General view of clinical trials and gcp in east asia

被引：0

作者：

Tsutani K. ^{[1
]}

机构：

[1] Department of Clinical Pharmacology, Division of Information Medicine, Medical Research Institute, Tokyo Medical and Dental University, Tokyo 101, 2-3-10, Kanda-Surugadai, Chiyoda-ku

来源：

Drug information journal : DIJ / Drug Information Association | 1997年 / 31卷 / 4期

关键词：

Clinical trials; East Asia; Good Clinical Practice; International Conference for Harmonization;

D O I：

10.1177/009286159703100402

中图分类号：

学科分类号：

摘要：

This paper presents the background to the DIA Workshop “Clinical Trials and GCP in East Asia,” in which experts from China, Japan, Republic of Korea, Singapore, and Taiwan participated. Common features and differences among these five countries are discussed. A brief historical review of Good Clinical Practice (GCP) is provided, including some recent developments in the region. Some recent forums in Asia relating to clinical trials and GCP are introduced and ethical issues involved in clinical trials are addressed from the socio-cultural context, particularly the different ethical principles in the East Asian region and the West. Cross-national ethics in the use of foreign clinical trial data are also addressed. © 1997, Drug Information Association. All rights reserved.

引用

页码：1057 / 1064

页数：7