Clinical Trials and the New Good Clinical Practice Guideline in JapanAn Economic Perspective

被引：0
|
作者：
Shunsuke Ono
Yasuo Kodama
机构：
[1] National Institute of Health Sciences,Pharmaceuticals and Medical Devices Evaluation Center
[2] Ministry of Health and Welfare,Review and Audit Division, Clinical Trial Guidance Department
[3] The Organisation for Pharmaceutical Safety and Research,undefined
来源：
PharmacoEconomics | 2000年 / 18卷
关键词：
European Union; Japanese Patient; Guideline Implementation; Clinical Trial Setting; Universal Health Insurance;
D O I：
暂无
中图分类号：
学科分类号：
摘要：
Japanese clinical trials have been drastically changing in response to the implementation of the International Conference on Harmonisation — Good Clinical Practice (ICH-GCP) guideline in 1997. The most important aim of the new guideline is to standardise the quality of clinical trials in the US, European Union and Japan, but it inevitably imposes substantial costs on investigators, sponsors and even patients in Japan.
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页码：125 / 141
页数：16
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