Statistical inference for clinical trials with binary responses when there is a shift in patient population

Yang L.-Y.; Chi Y.; Chow S.-C.

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Statistical inference for clinical trials with binary responses when there is a shift in patient population

机译：当患者群体发生变化时，具有二元反应的临床试验的统计推断

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In clinical research, it is not uncommon to modify a trial procedure and/or statistical methods of ongoing clinical trials through protocol amendments. A major modification to the study protocol could result in a shift in target patient population. In addition, frequent and significant modifications could lead to a totally different study that is unable to address the medical questions that the original study intended to answer. In this article, we propose a logistic regression model for statistical inference based on a binary study endpoint for trials with protocol amendments. Under the proposed method, sample size adjustment is also derived.

机译：在临床研究中，通过协议修改来修改正在进行的临床试验的试验程序和/或统计方法并不罕见。对研究方案的重大修改可能会导致目标患者群体发生变化。此外，频繁而重大的修改可能导致完全不同的研究，而该研究无法解决原始研究打算回答的医学问题。在本文中，我们提出了一种基于二元研究终点的用于统计推断的逻辑回归模型，用于进行方案修订的试验。在提出的方法下，还可以得出样本大小的调整。

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《Journal of biopharmaceutical statistics》 |2011年第3期|共16页
作者
Yang L.-Y.; Chi Y.; Chow S.-C.;
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正文语种 eng
中图分类药学;
关键词
Binary study endpoint; Protocol amendment; Sample size adjustment; Shift in target patient population;

机译：二元研究终点;方案修订;样本量调整;目标患者群体的转移;

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1. Statistical inference for clinical trials with binary responses when there is a shift in patient population [J] . Yang L.-Y., Chi Y., Chow S.-C. Journal of biopharmaceutical statistics . 2011,第3期

机译：当患者群体发生变化时，具有二元反应的临床试验的统计推断
2. Are patients in clinical trials representative of the general population? Dose intensity and toxicities associated with FE100C-D chemotherapy in a non-trial population of node positive breast cancer patients compared with PACS-01 trial group. [J] . Fraser J, Steele N, Al Zaman A, European journal of cancer: official journal for European Organization for Research and Treatment of Cancer (EORTC) [and] European Association for Cancer Research (EACR) . 2011,第2期

机译：临床试验中的患者能代表一般人群吗？与PACS-01试验组相比，非试验性淋巴结阳性乳腺癌患者的FE100C-D化疗相关的剂量强度和毒性。
3. Statistical Inference of Adaptive Designs with Binary Responses [J] . YANQING YI, XIKUI WANG Communications in Statistics . 2007,第5a8期

机译：具有二元响应的自适应设计的统计推断
4. DO CANCER CLINICAL TRIAL POPULATIONS TRULY REPRESENT CANCER PATIENTS? A COMPARISON OF OPEN CLINICAL TRIALS TO THE CANCER GENOME ATLAS [C] . NOPHARGEIFMAN, ATUL J.BUTTE Pacific Symposium on Biocomputing . 2016

机译：癌症临床试验群体真正代表癌症患者吗？对癌症基因组阿特拉斯公开临床试验的比较
5. Clinical Significance of Response Shift in a Spine Interventional Clinical Trial [D] . Carlson, Robin S. 2015

机译：脊柱介入临床试验中反应转移的临床意义
6. Bayesian Modeling and Inference for Nonignorably Missing Longitudinal Binary Response Data with Applications to HIV Prevention Trials [O] . Jing Wu, Joseph G. Ibrahim, Ming-Hui Chen, -1

机译：不可遗漏的纵向二元反应数据的贝叶斯建模与推断及其在HIV预防试验中的应用
7. Inference and sample size calculation for clinical trials with incomplete observations of paired binary outcomes [O] . Song Zhang, Jing Cao, Chul Ahn 2016

机译：对成对二元成果的不完全观察的临床试验的推理和样本量计算

Statistical inference for clinical trials with binary responses when there is a shift in patient population

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