Development_data_standards_data_integration_tools

NUVISAN PHARMA SERVICESDevelopment of Data Standards and D tD l t f D t St d d d Data Integration tools Rafael Romero Director Global Clinical Data Management & eTrials Epharma Day Barcelona 27-Oct-2011

CONTENT• Clinical Data Standards leading organizations• Clinical Data Standards Evolution• CDISC • M d l Models • Value • Ad ti Adoption • Barriers• Data Integration Tools (ETL)• Clinical Data Standards Future 2 2

CLINICAL DATA STANDARDS LANDSCAPE Why a four year old child could understand this. Run out and get me a four year old child, child I cant make head or tail out of it. Groucho Marx 3

CLINICAL DATA STANDARD LEADING ORGANIZATIONS Clinical Data • Global, open, multidisciplinary, consensus- , p , based, non-profit p y, Standards • Founded in 1997 • >200 members Interchange • Mission: Established worldwide industry standards to s pport the electronic acquisition, support acq isition Consortium C ti exchange, submission and archiving of clinical (CDISC) trials data and metadata • Not for profit, ANSI-accredited Standard Health Level •F developing organization Founded i 1987 d d in Seven • >2300 members • Mission: provide a comprehensive framework international and related standards for exchange, (HL7) integration, sharing, and retrieval o electronic eg a o , s a g, a d e e a of e ect o c health information 4

STANDARDS DEVELOPMENT EVOLUTION • FDA give a clear message to receive data in CDISC SDTM, ADaM and define.xml define xml • FDA main goal is increase• Internal company data standards patient’s safety• Data standards inconsistent and differ wildly from company to company• Different needs: data managers, statisticians, clinicians, etc • 1987 HL7 born but patient data not easily translated into the clinical research arena • 1998 CDISC born for developing data standards for clinical research • Clinical data were “special” • Recreating processes and metadata f R ti d t d t from scratch • Inconsistent methods for colleting data elements (ie. Gender) 5

FDA ENDORSES CDISC STANDARDS AS SPECIFICATIONS INFINAL GUIDANCE 6

CDISC MODELSModel/Standard TitleClinical Data Acquisition Standards Data model for a core set of global data collection fieldsHarmonization (CDASH) (element name, definition, metadata)Study Data Tabulation Model (SDTM) Data model supporting the submission of data to the FDA including standard domains, variables, and rules domains variablesAnalysis Dataset Model (ADaM) Data model closely related to SDTM to support the statistical reviewer by providing data and metadata that is analysis readyDefine.xmlDefine xml XML Specification to contain the metadata associated with a clinical study for submissionStandard for the Exchange of Non Clinical Data model extending SDTM to support the submission ofData (SEND) animal toxicity studiesProtocol Representation Model (PRM) Metadata model focused on the characteristics of a study and the definition and association of activities within the protocols, including "arms" and "epochs"Terminology Standard list of terms across all the CDISC data models 7

GLOBAL CDISC INTEGRATION 8Data source: Business & Decision Life Sciences

CDISC BENEFITSData source: “CDISC: Adoption Trends, Benefits and AddressingBarriers” n=508 published Oct-2011 9

THE VALUE OF CDISCData Source: “The Value of CDISC: Results of a Brief Survey “published Oct-2011 10

CDISC ADOPTION BARRIERSData source: “CDISC: Adoption Trends, Benefits and Addressing Barriers” published Oct-2011 11

CDISC ADOPTION FIGURESData source: “CDISC: Adoption Trends, Benefits and Addressing Barriers” published Oct-2011 12

WHAT IS AN ETL TOOL? Extract Transform Load • Advantages • Documentation and Change Control • Centrally managed metadata (single source of truth) • Transformations Impact analysis 13

WHY IS ETL KEY FOR FUTURE? Data Study Integration g Cross-Study Data Integration 14

FUTURE: SHORT TERM • Increase adoption of CDISC Standards • SDTM • CDASH • New CDISC Standards (Therapeutic area specific) • Clinical data integration • eCRFs • ePRO • IVRS • CTMS • Central Lab • Increase use of Clinical Data Warehousing 15

FUTURE: MEDIUM TERM• EHR integration with Clinical Data D t • FDA has made a draft guidance in Dec/2010 about eSource data and documents • EMA has made a paper in Aug/2010 about their expections about eSource• FDA define eSource as: “eSource eSource documents and eSource data are used to describe source documents and source data for which the original record and certified copies are i iti ll d d tifi d i initially captured electronically” 16

HL7 CDISCTWO WORLDS CONVERGE BRIDG 17

FUTURE: LONG TERM• Semantic web • Semantic web Health Care and Life Sciences (HCLS) Interest Group a W3C initiative • Develop, advocate for, and support the use of Semantic Web technologies across health care life sciences clinical research and translational medicine care, sciences, • Linking Open Drug Data (LODD) initiative • Open PHACTS project • 14 European Academic and SME p p partners • 8 EFPIA members Subject Property Object <Patient HB2122> <shows_sign> <Disease Pneumococcal_Meningitis> 18

THANKS !!!! RAFAEL ROMERODIRECTOR GLOBAL CLINICAL DATA MANAGEMENT & ETRIALS RAFAEL.ROMERO@NUVISAN.COM PHONE : +34 913 726 064 MOBILE: +34 670 836 330

Development_data_standards_data_integration_tools

by Rafael Romero

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