NUVISAN PHARMA SERVICES

D l t f D t St d d d D tDevelopment of Data Standards and Data Integration tools

Rafael RomeroDirector Global Clinical Data Management & eTrials

Epharma DayBarcelona 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)• Data Integration Tools (ETL)

• Clinical Data Standards Future

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CLINICAL DATA STANDARDS LANDSCAPE

Why a four year old child couldWhy a four year old child could understand this.

Run out and get me a four year old childRun out and get me a four year old child, I can't make head or tail out of it.

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Groucho Marx

CLINICAL DATA STANDARD LEADING ORGANIZATIONS

• Global, open, multidisciplinary, consensus-Clinical Data , p , p y,based, non-profit

• Founded in 1997• >200 members• Mission: Established worldwide industry

standards to s pport the electronic acq isition

Clinical Data Standards

Interchange C ti standards to support the electronic acquisition,

exchange, submission and archiving of clinical trials data and metadata

Consortium (CDISC)

• Not for profit, ANSI-accredited Standard developing organizationF d d i 1987

Health Level • Founded in 1987• >2300 members• Mission: provide a comprehensive framework

and related standards for exchange, integration, sharing, and retrieval of electronic

Seven international

(HL7)

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eg a o , s a g, a d e e a o e ect o chealth information(HL7)

STANDARDS DEVELOPMENT EVOLUTION• FDA give a clear message to

receive data in CDISC SDTM, ADaM and define xml

• Internal company data standards• Data standards inconsistent and

differ wildly from company to

ADaM and define.xml• FDA main goal is increase

patient’s safety

company• Different needs: data managers,

statisticians, clinicians, etc

• 1987 HL7 born but patient data not easily translated into the clinical research arena

• Clinical data were “special”R ti d t d t f

• 1998 CDISC born for developing data standards for clinical research

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• Recreating processes and metadata from scratch

• Inconsistent methods for colleting data elements (ie. Gender)

FDA ENDORSES CDISC STANDARDS AS SPECIFICATIONS IN FINAL GUIDANCE

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CDISC MODELSModel/Standard Title

Clinical Data Acquisition Standards Harmonization (CDASH)

Data model for a core set of global data collection fields(element name, definition, metadata)

Study Data Tabulation Model (SDTM) Data model supporting the submission of data to the FDAincluding standard domains variables and rulesincluding standard domains, variables, and rules

Analysis Dataset Model (ADaM) Data model closely related to SDTM to support the statisticalreviewer by providing data and metadata that is analysis ready

Define xml XML Specification to contain the metadata associated with aDefine.xml XML Specification to contain the metadata associated with aclinical study for submission

Standard for the Exchange of Non Clinical Data model extending SDTM to support the submission ofData (SEND) animal toxicity studies

Protocol Representation Model (PRM) Metadata model focused on the characteristics of a study andthe definition and association of activities within the protocols,including "arms" and "epochs"

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Terminology Standard list of terms across all the CDISC data models

GLOBAL CDISC INTEGRATIONGLOBAL CDISC INTEGRATION

8Data source: Business & Decision Life Sciences

CDISC BENEFITS

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Data source: “CDISC: Adoption Trends, Benefits and Addressing Barriers” n=508 published Oct-2011

THE VALUE OF CDISC

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Data Source: “The Value of CDISC: Results of a Brief Survey “ published Oct-2011

CDISC ADOPTION BARRIERS

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Data source: “CDISC: Adoption Trends, Benefits andAddressing Barriers” published Oct-2011

CDISC ADOPTION FIGURES

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Data source: “CDISC: Adoption Trends, Benefits andAddressing Barriers” published Oct-2011

WHAT IS AN ETL TOOL?

Extract Transform Load

• Advantages• Documentation and Change Control• Centrally managed metadata (single source of truth)• Transformations Impact analysis

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WHY IS ETL KEY FOR FUTURE?

Data Study Integrationg

Cross-Study Data Integration

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FUTURE: SHORT TERM

• Increase adoption of CDISC StandardsSDTM• SDTM

• CDASH

• New CDISC Standards (Therapeutic area specific)

• Clinical data integration• eCRFs• ePRO• IVRS• CTMS• Central Lab

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• Increase use of Clinical Data Warehousing

FUTURE: MEDIUM TERM

• EHR integration with Clinical D tData• 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: “eSourceFDA define eSource as: eSource documents and eSource data are used to describe source documents and source data for which the original

d d tifi d i i iti ll

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record and certified copies are initially captured electronically”

CDISC

HL7

TWO WORLDS CONVERGEBRIDG

CDISC

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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 medicinehealth care, life sciences, clinical research and translational medicine• Linking Open Drug Data (LODD) initiative

• Open PHACTS project• 14 European Academic and SME partnersp p• 8 EFPIA members

Subject ObjectProperty

<Patient HB2122> <shows_sign> <Disease Pneumococcal_Meningitis>

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THANKS !!!!

RAFAEL ROMERODIRECTOR GLOBAL CLINICAL DATA MANAGEMENT & ETRIALSDIRECTOR GLOBAL CLINICAL DATA MANAGEMENT & ETRIALS

RAFAEL.ROMERO@NUVISAN.COMPHONE : +34 913 726 064MOBILE: +34 670 836 330