The contemporary situation for the conduct of clinical trials in Asia

被引:0
|
作者
Fenn C.G. [1 ]
Wong E. [1 ]
Zambrano D. [1 ]
机构
[1] Area Medical Director, Australia/SE Asia, Pharmacia, Sydney, NSW
来源
关键词
Asia; Bridging study; Clinical trials; Good clinical practice; ICH guidelines;
D O I
10.1097/00124363-200108000-00003
中图分类号
学科分类号
摘要
The conduct of clinical trials in Asia is a rapidly evolving process. Herein, we attempt to outline the current status of good clinical practice (GCP) standards and regulatory requirements in the region (excluding China and Japan). These vary significantly making some countries more attractive than others for the conduct of global studies. Government bodies and the pharmaceutical industry can both contribute to the continued improvements in standards of trial conduct. There are significant clinical opportunities for studying diseases more prevalent in this region than elsewhere. Furthermore, major benefits can accrue from conducting studies in the region, to companies, to investigators, to physicians and most importantly to patients in the local population.
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页码:169 / 173
页数:4
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