The necessary conduct: Exploratory multiregional clinical trials in East Asia

Abstract Various studies have highlighted the importance of ethnic differences. The consideration of ethnic differences in the field of individualized pharmacotherapy is imperative. Therefore, various organizations and networks across countries should aim to conduct multicountry and multiregional cl...

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Autores principales:	Inseung Jeon, Yu Kyong Kim, Ildae Song, Deok Yong Yoon, Ki Young Huh, Xuanyou Jin, Kyung‐Sang Yu, SeungHwan Lee, Yuji Kumagai, In‐Jin Jang
Formato:	article
Lenguaje:	EN
Publicado:	Wiley 2021
Materias:	Therapeutics. Pharmacology RM1-950 Public aspects of medicine RA1-1270
Acceso en línea:	https://doaj.org/article/e44104f2181d4e1498d77aec00a35158
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spelling	oai:doaj.org-article:e44104f2181d4e1498d77aec00a351582021-11-19T17:51:35ZThe necessary conduct: Exploratory multiregional clinical trials in East Asia1752-80621752-805410.1111/cts.13106https://doaj.org/article/e44104f2181d4e1498d77aec00a351582021-11-01T00:00:00Zhttps://doi.org/10.1111/cts.13106https://doaj.org/toc/1752-8054https://doaj.org/toc/1752-8062Abstract Various studies have highlighted the importance of ethnic differences. The consideration of ethnic differences in the field of individualized pharmacotherapy is imperative. Therefore, various organizations and networks across countries should aim to conduct multicountry and multiregional clinical trials (MRCTs). If there is solid evidence available to evaluate the existence of ethnic differences between the same regional areas, it will lead to an increase in the efficiency of drug development. The purpose of this paper was to compare the approval dosing regimen among four Asian countries (Korea, Japan, China, and Taiwan) and elucidate the readiness and current status of the implementation of the International Conference on Harmonization (ICH) E17 guidelines on MRCTs. Reducing unnecessary clinical trials via multinational clinical trials in East Asian countries is also suggested. The approved dosing regimens for some drugs in the four Asian countries were similar; however, some differences might be caused by differences in legislation, even though there were no ethnic differences. This indicates that there are several roles to be expected of the Asia Clinical Pharmacology study network for exploratory MRCTs, which would lead to the accumulation of evidence for MRCTs, ultimately accelerating the efficiency of drug development in East Asian countries. The exposure of the new treatment to the necessary patients through collaborative research coordination and simultaneous multinational subject recruitment would serve its role in providing East Asia with specific personalized medicine with a high treatment success rate.Inseung JeonYu Kyong KimIldae SongDeok Yong YoonKi Young HuhXuanyou JinKyung‐Sang YuSeungHwan LeeYuji KumagaiIn‐Jin JangWileyarticleTherapeutics. PharmacologyRM1-950Public aspects of medicineRA1-1270ENClinical and Translational Science, Vol 14, Iss 6, Pp 2399-2407 (2021)
institution	DOAJ
collection	DOAJ
language	EN
topic	Therapeutics. Pharmacology RM1-950 Public aspects of medicine RA1-1270
spellingShingle	Therapeutics. Pharmacology RM1-950 Public aspects of medicine RA1-1270 Inseung Jeon Yu Kyong Kim Ildae Song Deok Yong Yoon Ki Young Huh Xuanyou Jin Kyung‐Sang Yu SeungHwan Lee Yuji Kumagai In‐Jin Jang The necessary conduct: Exploratory multiregional clinical trials in East Asia
description	Abstract Various studies have highlighted the importance of ethnic differences. The consideration of ethnic differences in the field of individualized pharmacotherapy is imperative. Therefore, various organizations and networks across countries should aim to conduct multicountry and multiregional clinical trials (MRCTs). If there is solid evidence available to evaluate the existence of ethnic differences between the same regional areas, it will lead to an increase in the efficiency of drug development. The purpose of this paper was to compare the approval dosing regimen among four Asian countries (Korea, Japan, China, and Taiwan) and elucidate the readiness and current status of the implementation of the International Conference on Harmonization (ICH) E17 guidelines on MRCTs. Reducing unnecessary clinical trials via multinational clinical trials in East Asian countries is also suggested. The approved dosing regimens for some drugs in the four Asian countries were similar; however, some differences might be caused by differences in legislation, even though there were no ethnic differences. This indicates that there are several roles to be expected of the Asia Clinical Pharmacology study network for exploratory MRCTs, which would lead to the accumulation of evidence for MRCTs, ultimately accelerating the efficiency of drug development in East Asian countries. The exposure of the new treatment to the necessary patients through collaborative research coordination and simultaneous multinational subject recruitment would serve its role in providing East Asia with specific personalized medicine with a high treatment success rate.
format	article
author	Inseung Jeon Yu Kyong Kim Ildae Song Deok Yong Yoon Ki Young Huh Xuanyou Jin Kyung‐Sang Yu SeungHwan Lee Yuji Kumagai In‐Jin Jang
author_facet	Inseung Jeon Yu Kyong Kim Ildae Song Deok Yong Yoon Ki Young Huh Xuanyou Jin Kyung‐Sang Yu SeungHwan Lee Yuji Kumagai In‐Jin Jang
author_sort	Inseung Jeon
title	The necessary conduct: Exploratory multiregional clinical trials in East Asia
title_short	The necessary conduct: Exploratory multiregional clinical trials in East Asia
title_full	The necessary conduct: Exploratory multiregional clinical trials in East Asia
title_fullStr	The necessary conduct: Exploratory multiregional clinical trials in East Asia
title_full_unstemmed	The necessary conduct: Exploratory multiregional clinical trials in East Asia
title_sort	necessary conduct: exploratory multiregional clinical trials in east asia
publisher	Wiley
publishDate	2021
url	https://doaj.org/article/e44104f2181d4e1498d77aec00a35158
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The necessary conduct: Exploratory multiregional clinical trials in East Asia

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