazarlar: Huiming Xia (Yazar), Brian P. Booth (Yazar), Yaning Wang (Yazar), Chunling Fan (Yazar), Vishal Bhatnagar (Yazar), Paul Kluetz (Yazar), Jeanne Fourie Zirkelbach (Yazar)
• Materyal Türü: Kitap
• Baskı/Yayın Bilgisi: SpringerOpen, 2023-11-01T00:00:00Z.
• Konular: article
• Online Erişim: 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...