Design and Analysis of Multinational Clinical Trials
Design and Analysis of Multinational Clinical Trials
复制标题
跨国临床试验的设计与分析
DOI：
10.1177/00928615980320s126
复制
发表时间：
1998
影响因子：
1.5
通讯作者：
S. Chow
中科院分区：
文献类型：
--
作者：
H. Ho;S. Chow
近年来，跨国多中心试验越来越受欢迎，用于评估不同国家临床结果的普遍性。随着国际协调会议（ICH）良好临床规范（GCP）的实施，多国试验已被包括美国食品和药物管理局在内的大多数监管机构广泛接受。然而，正如Suwelack和Weihrauch(1)所指出的，在跨国试验中经常遇到一些困难。这些困难主要是由于文化、医疗实践、监管要求和药物管理方面的差异造成的，对多国试验的完整性产生了负面影响。在本文中，建议在进行多国试验期间，识别、消除或控制可能发生的所有可能的偏倚和变异性原因（包括预期的或意外的），以确保多国试验的成功。关于多国试验的设计和分析的一些实际问题也被处理。
In recent years, multinational multicenter trials have become increasingly popular for evaluation of the generalizability of clinical results across different countries. With the implementation of the International Conference on Harmonization (ICH) Good Clinical Practice (GCP), multinational trials have become widely accepted by most regulatory agencies including the United States Food and Drug Administration. As indicated by Suwelack and Weihrauch (1), however, some difficulties are often encountered in multinational trials. These difficulties, which are primarily due to differences in culture, medical practice, regulatory requirements, and drug management have a negative impact on the integrity of the multinational trial. In this paper, it is suggested that all possible causes (both expected or unexpected) of bias and variability that may occur during the conduct of a multinational trial be identified, eliminated/removed, or controlled whenever possible to ensure the success of the multinational trial. Some practical issues regarding the design and analysis of a multinational trial are also addressed.