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ICH E9 (R1) - 日本製薬工業協会

Concept Paper (2014 年10月承認) Title Addendum to Statistical Principles for Clinical Trials on Choosing Appropriate Estimands and Defining

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Text of ICH E9 (R1) - 日本製薬工業協会

ICH E9 (R1) 15 Jan 2016 ICH 2015 ( 33 ICH ) 1 Outline Estimand 2 1998 : E9 ( ) 2013 : EU 2014 5-10 E9 (R1) EWG , Concept Paper 2014 11 : EWG 1 estimand 2015 6 : EWG 2 2015 12 : EWG 3 3 2015 12 Jacksonville : 4 EU Robert Hemmings*, Frank Petavy EFPIA Christine Fletcher (Amgen), Frank Bretz (Novartis) MHLW / PMDA Yuki Ando, Ayako Hara, Hirofumi Minami JPMA Satoru Tsuchiya, Satoru Fukinbara FDA Estelle Russek-Cohen**, Tom Permutt PhRMA Devan V. Mehrotra (Merck), Vladamir Dragalin (J & J) Health Canada Catherine Njue DoH of Chinese Ta ipei Mey Wang DRA of Brazil Carolina Pingret *: Rapporteur, **: Regulatory Chair Concept Paper (2014 10 ) Title Addendum to Statistical Principles for Clinical Trials on Choosing Appropriate Estimands and Defining Sensitivity Analyses in Clinical Trials Note Estimand ( ) ? (sensitivity analysis) 5 E9 (R1) E9 : Estimand: - : E9 (R1) Estimand 6 Step1 technical document (= ) Technical appendix Clinical/Medical E9 ICH ( ) 2015 EWG ( ) EWG 7 Estimand (1/2) Target population, Endpoint, Measure of intervention effect estimand estimand Estimand 8 Estimand (2/2) E9 ITT 2 E9 (R1) EWG estimand estimand (pros/cons) 9 E9 P estimand : estimand : estimand 10 estimand ? estimand 20 11 Step1 technical document (= ) E9 Clinical/Medical Estimand Technical appendix /e-mail Step1 2016 6 or 10 : 12

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