Chen Xiaoyuan, Lu Nelson, Nair Rajesh, Xu Yunling, Kang Cailian, Huang Qin, Li Ning, Chen Hongzhuan
Department of Pharmacology and Biostatistics, Shanghai JiaoTong University School of Medicine, Shanghai, China.
J Biopharm Stat. 2012 Sep;22(5):1001-18. doi: 10.1080/10543406.2012.701582.
Multiregional clinical trials provide the potential to make safe and effective medical products simultaneously available to patients globally. As regulatory decisions are always made in a local context, this poses huge regulatory challenges. In this article we propose two conditional decision rules that can be used for medical product approval by local regulatory agencies based on the results of a multiregional clinical trial. We also illustrate sample size planning for such trials.
多区域临床试验为全球患者同时提供安全有效的医疗产品提供了可能性。由于监管决策总是在当地背景下做出的，这带来了巨大的监管挑战。在本文中，我们提出了两条有条件的决策规则，当地监管机构可根据多区域临床试验的结果将其用于医疗产品的批准。我们还举例说明了此类试验的样本量规划。
