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

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

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...

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Bibliographic Details
Main Authors: Huiming Xia, Brian P. Booth, Yaning Wang, Chunling Fan, Vishal Bhatnagar, Paul Kluetz, Jeanne Fourie Zirkelbach
Format: Article
Language:English
Published: SpringerOpen 2023-11-01
Series:Journal of Patient-Reported Outcomes
Subjects:
Patient reported outcomes
Exposure–response analysis
Drug development
Dosage optimization
Adverse events
Online Access:https://doi.org/10.1186/s41687-023-00651-2

Internet

https://doi.org/10.1186/s41687-023-00651-2

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