{"title":"回顾“临床试验中多重性问题的考虑要点”和需要讨论的问题","authors":"S. Fujikoshi","doi":"10.5691/JJB.27.S64","DOIUrl":null,"url":null,"abstract":"“Points to Consider on Multiplicity Issues in Clinical Trials” published by CPMP of EMEA in September 2003 is reviewed and issues to be discussed are identified. First, the examples identified in the PtC as unnecessary cases of “adjusting the type I error level” are grouped into 3 patterns, and the situation and the characteristics of each pattern are explained. After reviewing each pattern, important points for conducting the confirmatory trial according to PtC are summarized. Issues to be discussed about the content and the concrete measures are also addressed.","PeriodicalId":365545,"journal":{"name":"Japanese journal of biometrics","volume":"10 1","pages":"0"},"PeriodicalIF":0.0000,"publicationDate":"2006-09-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Review of \\\"Points to Consider on Multiplicity Issues in Clinical Trials\\\" and Issues to be Discussed\",\"authors\":\"S. Fujikoshi\",\"doi\":\"10.5691/JJB.27.S64\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"“Points to Consider on Multiplicity Issues in Clinical Trials” published by CPMP of EMEA in September 2003 is reviewed and issues to be discussed are identified. First, the examples identified in the PtC as unnecessary cases of “adjusting the type I error level” are grouped into 3 patterns, and the situation and the characteristics of each pattern are explained. After reviewing each pattern, important points for conducting the confirmatory trial according to PtC are summarized. Issues to be discussed about the content and the concrete measures are also addressed.\",\"PeriodicalId\":365545,\"journal\":{\"name\":\"Japanese journal of biometrics\",\"volume\":\"10 1\",\"pages\":\"0\"},\"PeriodicalIF\":0.0000,\"publicationDate\":\"2006-09-30\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Japanese journal of biometrics\",\"FirstCategoryId\":\"1085\",\"ListUrlMain\":\"https://doi.org/10.5691/JJB.27.S64\",\"RegionNum\":0,\"RegionCategory\":null,\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"\",\"JCRName\":\"\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Japanese journal of biometrics","FirstCategoryId":"1085","ListUrlMain":"https://doi.org/10.5691/JJB.27.S64","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"","JCRName":"","Score":null,"Total":0}
Review of "Points to Consider on Multiplicity Issues in Clinical Trials" and Issues to be Discussed
“Points to Consider on Multiplicity Issues in Clinical Trials” published by CPMP of EMEA in September 2003 is reviewed and issues to be discussed are identified. First, the examples identified in the PtC as unnecessary cases of “adjusting the type I error level” are grouped into 3 patterns, and the situation and the characteristics of each pattern are explained. After reviewing each pattern, important points for conducting the confirmatory trial according to PtC are summarized. Issues to be discussed about the content and the concrete measures are also addressed.
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