Current Status and Open Issues Concerning Global Clinical Trials (GCTs) in Japan and East Asia. 2017

Koichi Miyazaki, and Yasunori Sato, and Hideki Hanaoka, and Yoshiaki Uyama
Asia Development Department, Daiichi Sankyo Co. Ltd., Tokyo, Japan.

When global clinical trials are carried out, it is important to consider the influence of racial and ethnic differences on the outcome. From this viewpoint, global clinical trials in East Asia, where racial differences are estimated to be small, are now attracting close attention. Under such circumstances, we conducted a survey using the data registered with ClinicalTrial.gov to investigate the status of participation of East Asian countries in global clinical trials and differences in the regions selected for drug development between Japanese enterprises and non-Japanese enterprises. This survey revealed that about 90% of all global clinical trials and those involving East Asian countries were sponsored by non-Japanese enterprises. Global clinical trials involving only East Asia have been accepted as one of the development strategies by Japanese enterprises, but this strategy has not spread widely among non-Japanese enterprises.

UI MeSH Term Description Entries
D007564 Japan A country in eastern Asia, island chain between the North Pacific Ocean and the Sea of Japan, east of the Korean Peninsula. The capital is Tokyo. Bonin Islands
D002986 Clinical Trials as Topic Works about pre-planned studies of the safety, efficacy, or optimum dosage schedule (if appropriate) of one or more diagnostic, therapeutic, or prophylactic drugs, devices, or techniques selected according to predetermined criteria of eligibility and observed for predefined evidence of favorable and unfavorable effects. This concept includes clinical trials conducted both in the U.S. and in other countries. Clinical Trial as Topic
D005202 Asia, Eastern A geographic area of east and southeast Asia encompassing CHINA; HONG KONG; JAPAN; KOREA; MACAO; MONGOLIA; and TAIWAN. East Asia,Far East,Eastern Asia
D006801 Humans Members of the species Homo sapiens. Homo sapiens,Man (Taxonomy),Human,Man, Modern,Modern Man
D013997 Time Factors Elements of limited time intervals, contributing to particular results or situations. Time Series,Factor, Time,Time Factor
D038622 Internationality The quality or state of relating to or affecting two or more nations. (After Merriam-Webster Collegiate Dictionary, 10th ed) Globalization,International Aspects,International Perspectives,International Relations,Multinational Aspects,Multinational Perspectives,Aspect, International,Aspect, Multinational,Aspects, International,Aspects, Multinational,International Aspect,International Perspective,Multinational Aspect,Multinational Perspective,Perspective, International,Perspective, Multinational,Perspectives, International,Perspectives, Multinational,Relations, International

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