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

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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Main Authors: 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: Article
Language:English
Published: BMC 2024-11-01
Series:BMC Medical Research Methodology
Subjects:
Patient-reported outcomes
Single-arm trial
Estimand
Quality of life
Oncology
Repeated measurements
Online Access:https://doi.org/10.1186/s12874-024-02408-x
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https://doi.org/10.1186/s12874-024-02408-x

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