TOC Current status Challenges Solutions 2

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1 e-submission Challenges for CFDA NDA Filing --Current status, challenge and solution of data submission in China -- 中国数据递交的现状挑战与解决之道 Victor Wu CDISC Authorized SDTM Instructor Vice Chair, China CDISC Coordinating Committee Chief Consultant Vice President, Data Science Department, Beijing Data Science Express Consulting Co., ltd 吴崇胜 CDISC 认证 SDTM 讲师 CDISC 中国协调委员会副主席首席咨询师数据科学中心副总裁北京迪时咨询有限公司 1

2 TOC Current status Challenges Solutions 2

3 Current Status Ø Why standards? Ø Why CDISC? Ø Where we are? 3

4 World without Standardization 4

5 Data without Standardization Demographics Study#1 demog.xpt SUBJID SEX 0001 M 0002 F 0003 F 0004 M 0005 F Study#3 axd222.xpt USUBID SEX Study#3 dmgph.xpt PTID GENDER

6 More Data, More Headaches? Ø Where is data needed? Ø What dose it mean?! Ø The data was coded in different way, pool them?! 6

7 What s data standards about? A standard way to organize and format study data dm.xml STUDYID DOMAIN USUBJID SUBJID AGE AGEU SEX RACE CDE01 DM CDE YEARS F WHITE CDE01 DM CDE YEARS M WHITE CDE01 DM CDE YEARS M WHITE CDE01 DM CDE YEARS F WHITE CDE01 DM CDE YEARS M WHITE CDE01 DM CDE YEARS F ASIAN CDE01 DM CDE YEARS M WHITE CDE01 DM CDE YEARS M WHITE CDE01 DM CDE YEARS M BLACK OR AFRICAN AMERICAN 7

8 Standardized vs Non-standardized Ø Dataset level Name Description Structure Allowed Variables Ø Variable level Name Label Type Format Ø Value level Controlled Terminology 8

9 Why CDISC? To build China data submission standards, or To use the prepared CDISC standards? And the final agreement is to use CDISC standards, to keep consistent with global. 9

10 Where we are? 2013 June: Steering Committee, China CDE Specific Work on Clinical Data Standardization 指导组 August: 5 Working Groups, China CDE Specific Work on Clinical Data Standardization 工作组 2014 年 CDASH, SDTM, ADaM, CT, ODM document Translation Quarterly Seminar on CDISC 2016 目标 : 完成中国临床试验数据递交要求草案包括技术依从性指南 10

11 中国 CDE 临床试验数据标准化专项工作指导组 China CDE Specific Work on Clinical Data Standardization -- Steering Committee Responsibilities 指导组的职责促进指导和规划国内临床试验数据标准的统一工作 Members 指导组的成员 CDE staff, CDISC standards Experts, data management professionals, statistician, clinical/medical experts CDE 人员 CDISC 标准专家数据管理专家统计专家临床专家 Working Scope 工作内容部署工作讨论问题规划进度讨论共识度审阅工作组提交的专题标准, 及采用措施 ( 即发布或不发布 ), 药审中心在指导组审核发布的基础上, 根据情况实行进一步监管要求 : 推荐使用还是强制使用 11

12 CDE 临床试验数据标准化专项工作专题工作组 China CDE Specific Work on Clinical Data Standardization -- Working Group CDASH/SDTM/ADaM/CT/TCM/ODM & Define.xml Responsibilities 主要任务 Plan 制定工作计划和时间表 Translation and localization, come to industry consensus through discussion 汉化和本土化, 开展业界讨论达成共识 Feasibility assessment 可行性研究 Training and promotion 培训和应用推广 Member 工作组成员 Lead 组长 Member 成员 : Experts, regulatory reviewers, and volunteers 由专家审评员和志愿者组成 Welcome to join the working group! 欢迎所有有志于临床试验数据标准化的同行参加! 12

13 TOC Current status Challenges Solutions 13

14 Challenges - Technically language issue such as CT; date format; people; Traditional Chinese Medicine 14

15 Challenges - Capability Capability of Implementation in local companies: lack of knowledge and Lack of experience 15

16 Challenges - Policy Policy from regulatory agency Clear voice? 16

17 TOC Current status Challenges Solutions 17

18 Solutions - Policy Regulatory need to be more aggressive: Japan is a good example Once statistical review become routine practice, there will be immediate needs 18

19 Solutions - Technically Working Group is working on data submission proposal and China implementation guide language issue such as CT: Translated Core CT date format: YYYY-MM-DD or MMDDDYYYY People: RACEOR? Traditional Chinese Medicine: New/Custom Domain C3C will organize trainings on it 19

20 Solutions - Capability Company level: to realize the importance of data standards, which will improve quality and efficiency, not just meet regulatory needs Staff: Hire the experience person and provide training CDISC Public training Turn to external experts: to leverage knowledge and experience, to simplify implementation through process, templates and tools 20

21 Ask 21

22 Thank You 谢谢! Strength through collaboration

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