Bridging Studies in Japan and Taiwan: A Dynamic Evolution in Regulating Ethnic Differences
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Bridging Studies in Japan and Taiwan: A Dynamic Evolution in Regulating Ethnic Differences In the past 10years since the implementation of the E5 guideline, bridging studies have been one of the most contmersialICH conceptsfor East Asian states. This article reveals the dynamics of bridging studies by comprehensively reviewing their evdution and pdicy impacts in Japan and Taiwan @ a compamtive perspective. This artide addmses the fdowing. First, the concept of bridging d i e s has proved to be a diplo3natic -tion a m’entific consensus. Nth& it facilitated the making of the E5 guideline, it Zejl the probZem ofpuftingit
Wen-Huo Kuo, MD, PhD Associate Professor. Center for Humanities and Social Scienceandlnstituteof Public Health, National Yang-Ming University. Taipei, Taiwan
Key Words ICH; E5 guideline; Bridging study; Global drug development
Correspondence Address Dr. Wen-Hua Kuo. Center for Humanities and Social Science. National YangMing University, No. 155, Sec. 2, Linong Street, Taipei 112. Taiwan (email: whho @ym.edu.t w) .
I N T R O DUCT1 0 N In the past 10years since the implementation of the E5 guideline, bridging has been one of the most influential and perhaps controversial concepts for East Asian states (1). Each regulatory authority merits its own interpretation of ethnic differences and of the function of bridging studies when used in estimating those differences. As a result, the requirements for assessing a tested drug’s ethnic effects vary from one market to another, confounding those who seek to waive redundant local trials. Meanwhile,clinical trials are increasingly outsourced to Asia where, compared to those done in the United States, quality-acceptable clinical data can be generated at less cost. Although this trend is welcomed by pharmaceutical producers and those who consider translational medicine a promising business, it does warrant caution. The applicability of these data, which are mainly derived from Asian subjects, is scientifically uncertain unless appropriate evaluations are performed on their ethnic characteristics. Thus, a bridging study is key to understanding the Asian markets and the strategies for doing clinical trials in this region. From a comparative perspective, this article
into pmctice. second, Jqprm did not whaleheurted!vd u m e bridging siudies; it believed that a tnmsition to spontaneous global trials d d soon fdaw and exhausted its ngulatory meuns to pursue it. Thint, Taiwan capturcd this contnnmial concept as an ICH outsida; and shawed thc ICH the feusibiZity of bridgingstudies. It jidw attempted to extend theirfm’bility to create a nnatistatc trial scheme, thereby rucping its visibility to the ICH. In addition, based on thesefidings, this artide provides a regulatory odd on pmt-Asian dinid trial schemes.
reveals the dynamics of bridging studies from their creation and implementation to their policy impacts in Japan and Taiwan, whose populations are relatively similar in racial composition yet whose governments’ stances toward regulating ethnic effects in phar
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