{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2025,5,14]],"date-time":"2025-05-14T00:43:06Z","timestamp":1747183386245,"version":"3.40.5"},"reference-count":19,"publisher":"Wiley","issue":"6","license":[{"start":{"date-parts":[[2019,3,28]],"date-time":"2019-03-28T00:00:00Z","timestamp":1553731200000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Brit J Clinical Pharma"],"published-print":{"date-parts":[[2019,6]]},"abstract":"<jats:sec><jats:title>Aims<\/jats:title><jats:p>This study aimed to identify population\/regional differences in drug efficacy and the influencing factors among East Asians to be considered when planning multiregional clinical trials (MRCTs) to facilitate rapid drug approval in Asians.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>A retrospective analysis of efficacy (intergroup difference in endpoint between control and study drug treatment) among East Asian populations for 3 drug categories, antidiabetic, respiratory and psychotropic agents, was conducted in collaboration with pharmaceutical companies using their MRCT data. Common endpoints by drug category were selected; background factors that commonly affected the endpoints among regions were analysed first; then the population\/regional differences were evaluated by the interaction term <jats:italic>region\u2010by\u2010treatment<\/jats:italic> using an analysis of covariance model after adjusting for background factors.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>Among 17 endpoints for eight pharmaceutical products from 3 drug categories, no substantial population\/regional differences were detected in the 3 drug categories examined (<jats:italic>P<\/jats:italic>\u00a0&gt;\u00a0.05), except for haemoglobin A1c change between Japan and Korea for an antidiabetic drug, insulin glulisine (<jats:italic>P<\/jats:italic>\u00a0=\u00a0.0068). However, no such regional differences were evident in patients with clinically important higher haemoglobin A1c baseline values (majority subgroup). Variability in disease severity at baseline and concomitant drugs were determined to be potential influencing factors for regional differences.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusions<\/jats:title><jats:p>This study suggests that the regional variability in efficacy of these 3 drug categories is not large among East Asians, and reveals the importance of considering background factors when planning MRCTs. Further studies are needed to evaluate regional variability in the efficacy of other drug categories and clarify the factors leading to regional differences in East Asians.<\/jats:p><\/jats:sec>","DOI":"10.1111\/bcp.13893","type":"journal-article","created":{"date-parts":[[2019,2,8]],"date-time":"2019-02-08T19:28:52Z","timestamp":1549654132000},"page":"1270-1282","source":"Crossref","is-referenced-by-count":3,"title":["Population\/regional differences in efficacy of 3 drug categories (antidiabetic, respiratory and psychotropic agents) among East Asians: A retrospective study based on multiregional clinical trials"],"prefix":"10.1111","volume":"85","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-1586-6515","authenticated-orcid":false,"given":"Kimie","family":"Sai","sequence":"first","affiliation":[{"name":"Division of Medicinal Safety Science National Institute of Health Sciences  Kawasaki Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Akiomi","family":"Yoshida","sequence":"additional","affiliation":[{"name":"Department of Clinical Medicine (Biostatistics), School of Pharmacy Kitasato University  Tokyo Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Tadaaki","family":"Hanatani","sequence":"additional","affiliation":[{"name":"Division of Medicinal Safety Science National Institute of Health Sciences  Kawasaki Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-8160-7335","authenticated-orcid":false,"given":"Takuya","family":"Imatoh","sequence":"additional","affiliation":[{"name":"Division of Medicinal Safety Science National Institute of Health Sciences  Kawasaki Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Masahiro","family":"Takeuchi","sequence":"additional","affiliation":[{"name":"Department of Clinical Medicine (Biostatistics), School of Pharmacy Kitasato University  Tokyo Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Mamoru","family":"Narukawa","sequence":"additional","affiliation":[{"name":"Department of Clinical Medicine (Pharmaceutical Medicine), School of Pharmacy Kitasato University  Tokyo Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Hiroshi","family":"Watanabe","sequence":"additional","affiliation":[{"name":"Department of Clinical Pharmacology and Therapeutics Hamamatsu University School of Medicine  Hamamatsu Japan"},{"name":"Center of Clinical Sciences National Center for Global Health and Medicine  Tokyo Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Yoshiaki","family":"Uyama","sequence":"additional","affiliation":[{"name":"Office of Medical Informatics and Epidemiology Pharmaceuticals &amp; Medical Devices Agency  Tokyo Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Yoshiro","family":"Saito","sequence":"additional","affiliation":[{"name":"Division of Medicinal Safety Science National Institute of Health Sciences  Kawasaki Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"311","published-online":{"date-parts":[[2019,3,28]]},"reference":[{"key":"e_1_2_10_2_1","doi-asserted-by":"publisher","DOI":"10.1038\/clpt.2009.285"},{"key":"e_1_2_10_3_1","doi-asserted-by":"publisher","DOI":"10.1080\/10543406.2012.701581"},{"key":"e_1_2_10_4_1","doi-asserted-by":"publisher","DOI":"10.1038\/clpt.2013.106"},{"key":"e_1_2_10_5_1","doi-asserted-by":"publisher","DOI":"10.1038\/clpt.2013.223"},{"key":"e_1_2_10_6_1","unstructured":"The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use. Ethnic factors in the acceptability a foreign clinical data E5 (R1). c1998 [cited 1998 February 5] Available from:http:\/\/www.ich.org\/fileadmin\/Public_Web_Site\/ICH_Products\/Guidelines\/Efficacy\/E5_R1\/Step4\/E5_R1__Guideline.pdf."},{"key":"e_1_2_10_7_1","unstructured":"The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use. General principle on planning\/designing Multi\u2010Regional Clinical Trials. C2017 [cited 2017 November 16] Available from:http:\/\/www.ich.org\/fileadmin\/Public_Web_Site\/ICH_Products\/Guidelines\/Efficacy\/E17\/E17EWG_Step4_2017_1116.pdf."},{"key":"e_1_2_10_8_1","doi-asserted-by":"publisher","DOI":"10.2133\/dmpk.DMPK-11-RV-111"},{"key":"e_1_2_10_9_1","doi-asserted-by":"publisher","DOI":"10.1038\/sj.clpt.6100482"},{"key":"e_1_2_10_10_1","doi-asserted-by":"publisher","DOI":"10.1177\/2168479013517892"},{"key":"e_1_2_10_11_1","doi-asserted-by":"publisher","DOI":"10.1111\/cts.12485"},{"key":"e_1_2_10_12_1","unstructured":"Pharmaceuticals and Medical Devices Agency. Report on the 4th China\u2013Korea\u2013Japan Director\u2010General Meeting and Working Group on Pharmaceutical Affairs. c2011 [cited2011October 31] Available from:https:\/\/www.pmda.go.jp\/files\/000152707.pdf."},{"key":"e_1_2_10_13_1","doi-asserted-by":"publisher","DOI":"10.1111\/bcp.12884"},{"key":"e_1_2_10_14_1","unstructured":"Ministry of Health Labour and Welfare. Basic Principles on Global Clinical Trials (Reference Cases) released by Ministry of Health Labour and Welfare in Japan. c2012 [cited 2012 September 5] Available from:https:\/\/www.pmda.go.jp\/files\/000208185.pdf."},{"key":"e_1_2_10_15_1","doi-asserted-by":"publisher","DOI":"10.3310\/hta5330"},{"key":"e_1_2_10_16_1","doi-asserted-by":"publisher","DOI":"10.1192\/bjp.134.4.382"},{"key":"e_1_2_10_17_1","doi-asserted-by":"publisher","DOI":"10.1192\/bjp.133.5.429"},{"volume-title":"Conners' adult ADHD rating scales (CAARS)","year":"1999","author":"Conners CK","key":"e_1_2_10_18_1"},{"key":"e_1_2_10_19_1","doi-asserted-by":"publisher","DOI":"10.1007\/s11136-005-8325-z"},{"key":"e_1_2_10_20_1","doi-asserted-by":"publisher","DOI":"10.1111\/bcp.13807"}],"container-title":["British Journal of Clinical Pharmacology"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/api.wiley.com\/onlinelibrary\/tdm\/v1\/articles\/10.1111%2Fbcp.13893","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/pdf\/10.1111\/bcp.13893","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/full-xml\/10.1111\/bcp.13893","content-type":"application\/xml","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/bpspubs.onlinelibrary.wiley.com\/doi\/pdf\/10.1111\/bcp.13893","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2023,9,10]],"date-time":"2023-09-10T07:12:17Z","timestamp":1694329937000},"score":1,"resource":{"primary":{"URL":"https:\/\/bpspubs.onlinelibrary.wiley.com\/doi\/10.1111\/bcp.13893"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2019,3,28]]},"references-count":19,"journal-issue":{"issue":"6","published-print":{"date-parts":[[2019,6]]}},"alternative-id":["10.1111\/bcp.13893"],"URL":"https:\/\/doi.org\/10.1111\/bcp.13893","archive":["Portico"],"relation":{},"ISSN":["0306-5251","1365-2125"],"issn-type":[{"type":"print","value":"0306-5251"},{"type":"electronic","value":"1365-2125"}],"subject":[],"published":{"date-parts":[[2019,3,28]]}}}