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Conditional bias adjusted estimator of treatment effect in 2-in-1 adaptive design.
Bai, Xiaofei; Deng, Qiqi; Li, Wen.
Afiliação
  • Bai X; Biometrics, Servier Bio-Innovation LLC, Boston, Massachusetts, USA.
  • Deng Q; Biostatistics, Moderna Inc, Cambridge, Massachusetts, USA.
  • Li W; Vaccine Clinical Research & Development, Pfizer, Inc, Collegeville, Pennsylvania, USA.
J Biopharm Stat ; : 1-20, 2024 Jun 06.
Article em En | MEDLINE | ID: mdl-38841980
ABSTRACT
For implementation of adaptive design, the adjustment of bias in treatment effect estimation becomes an increasingly important topic in recent years. While adaptive design literature traditionally focuses on the control of type I error rate and the adjustment of overall unconditional bias, the research on adjusting conditional bias has been limited. This paper proposes a conditional bias adjustment estimator of treatment effect under the context of 2-in-1 adaptive design and aims to provide a comprehensive investigation on their statistical properties including bias, mean squared error and coverage probability of confidence intervals. It demonstrated that conditional bias adjusted estimators greatly reduce the conditional bias and have similarly negligible unconditional bias compared with mean and median (unconditional) unbiased estimators. In addition, the test statistics is constructed based on the conditional bias adjustment estimators and compared with the naive unadjusted test.
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Texto completo: 1 Base de dados: MEDLINE Idioma: En Ano de publicação: 2024 Tipo de documento: Article

Texto completo: 1 Base de dados: MEDLINE Idioma: En Ano de publicação: 2024 Tipo de documento: Article