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

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 an appro...

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Detalles Bibliográficos
Autores principales:	Xia, Huiming, Booth, Brian P., Wang, Yaning, Fan, Chunling, Bhatnagar, Vishal, Kluetz, Paul, Fourie Zirkelbach, Jeanne
Formato:	Online Artículo Texto
Lenguaje:	English
Publicado:	Springer International Publishing 2023
Materias:	Research
Acceso en línea:	https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10656371/ https://www.ncbi.nlm.nih.gov/pubmed/37975967 http://dx.doi.org/10.1186/s41687-023-00651-2

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