Investigating the trends in patient-reported outcomes pre-treatment and implications to efficacy analyses: A post-hoc analysis of a cancer clinical trial.

Michael Schlichting,Hector Sanz,Paul Williams,Nicolas Ballarini,Gerd Rippin,Vivek Pawar

Contemporary clinical trials communications（2022）

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摘要

Findings from this study question the need for multiple pre-treatment PRO assessments in oncology drug development trials and the degree of bias thought to be introduced through patient knowledge of treatment assignment. Implications for researchers are presented.

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关键词

Assessment time bias,Baseline,Clinical trial design,Health-related quality of life,Lung cancer,Patient-reported outcomes

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