The role of the estimand framework in the analysis of patient-reported outcomes in single-arm trials: a case study in oncology

Abstract Background Patient-reported outcomes (PROs) play an increasing role in the evaluation of oncology treatments. At the same time, single-arm trials are commonly included in regulatory approval submissions. Because of the high risk of biases, results from single-arm trials require careful inte...

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Główni autorzy:	Doranne Thomassen, Satrajit Roychoudhury, Cecilie Delphin Amdal, Dries Reynders, Jammbe Z. Musoro, Willi Sauerbrei, Els Goetghebeur, Saskia le Cessie, SISAQOL-IMI Work Package 3
Format:	Artigo
Język:	Inglês
Wydane:	BMC 2024-11-01
Seria:	BMC Medical Research Methodology
Hasła przedmiotowe:	Patient-reported outcomes Single-arm trial Estimand Quality of life Oncology Repeated measurements
Dostęp online:	https://doi.org/10.1186/s12874-024-02408-x
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