The pharmaceutical industry and regulatory agencies are increasingly interested in conducting bridging studies in order to bring an approved drug product from the original region (e.g., United States or European Union) to a new region (e.g., Asian-Pacific countries). In this paper, we provide a new methodology for the design and analysis of bridging studies by assuming prior knowledge on how the null and alternative hypotheses in the original, foreign study are related to the null and alternative hypotheses in the bridging study and setting the type I error for the bridging study according to the strength of the foreign-study evidence. The new methodology accounts for randomness in the foreign-study evidence and controls the average type I error of the bridging study over all possibilities of the foreign-study evidence. In addition, the new methodology increases statistical power, when compared to approaches that do not use foreign-study evidence, and it allows for the possibility of not conducting the bridging study when the foreign-study evidence is unfavorable. Finally, we conducted extensive simulation studies to demonstrate the usefulness of the proposed methodology. This article is protected by copyright. All rights reserved.

中文翻译：

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使用原假设和替代假设的先验概率进行桥接研究的设计和分析

制药行业和监管机构越来越有兴趣进行桥接研究，以便将批准的药品从原始地区（例如，美国或欧盟）带到新的地区（例如，亚太国家）。在本文中，我们通过假设有关原始外国研究中的原假设和备择假设如何与桥接研究中的原假设和备择假设相关的先验知识，并设置类型，为桥接研究的设计和分析提供了一种新方法根据国外研究证据的强度，我错误地进行了桥接研究。新方法考虑了国外研究证据的随机性，并控制了桥接研究对国外研究证据的所有可能性的平均 I 类错误。此外，与不使用国外研究证据的方法相比，新方法提高了统计能力，并且允许在国外研究证据不利时不进行桥接研究的可能性。最后，我们进行了广泛的模拟研究，以证明所提出方法的有效性。本文受版权保护。版权所有。