The comparison of two strategies for China as a center in multi⁃regional twin clinical studies
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    Abstract:

    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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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(自然科学版英文版),2019,(2):295-299.

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History
  • Received:September 29,2018
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  • Online: March 06,2019
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