General View of Clinical Trials and GCP in East Asia

Abstract

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.