| 临床试验中贝叶斯自适应随机化的介绍与评价 |
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| 引用本文： | 陈冬,夏结来,蒋志伟,王永吉.临床试验中贝叶斯自适应随机化的介绍与评价[J].中国新药杂志,2012(7):706-709. |
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| 作者姓名： | 陈冬 夏结来 蒋志伟 王永吉 |
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| 作者单位： | 第四军医大学预防医学系卫生统计学教研室;中国人民解放军第309医院医务部 |
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| 基金项目： | 国家自然科学基金(81072390) |
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| 摘 要： | 目前,在我国新药临床试验中,随机化是进行临床试验的规范程序,现在通用的随机化方法是1∶1均衡性随机,这样做的好处是在相同样本含量前提下可以获得较大的检验效能,并且从伦理学上来考虑,由于不能及时的根据已获得的处理结果,提早的判别何为较优疗效,重新调整分组概率,使得后续受试者面临额外的接受较劣疗效处理的风险。本文介绍一种基于贝叶斯的自适应随机化方法,以便解决上述问题。
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| 关 键 词： | 贝叶斯 自适应 随机化 |
Introduction and evaluation of Bayesian adaptive randomization in clinical trials |
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| CHEN Dong,XIA Jie-lai,JIANG Zhi-wei,WANG Yong-ji.Introduction and evaluation of Bayesian adaptive randomization in clinical trials[J].Chinese Journal of New Drugs,2012(7):706-709. |
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| Authors: | CHEN Dong XIA Jie-lai JIANG Zhi-wei WANG Yong-ji |
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| Institution: | 1 Department of Health Statistics,Faculty of Preventive Medicine,The Fourth Military Medical University, Xi’an 710032,China;2 Department of Medical Administration,The 309 Hospital of PLA,Beijing 100091,China) |
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| Abstract: | Randomization is the standard procedure in clinical trials and the equal randomization is a common method with the advantage of the biggest power.Furthermore the equal randomization can not use the accumulating knowledge in the accrual of trial to determine which treatment is better or the trial should be stopped early.The ethics in clinical trials can not accept the randomization that makes the subjects facing the additional risk by worse effect.This paper presented a Bayesian adaptive randomization method to solve these problems. |
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| Keywords: | Bayesian adaptive design randomization |
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