Standards Metadata Management (System)

Transcription

1 Standards Metadata Management (System) Kevin Lee, MarkLogic COPYRIGHT 2015 MARKLOGIC CORPORATION. ALL RIGHTS RESERVED.

2 Agenda Regulatory Requirement on Clinical Trial Standards(i.e., CDISC and ectd) Standards driven clinical artefacts development process Standards Metadata Management Metadata Management System Final Thoughts SLIDE: 2

3 Standards? What do we think first about Standards? SLIDE: 3

4 Standards based electronic submission of clinical trial data SLIDE: 4

5 Current Status in ectd Standards Submission in CDER FDA Current Status in esubmission in CDER FDA SLIDE: 5

6 Current Status in CDISC Submission in CDER FDA SLIDE: 6 In 2010, 23% of SDTM in NDA In 2011, 39% of SDTM and 32% in ADaM in NDA In 2013, 55% of SDTM in NDA

7 Section 745A(a) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) Enhanced by Food and Drug Administration Safety and Innovation Act (FDASIA) on July 9, Requires that submissions be submitted in electronic format. SLIDE: 7

8 New FDA Guidance on CDISC esubmission Binding rather than recommendation Guidance for Industry: Providing Regulatory Submissions in Electronic Format Submissions Under Section 745A (a) of the Federal Food Drug, and Cosmetic Act Guidance for Industry: Providing Regulatory Submissions in Electronic Format Standardized Study Data SLIDE: 8

9 New FDA Guidance on CDISC esubmission - continued Can FDA Refuse to File / Receive if submission data does not follow estudy Guidance? YES SLIDE: 9

10 What else for Standards? Anything else beside submission? What else can we do with standards? SLIDE: 10

11 How does your organization want to use CDISC Standards in the future? Regulatory compliance Reuse of Standards Operation Efficiency Faster time to submission Data interoperabiltiy with other Standards (e.g., HL7) Data compliance of external vendor Standards-based or driven clinical trial artefacts development SLIDE: 11

12 Standards based submission Standards driven process SLIDE: 12

13 Henry Ford Assembly Line The Model T was Ford's first automobile mass produced on moving assembly lines with completely interchangeable STANDARDized parts. (Dec 1 st, 1913) SLIDE: 13

14 Model T production and price over year 2,500,000 2,000,000 1,500,000 1,000, ,000 0 $1,000 $900 $800 $700 $600 $500 $400 $300 $200 $100 $0 Production Price for SLIDE: : $900 and 20,000 vs 1925: $260 and 2,000,000

15 Can we accomplish similar production increases and cost reduction in clinical artefacts development like Henry Ford did? SLIDE: 15

16 Henry Ford Assembly line vs Clinical artefacts development process Henry Ford Car production Clinical artefacts development Model T SDTM datasets Interchangeable Standardized parts SDTM & CDASH(EDC), CT standards Automated Assembly line Automated ETL system SLIDE: 16

17 Standards driven clinical artefacts development Standards SDTM ADaM ETL system Clinical Artefacts SDTM datasets ADaM datasets SLIDE: 17

18 Questions What are required for standards-driven clinical artefacts development? SLIDE: 18

19 Requirements for standards-driven automated clinical artefacts development Standards Metadata Management System ETL Systems SLIDE: 19

20 Possibility with Standards Metadata Management(MdM) and ETL system Standards Metadata Management System ETL System 1 Clinical Artefacts 1 (Protocol) ETL System 2 Clinical Artefacts 2 (CDASH/EDC) ETL System 3 Clinical Artefacts 3 (SDTM) ETL System 4 Clinical Artefacts 4 (ADaM) ETL System 5 Clinical Artefacts 5 (TFL) SLIDE: 20

21 Standards Metadata Management Definition Managing Standards Metadata (data about data) Definition of metadata Data about data/document Title: Star Wars: Episode VII - The Force Awakens Release Date: Dec 18 th, 2015 Director: J.J. Abrams Cast: Harrison Ford, Mark Hamill, Carrie Fisher Genres: Action, Adventure, Fantasy, Sci-Fi SLIDE: 21 Metadata

22 Standards Metadata Management - continued Metadata of clinical trial data Dataset: DM Description: Demographics Class: Special Purpose Domains Structure: One record per subject Keys: STUDYID, USUBJID Versions: SDTMIG 3.2 SLIDE: 22

23 Standards Metadata Management - continued Types of Standards metadata Protocol (e.g.,prm) CDASH SEND SDTM ADaM Define.xml Dataset.xml Any company specific Standards SLIDE: 23

24 Architetcure of Standards Metadata Management System Standards 1 (Protocol) Standards 2 (CDASH/EDC) Standards Metadata Management System ETL System 1 Clinical Artefacts 1 (Protocol) ETL System 2 Clinical Artefacts 2 (CDASH/EDC) Standards 3 (SDTM) ETL System 3 Clinical Artefacts 3 (SDTM) Standards 4 (ADaM) ETL System 4 Clinical Artefacts 4 (ADaM) Standards 5 (TFL) ETL System 5 Clinical Artefacts 5 (TFL) SLIDE: 24

25 Examples of Standards Metadata Management Creating new standards (e.g., variables and domains) Storage of Standards Modifying the attributes (e.g., label, type) of current standards Adding the new attributes to current standards Archiving the standards Assigning versions (e.g., major or minor) to standards after changes Maintaining multiple versions of standards (e.g., SDTMIG 3.1.2, 3.1.3) And many more Standards metadata driven process SLIDE: 25

26 What does it mean by Standards metadata driven process? Standards metadata first or Standards data first? Create metadata first or data first? SLIDE: 26

27 Why Standards metadata first? Easier to regulatory compliance Provide requirements / directions to programmers or developers Don t need to create metadata(define.xml) again Possible standards metadata driven process -> automated process using ETL and MdM Standards driven clinical trial artefact development process How can we do it? By Metadata System SLIDE: 27

28 Evolution of metadata system Database Metadata Management System Spreadsheet or document SLIDE: 28

29 Metadata Management (MdM) System Definition Database created to store metadata Function Storages of Standards metadata in global library Manage Standards metadata Govern Standards metadata Create study level metadata from global library Receive metadata from other systems (e.g., CDISC SHARE) Feed metadata to other system(e.g., EDC and ETL system) SLIDE: 29

30 Standards Metadata in MdM system Structural metadata of source data Dataset Variable Name Variable Label Type CT DEMO USID Unique Subject Identifier Char Structural metadata of target data Dataset Variable Name Variable Label Type CT Role DM USUBJID Unique Subject Identifier Char Identifier DM Age Age Num Identifier SLIDE: 30

31 Standards Metadata in MdM system - continued System readable transformation metadata from source to target data Target dataset Target variable Machine readable derivation Source dataset Source variable DM USUBJID = DEMO USID DM AGE %AGE(RFSTDTC BRTHDTC) data dm;; set demo;; usubjid = usid;; age = %age(rfstdtc brthdtc);; run;; SLIDE: 31

32 Data flow of Standards Metadata in MdM system to ETL and clinical artefacts Standards Metadata Management System Structural metadata for source Machine-readable Transformation metadata from source to target Structural metadata for target Source Data ETL System Target Data SLIDE: 32

33 Semantics-driven Standards Metadata development DEMO DM hasvariable hasvariable hasvariable USID USUBJID AGE require = Derivation Derivation %age(rdfdtc-brthdtc) Rather than row and column structured metadata, developing with semantic based RDF/graph-based smetadata -> PhUSE SLIDE: 33

34 Study level metadata definition development in MdM MdM Global Library Protocol CDASH Study level (e.g., 001) Protocol CDASH SDTM ADaM TFL SDTM ADaM TFL SLIDE: 34

35 Semantics-driven Study level metadata definition development in MdM Global Library MdM Study level (e.g., 001) Protocol CDASH Protocol CDASH SDTM ADaM TFL SDTM ADaM TFL SLIDE: 35

36 Semantics-driven Study level metadata definition development in MdM : Oncology SLIDE: 36 Protocol Cheson 2007 CDASH/ EDC Tumor Measurement Bone Marrow Assessment Spleen and Liver Enlargement Response SDTM TR TU LB FA PE RS ADaM ADTTEPFS TFL Progression Free Survival Time to Event TFL Integration from Protocol to Analysis through semantic-linked Standards End to End Standardization System using semantics-driven Standards metadata could automate oncology-specific artifacts developments

37 Why is Study Level metadata definition in MdM important? MdM Study 001 Protocol CDASH SDTM It can dictate study level artefacts development. ETL Study 001 Protocol EDC database ecrf SDTM datasets ADaM ADaM datasets TFL TFL SLIDE: 37

38 Final Thought Management Standards Standards Metadata Regulatory Clinical Data Submission Standards Metadatadriven Clinical Artefacts Development SLIDE: 38

39 Contacts and Questions Kevin Lee LinkedIn: Slides: Blogs: HiKevinLee.tumblr.com SLIDE: 39

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