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Challenges from Variation across Regions in Cost Effectiveness Analysis in Multi-Regional Clinical Trials

机译:跨地区临床试验成本效益分析中来自地区差异的挑战

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Economic evaluation in the form of cost-effectiveness analysis has become a popular means to inform decisions in healthcare. With multi-regional clinical trials in a global development program becoming a new venue for drug efficacy testing in recent decades, questions in methods for cost-effectiveness analysis in the multi-regional clinical trials setting also emerge. This paper addresses some challenges from variation across regions in cost effectiveness analysis in multi-regional clinical trials. Several discussion points are raised for further attention and a multi-regional clinical trial example is presented to illustrate the implications in industrial application. A general message is delivered to call for a depth discussion by all stakeholders to reach an agreement on a good practice in cost-effectiveness analysis in the multi-regional clinical trials. Meanwhile, we recommend an additional consideration of cost-effectiveness analysis results based on the clinical evidence from a certain homogeneous population as sensitivity or scenario analysis upon data availability.
机译:成本效益分析形式的经济评估已成为在医疗保健领域提供决策依据的一种流行手段。近几十年来,随着全球开发计划中的多区域临床试验成为药物功效测试的新场所,在多区域临床试验环境中进行成本效益分析的方法也出现了问题。本文解决了多区域临床试验中成本效益分析中跨区域差异带来的一些挑战。提出了几个讨论点,以引起更多关注,并提供了一个多区域临床试验示例来说明其在工业应用中的含义。传达了一条总体信息,要求所有利益相关者进行深入讨论,以就多区域临床试验中成本效益分析的良好实践达成协议。同时,我们建议根据来自某些同质人群的临床证据,另外考虑成本效益分析结果,作为对数据可用性的敏感性或情景分析。

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