文章摘要
石晓东,成 岗,戴鲁燕,陈 峰.中国参与国际多中心双胞胎试验两种策略比较[J].南京医科大学学报,2019,(2):295~299
中国参与国际多中心双胞胎试验两种策略比较
The comparison of two strategies for China as a center in multi⁃regional twin clinical studies
投稿时间:2018-09-29  
DOI:10.7655/NYDXBNS20190230
中文关键词: 临床试验  国际多中心  双胞胎试验  一致性概率
英文关键词: clinical trial  MRCT  twin studies  consistency probability
基金项目:
作者单位
石晓东 南京医科大学公共卫生学院江苏 南京 211166勃林格殷格翰(中国)投资有限公司上海 200040 
成 岗 勃林格殷格翰(中国)投资有限公司上海 200040 
戴鲁燕 和铂医药上海 201203 
陈 峰 南京医科大学公共卫生学院江苏 南京 211166 
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中文摘要:
      目的:国际多中心临床试验(multi?regional clinical trials,MRCT)越来越多被各国药监机构所接受,为评价试验结果的稳健性,美国食品药品监督管理局(FDA)在某些治疗领域要求制药企业开展两个相同的国际多中心试验(又称双胞胎试验),以确保试验结果的可重复性。本研究旨在评价中国以两种典型的策略加入国际多中心双胞胎临床试验的统计学效能。方法:采用统计学模拟试验的方法,比较两种策略的统计学性质,以及中国人群与整体人群在疗效上的一致性概率。结果:两种策略下按照标准1和标准2计算出的一致性概率来看,并且仅考虑一致性概率的情况下,策略A优策略B。结论:给出了在不同情况下两种策略的优势与劣势,并提供了相应策略。
英文摘要:
      Objective:Multi?regional Clinical Trials(MRCTs)are more widely accepted by regulatory authorities from different countries to evaluate the robustness of clinical trial results. FDA requires pharmaceutical companies to conduct two identical multi?regional clinical trials in some therapeutical areas,which is named as twin studies,to ensure that the trials results are repeatable. The paper evaluates two strategies for China to participate MRCT in case twin studies are required. Methods:Data simulation is performed to evaluate these two strategies,and further assess the consistency in efficacy between China and overall population. Results:Accordind to the consistency probabilinies calculate by standard 1 and standard 2,the strategy A is better than the strategy B in the two strategies. Conclusion:Strength and weakness of two strategies are illustrated under different scenarios,and provides corresponding solution and recommendation.
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