Optimal sample size allocation and go/no‐go decision rules for phase II/III programs where several phase III trials are performed

Preussler Stella; Kieser Meinhard; Kirchner Marietta

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Optimal sample size allocation and go/no‐go decision rules for phase II/III programs where several phase III trials are performed

机译：阶段II / III计划的最佳样本大小分配和GO / NO-GO决策规则进行了几阶段III试验

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来源
《Biometrical Journal》 |2019年第2期|共22页
作者
Preussler Stella; Kieser Meinhard; Kirchner Marietta;
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作者单位

Institute of Medical Biometry and InformaticsUniversity of HeidelbergHeidelberg Germany;

Institute of Medical Biometry and InformaticsUniversity of HeidelbergHeidelberg Germany;

Institute of Medical Biometry and InformaticsUniversity of HeidelbergHeidelberg Germany;

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原文格式 PDF
正文语种 eng
中图分类生物学实验与观测;
关键词
drug development program; optimization; phase II/III; probability of success; sample size;

机译：药物发展计划;优化;第II期/ III;成功的概率;样品大小;

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专利

1. Optimal sample size allocation and go/no‐go decision rules for phase II/III programs where several phase III trials are performed [J] . Preussler Stella, Kieser Meinhard, Kirchner Marietta Biometrical Journal . 2019,第2期

机译：阶段II / III计划的最佳样本大小分配和GO / NO-GO决策规则进行了几阶段III试验
2. Intermediate Monitoring, Sample Size Reassessment, and Multi-Treatment Optimal Response-Adaptive Designs for Phase III Clinical Trials with More Than One Constraint [J] . ATANU BISWAS, PINAKPANI PAL Communications in Statistics . 2009,第6a7期

机译：具有多个约束的III期临床试验的中间监测，样本量重新评估和多治疗最佳反应适应性设计
3. Intermediate Monitoring, Sample Size Reassessment, and Multi-Treatment Optimal Response-Adaptive Designs for Phase III Clinical Trials with More Than One Constraint [J] . Atanu Biswas Communications in Statistics - Simulation and Computation . 2009,第6期

机译：具有多个约束的III期临床试验的中间监测，样本量重新评估和多治疗最佳反应适应性设计
4. Statistical Methods for Combining Clinical Trial Phases II And III [C] . Nigel Stallard, Susan Todd International Conference on Statistics in Health Sciences . 2007

机译：结合临床试验阶段II和III的统计方法
5. Examination of novel statistical designs for phase II and phase III clinical trials. [D] . Ayanlowo, Ayanbola Olajumoke. 2007

机译：检验II期和III期临床试验的新颖统计设计。
6. Optimal designs for phase II/III drug development programs including methods for discounting of phase II results [O] . Stella Erdmann, Marietta Kirchner, Heiko Götte, 2020

机译：II / III阶段药物开发计划的最佳设计包括贴现第二阶段结果的方法
7. Correction to: Optimal Decision Criteria for the Study Design and Sample Size of a Biomarker‑Driven Phase III Trial [O] . Akira Takazawa, Satoshi Morita 2020

机译：纠正：生物标志物驱动阶段试验的研究设计和样本量的最佳决策标准

Optimal sample size allocation and go/no‐go decision rules for phase II/III programs where several phase III trials are performed

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