SHARE S&V D tSHARE S&V Document and theand the

PilotPathway into the Future for Standards Development andStandards Development and Delivery

April 2010

Bron W. Kisler, CDISC Senior Directorbki l @ di

11

bkisler@cdisc.org

CDISC Mission

T d l d t l b l l tf

CDISC Mission

To develop and support global, platform-independent data standards that enable i f i i biliinformation system interoperability to

improve medical research and related areas of healthcare

Strength through collaboration.

22

CDISC SnapshotCDISC Snapshot

�• Global standards organization initiated in 1997 as a gvolunteer group; incorporated as non-profit in 2000

�• Established worldwide standards to support the electronic acquisition exchange analysis andelectronic acquisition, exchange, analysis and submission of clinical research data

�• 200+ corporate sponsors and member organizations p p g(Global Pharmas, Service Organizations, Technology Vendors, Academic Institutions)

�• Established Coordinating Committees and annual�• Established Coordinating Committees and annual events in North America, Europe and Japan

�• Expanding activities in China, India and BrazilExpanding activities in China, India and Brazil�• Liaison A organization to ISO TC-215; member of

Joint Initiative Council

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CDISC Standards and Data Flow

44

Opening Remarks by CDISC Chair, Dr Edward Helton (SHARE presentation Oct 2009)Dr. Edward Helton (SHARE presentation Oct. 2009)

�• The Clinical Data Interchange Standards Consortium (CDISC)The Clinical Data Interchange Standards Consortium (CDISC) is a global standards development organization.

�• CDISC has developed a suite of standards to support the li i l h f l iclinical research process from protocol representation

through analysis and reporting, with a focus to date on safety data domains.y

�• These encompass protocol-driven research, including regulated research.CDISC d it b t dditi l t t t d d�• CDISC and its members want additional content standards (to support efficacy, eligibility, clinical content) to be developed more rapidly.

�• CDISC standards are open and freely available (www.cdisc.org)

55

What is CDISC SHARE?What is CDISC SHARE?

A globally accessible electronic library built on a common information modelbuilt on a common information model, which (through advanced technology) enables precise and standardised dataenables precise and standardised data element definitions that can be used in

studies and applications to improve biomedical research and it�’s link with

healthcare

66

Why SHARE?Why SHARE?�• Integrate current CDISC standards and extend them

i h ffi l d d i / d hwith efficacy-related domains / content and other needed standards in an electronic, accessible format

�• Help to ensure terminology for research standards is�• Help to ensure terminology for research standards is consistent as much as possible with that needed for other purposes (e.g. EHRs, quality reporting, public p p ( g , q y p g, phealth, safety monitoring)

�• Strengthen the link between clinical care and research h h h l i f h l hsuch that research results can inform healthcare more

quickly�• Develop a �‘reference�’ or target set of standards�• Develop a reference or target set of standards

without duplication of existing standards (e.g. target for mapping legacy/retrospective data)

77

pp g g y p )

SHARE Project: Inception Phase(M h D b 2009)(March �– December 2009)

�• Goal: Evaluate feasibility; determine future pathGoal: Evaluate feasibility; determine future path

�• Scope & Vision Document�– Business RequirementsBusiness Requirements

�– Governance Process, Workflow and Requirements

�– Detailed Stakeholder Assessment

�– Business Models

�• Pilot �– Technology and tools (Mayo/NCI LexGrid)

�– Terminologies and vocabularies for harmonization (n=7)

�– New/comparable content (Oncology) from 5 sources (Mayo, MD Anderson, GSK, Genzyme, Lilly)

�– Evaluation and Metrics (Pilot Report January 2010)

88

( p y )

CDISC SHARE: ContributeCDISC SHARE: Contribute

Within an organization the extraction andWithin an organization the extraction and formatting of existing definitions for loading

into the CDISC SHARE environment.

Pilot used an excel spreadsheet

Also used a Lilly ODM file exported fromAlso used a Lilly ODM file exported from their internal system, which was then converted to Excel spreadsheet form

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p

CDISC SHARE: LinkCDISC SHARE: Link

Attempt to align an organization�’sAttempt to align an organization s internal world with the outside world

BRIDG & CDISC NCIt & M tNCIt & MetaSNOMED CT

UCUM, ICD 10

Cloud of Knowledge1010

Cloud of Knowledge

CDISC SHARE: Mergeg

Org A

BRIDG & CDISC NCIt & MetaNCIt & MetaSNOMED CT C C 0Org B UCUM, ICD 10 Org B

Org COrg C

By using the links the �“machine�” can

1111

By using the links the machine can group similar source definitions

CDISC SHARE: Harmonize

...

...

Group like data elements and definitions b itt d b diff t i ti dsubmitted by different organizations and

worked on by the community to align and agree to the consensus version.

1212

to the consensus version.

CDISC SHARE: Harmonize

Value Set = A,B,C, ,

Value Set = X,Y

Value Set = A,X,Y

Value Set = N M O P Q RValue Set = N,M,O,P,Q,R

Value Set = ???Value Set = ???

Align value sets. Source these from standard gterminologies if possible.

1313

Harmonize �– �“Clumps�”p

...

...Relationship between the element definitionselement definitions

Form �“logical�” groupings (e.g. BP = SYSBP, DIABP B d L i B d P i i )

1414

DIABP, Body Location, Body Position etc.)

New DefinitionNew Definition

L N�• Long Name�• Short Name�• Definition�• Data Type�• Data Type�• Value Set�• Concepts Linked To�• Sources of Definition

1515

Pilot AimsPilot Aims�• Primary

�– Determine whether definitions taken from multiple sources can be merged into a single reference version agreed to by

ll ti d thi b d ithi ti f th tall parties, and can this be done within a timeframe that makes business sense

Determine whether high quality definitions can be created�– Determine whether high-quality definitions can be created, and can existing ontologies help in ensuring such while avoiding duplicate definitions from being createdg p g

�• SecondaryProvide any relevant lessons to future development work�– Provide any relevant lessons to future development work

�– Refine user, business and governance requirements

1616

CDISC: Focus on Standard Content

CDISC Partners Software

CDISC: Focus on Standard Content

CDISC Partners( Technology )

Software

Hosting

CDISC

Inception

ElaborationCDISC& Collaborators( Content )

ConstructionTransition Production

1717

( Content )

CDISC: Focus on Standard ContentNCI �– tool development

CDISC: Focus on Standard Contentp

Technologygy�• Servers, Repository, Software , etc. = NCI�• Hosting = Central and/or Federated

CDISC / Content = CDISC and CollaboratorsContent Governance = CDISC and Collaborators

CDISC / Stakeholder

RequirementsBusiness Model and Funding�• CDISC - Core Standards�• External - Therapeutic Area Standards

CDISC SHARE �– content

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C ISC SHAR content

NCI Partnership�• NCI has produced and hosted CDISC terminology through

it E t i V b l S i (EVS) i l 2003

NCI Partnership

its Enterprise Vocabulary Services (EVS) since early 2003�• NCI also produces and hosts terminologies for FDA, NIH,

and a broad array of research and healthcare organizations y gnationally and internationally through EVS

�• NCI is migrating to new tools for semantic management including a next generation metadata repository (MDR)including a next generation metadata repository (MDR)

�• NCI has offered to include all CDISC SHARE requirements in its repository development process

�• NCI has requested direct CDISC participation in the development teamNCI i h t t t l f CDISC SHARE th t ill b�• NCI wishes to support tools for CDISC SHARE that will be customizable, global, and cover all therapeutic areas

1919

Margaret Haber, NCI EVS

NCI Partnership (2)NCI Partnership (2)�• NCI�’s MDR development will be based requirements from a

id i t f t i l d h d b dwide variety of groups to include research and broader healthcare standards; SDOs - HL7, CDISC and other; regulatory entities; pharmaceutical; providers and vendorsregulatory entities; pharmaceutical; providers and vendors

�• The new ISO 11179 standard MDR will be based on a federated distributed architecture; meaning it will befederated, distributed architecture; meaning it will be decentralized, allowing for multiple peer repositories

�• A platform independent model, to be openly shareableA platform independent model, to be openly shareable

�• Allows for modular development of many and varied customized applications and services for different users, but customized applications and services for different users, but with a common foundation and generic API

�• Open, Platform & Vendor Neutral, Distributable, Shareable

2020

p , f , ,Margaret Haber, NCI EVS

Why Partner with NCI?Why Partner with NCI?�• Proven terminology partnership with rapid turn-around

service and support for accelerating standards timelines

�• Reliable and globally accessible Best-of-Breed infrastructure for standards publication (DE�’s, Terminology, DAMs)

�• Ability to �“harmonize�” real-time with key partners without tl t d d icostly standards mapping

�• NCI plans align well with CDISC�’s mission as well as near and long term strategy (e g new disease areas)long-term strategy (e.g. new disease areas)

�• Offer to roll-in requirements (CDISC, HL7 CIC, others) and to provide extensive resources and expertise is unprecedentedprovide extensive resources and expertise is unprecedented

�• Open, Platform & Vendor Neutral, Distributable, Shareable where all CDISC standards can be aligned and published

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where all CDISC standards can be aligned and published

NCI-EVS NCIt content stakeholdersNCI

ACC1%

BioCARTA0%

caDSR1%

CDC1%

CRCHNCI-GLOSS RAND

SEER1% Swiss-Prot

3%UCUM

0%

Terminology SubsetsNCIFDA

CTCAECTRM_ID

CDISC 0%

CDISC6%

CRCH1%

NCI GLOSS3%

RAND1%

3%CDISC

NCI-GLOSS

Swiss-ProtCDC

CTCAE9%

DCP

CDCDCPDTP

CRCHACC

CTRM_ID6%

DCP1%

DICOM1%

DTP

ACCcaDSRDICOM

HL7ICH

1%

FDA

NCI Only42%

ICHICSRISOJAX

KEGG ID FDA19%

HL7

_MTHRANDSEER

BioCARTA

2222

HL71%ICH

1%ICSR1%

ISO1%

JAX1%

KEGG_ID1%

MTH1%

UCUM

NCI EVS T i l S iNCI-EVS Terminology Services

�• Subject Matter Expertise

�• Definition writing and analysis

�• Terminology tagging and sub-setting

�• Terminology coding that ensures cross-�• Terminology coding that ensures cross-harmonization with key partner organizations

�• Terminolog req ests and maintenance�• Terminology requests and maintenance

�• Links to other controlled terminologies as needed(e.g. FDA, MedDRA, ISO, UCUM etc.)

�• Extending into new disease areas

2323

Erin Muhlbradte , NCI EVS

Existing CDISC data standards currently coded in NCI-EVS NCIt.

Numbers StatusCDISC Controlled Terminology

SDTM 3360 PublishedCDASH 82 PublishedADaM 26 PublishedSEND 1928 Pilot

CDISC (SDTM CDASH) M t d tCDISC (SDTM+CDASH) Metadata Domains 45 PublishedObservation Classes 200 Harmonization

V i bl 654 H i tiVariables 654 HarmonizationCDISC Disease Standards

Cardiovascular 25 Mapping in EVS

T b l i 130+ M i i EVSTuberculosis 130+ Mapping in EVS Polycystic Kidney Disease

200+Mapping in

EVS

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Published in .xls and .txt for download (.xml coming soon!)

Current NCI Semantic InfrastructureCurrent NCI Semantic Infrastructure

Information Models

NCI�’s

Information Models

Semantic InfrastructureData Elements

Vocabulary

//

Vocabulary

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https://cabig-kc.nci.nih.gov/Vocab/KC/index.php/SI_Conop_Existing_caBIG_Semantics_Implementation

Future Semantic Infrastructure

ISO

BRIDG

WikiGforgeMetadata

Eclipse Modeling Framework

WikiGforgeRepository

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Governance

https://cabig-kc.nci.nih.gov/Vocab/KC/index.php/SI_Conop_The_Semantic_Infrastructure_View

Change Control

CDISC SHARE Project Planj

Q1 10 Q1 11 Q2 11Q2 10 Q3 10 Q4 10

TEAM 1 & 2 - REQUIREMENTS

TEAM 1 - SAFETY CONTENT

NCI Release

TEAM 1 - EFFICACY CONTENT

TEAM 2 - GOVERNANCE & METADATAPackage 1 Package 2

NCI BASED TECHNOLOGY DEVELOPMENT

EDUCATION & USER SUPPORT

1.0

USE OF THE NCI�’S �“REPOSITORY�”

GO C &MODEL

EDUCATION & USER SUPPORT

SHARE COMMUNICATION PLAN

Team 1 Tasks - 1) Safety - CDASH & SDTM initially then all applicable CDISC production standards prepared for EVS inclusion. 2) Efficacy - TB & Cardiovascular standards initially and then all applicable CDISC therapeutic area production standards prepared and included in the NCI thesaurus (NCIt).

Line denotes contingency on NCI project milestones and deliverables.

Team 2 Tasks - 1) Refine requirements and send to NCI in 2 packages (high-level Requirements and detailed requirements). 2) Establish governance for entering CDISC production standards into NCIt and refine draft governance.3) Develop a metadata model for the creation of multi-dimensional date elements.

All new CDISC safety and efficacy production standards entered into the NCIt post the CDISC consensus process

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All new CDISC safety and efficacy production standards entered into the NCIt post the CDISC consensus process.

Rhonda Facile , CDISC

Next StepsNext Steps

�• Complete CDISC SHARE use cases and 1st phase ofComplete CDISC SHARE use cases and 1 phase of requirements (high level)

�• Continue gathering and refining requirements�• Continue gathering and refining requirements throughout 2010 and beyond

Ali i ti CDISC t d d CDASH SDTM�• Align existing CDISC standards �– CDASH, SDTM, BRIDG, Controlled Terminology

�• Continue developing new disease-specific standards �– Infectious Diseases, Cardiovascular Disease, Oncology, Neurological Disorders

�• Accelerate CDISC standards development process

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Strength through collaboration.

As a catalyst for productive collaboration, CDISC brings together individuals spanning the healthcare continuum to developindividuals spanning the healthcare continuum to develop

global, open, consensus-based medical research data standards.

Special Thanks to: Margaret Haber (NCI EVS), Erin Muhlbradte (NCI EVS), Rhonda Facile (CDISC), Dave Iberson-Hurst (CDISC)

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