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首页> 美国卫生研究院文献>Current Controlled Trials in Cardiovascular Medicine >Clinical trials in developing countries: Discussions at the 9th International Symposium on Long Term Clinical Trials London UK 19-20 June 2000
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Clinical trials in developing countries: Discussions at the 9th International Symposium on Long Term Clinical Trials London UK 19-20 June 2000

机译：发展中国家的临床试验：2000年6月19日至20日在英国伦敦举行的第九届国际长期临床试验国际研讨会上的讨论

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This symposium provided a useful forum for the discussion of issues relating to the design and conduct of clinical trials. There is a need for greater awareness of the complexity of modern day trials, in which a host of statistical, logistical, regulatory and ethical issues are involved. Issues discussed ranged from the effect of sample size on the outcome, and subgroup analysis, to defining and maintaining discrete endpoints. Some useful debate centred on the use of meta-analysis and the current limitations of combining information from different data sets. This brought up the subjects of trial registries and raw data repositories for all clinical trials. Progress and relevance of the Cochrane collaboration were reviewed. The economics of clinical trials was another important topic. Regulatory issues such as the role of data and safety monitoring boards (DSMB) and the guidelines in place for effective data monitoring and progress analysis were discussed. Representatives of government organisations and industry gave both European and American perspectives. This report however focuses specifically on the section devoted to the subject of clinical trials in developing countries.
机译：该研讨会为讨论与临床试验的设计和进行有关的问题提供了一个有用的论坛。有必要进一步提高对现代审判的复杂性的认识，其中涉及许多统计，后勤，监管和道德问题。讨论的问题范围从样本量对结果的影响，亚组分析到定义和维护离散的终点。一些有用的辩论集中在荟萃分析的使用以及合并来自不同数据集的信息的当前限制上。这就提出了所有临床试验的试验注册和原始数据存储库的主题。评估了Cochrane合作的进展和相关性。临床试验的经济学是另一个重要的话题。讨论了法规问题，例如数据和安全监视委员会（DSMB）的作用以及有效的数据监视和进度分析的适当指南。政府组织和行业的代表都发表了欧洲和美国的观点。但是，本报告特别侧重于发展中国家的临床试验主题。

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