随机分配簿:实现临床试验随机分配遮蔽的新技术

发布时间：2018-01-21 14:10

本文关键词： 随机对照临床试验随机分配分配遮蔽信封法两联单　出处：《医学研究生学报》2017年01期 　论文类型：期刊论文

【摘要】：目的随机分配遮蔽对保证高质量的随机对照临床试验(RCT)具有重要意义。文中通过对信封法随机分配遮蔽技术的改进,以期设计一种更为便捷、有效的两联单随机分配遮蔽方法。方法根据产生的随机分配序列,为每一受试者制作一份随机分配两联单,并按顺序装订成册,制作成带有封面和使用说明的随机分配簿。两联单的第一联为说明联,第二联为分配联,两联序号相同、四周密封胶联,并在两联的相同区域处留空用于签署受试者信息。第一联书写的内容可完全复写至第二联上;第二联分配信息的背面涂黑印刷,避免透光识别而导致分配信息的提前破解。当研究者确定受试者合格后,依先后顺序选择受试者对应的两联单。在第一联签署受试者信息后沿周边撕开暴露第二联分配信息,并将该受试者分配至第二联上所指定的组别。随机分配薄可委托专业印刷机构。按照随机分配序列表,并在严格的质量控制下印刷制作,对于多中心临床试验可分中心独立印制。结果该方法已在18项临床试验中得到应用,其中5项为多中心试验,3项为产品注册试验。结论两联单随机分配簿方法制作容易、操作简单、监查方便,可有效实现临床试验随机分配遮蔽,对确保随机化质量具有较强的实用价值。
[Abstract]:Objective to improve the random distribution masking technique of envelope method in order to design a more convenient way to ensure the high quality of RCTs in randomized controlled clinical trials. Method according to the generated random distribution sequence, we make a random allocation list for each subject, and bind it into a book in order. A random distribution book with cover and usage instructions is made. The first of the two binders is the explanatory one and the second is the distribution joint, with the same serial number and four sealants. The contents of the first copy can be completely duplicated to the second one. The second distribution information is blackened on the back to avoid light transmission recognition resulting in early interpretation of the distribution information when the researcher determines that the subjects are qualified. The subjects were selected in sequence for the two combinations. The second distribution information was exposed along the periphery after the first copy signed the subject information. The subjects were assigned to the group designated on the second set. The random distribution book could be entrusted to the professional printing organization. According to the random distribution sequence list, the subject could be printed under strict quality control. Results the method has been used in 18 clinical trials, 5 of which are multicenter trials. Conclusion the double single random distribution book method is easy to make, easy to operate and easy to monitor, and can effectively realize random distribution masking in clinical trials. It has strong practical value to ensure the quality of randomization.
【作者单位】：南方医科大学金陵医院(南京军区南京总医院)医务部;南京军区南京总医院国家肾脏疾病临床医学研究中心全军肾脏病研究所;
【基金】：国家自然科学基金(81473066)
【分类号】：R969.4
【正文快照】： 0引言在随机对照临床试验中,无论是临床研究者还是受试对象,一旦事先知晓了被分配的组别,都可能会因为个人的主观因素潜在地或有意识地破坏随机分配,进而影响整个临床试验的质量[1-2]。2016年国家食品药品监督管理总局发布的《药物临床试验的生物统计学指导原则》中指出,随机

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