Udo Siegmannmember of e3C, CDISC

Sen. Dir. Acc. ManagementPAREXEL

Innovative Medicines Technological Platform

• Full service CRO (Clinical Research Organisation)

• Involved in more than 500 clinical trials (Phase I – IV) peryear

• Annual Revenue 600+ MIO $

• WW employees 5000+

• 57 Offices in 36 countries

• 55% of staff and revenue in Europe

• > 1000 employees in data management and statistics

Facts about PAREXEL

The Clinical Pharmacology International Network

Poitiers (France)Bioanalytical Laboratories

London (UK) – 40 beds

Baltimore (USA) – 52 beds

Bloemfontein (SA) – 90 beds& Bioanalytical Labs

Berlin (Germany) – 165 beds

Berlin

Berlin

George (SA) – 32 beds

Total Beds 380+

Goals for this session• Learn about the history and latest development of CDISC

• Be able– to ask questions about CDISC contents and organization– to better understand CDISC and predict upcoming CDISC developments– to better predict the impact of CDISC into our daily work in the future

• For your organization, discuss and evaluate– how and where CDISC could be implemented/adressed globally within the

organization– how we want to contribute / to benefit from CDISC

• Discuss, what will be the impact of CDISC on– Regulated trials => submission data model– Data Management data bases => operational data model– Handling of electronic lab data (lab data model)

The Current State of Data Transfer in Clinical Trials

Lab

SubmissionData

Submission

MedicalRecords

OperationalData

CRO

OperationalData

Pharma

CCRF

Academic research

Lab

SubmissionData

Analylsis/Publication

MedicalRecords

OperationalData

Site 1

OperationalData

Site 2

CCRF

Clinical Data InterchangeStandards Consortium

CDISC is an open, multidisciplinary, non-profitorganization committed to the development ofworldwide industry standards to support theelectronic acquisition, exchange, submission

and archiving of clinical trials data and metadatafor medical and biopharmaceutical product

development.The CDISC mission is to lead the development of

global, vendor-neutral, platform-independentstandards to improve data quality and accelerate

product development in our industry.

2005 *Case Report Tabulation Data DefinitionSpecification

Define.xml

Developing standard terminology to support allCDISC standards

Collaborative effort to develop machine-readablestandard protocol with data layer

General Considerations document and examplesof datasets for submission

Content standard – available for transfer of clinicallab data to sponsors

CDISC Transport Standard for acquisition,exchange, submission (define.xml) and archive

Ready for regulatory submission of CRT>6,000 downloads; > 600 companies in >53countries

Description

In progressProtocolRepresentation

In progressTerminologyCodelists

2004ADaM

2002LAB

2001*ODM

2004*SDTM, SEND

ImplementationVersion Release Date

CDISC Standard

* Specification in FDA GuidanceProduction Standard

FDA Reference to CDISC Standards asStudy Data Specifications for FDA Final Guidance

Data Flow Using CDISC

SDTM Data,Analysis

Data,Metadata

CRF, Analysis Data

RegulatorySubmissions

(e)SourceDocument

Operational & Analysis

Databases

Patient Info

Clinical (CRF or eCRF)

Trial Data(defined by

SDTM)

ODMXML

ODM XMLDefine.xml

ODMXML

Administrative,Tracking, Lab Acquisition Info

IntegratedReports

Trial Design (SDTM)

Analysis Plan

Clinical Trial Protocol

ProtocolRepresentation

= SDTM and Analysis Data (content)

= ODM (transport)

= Protocol information (content)

= Source data (other than SDTM/CRF data)

SCTPODMSDTM

ODM LAB SDTM

ODM SDTM ADaM

Study Start-up Study Conduct Analysis/Reporting

ODMSDTMADaM

Define.xml

Submission

Where the CDISC Standards are Applied

SCTP = Structured Clinical Trial ProtocolODM = Operational Data ModelSDTM = Study Data Tabulation Model (Note: includes SEND, as applicableSEND = Standard for the Exchange of Non-clinical DataADaM = Analysis Dataset Model

Interoperability• Main Entry: in·ter·op·er·a·bil·i·ty

: ability of a system ... to use the parts orequipment of another system

Source: Merriam-Webster web site

• interoperability : ability of two or more systems or components toexchange information and to use the informationthat has been exchanged.

Source: IEEE Standard Computer Dictionary: A Compilation ofIEEE Standard Computer Glossaries, IEEE, 1990]

Semanticinteroperability

Syntacticinteroperability

Source: Charlie Mead, MD, HL7

The mission of CDISC is to developand support global, platform-

independent data standards thatenable information system

interoperabilityto improve medical research and

related areas of healthcare.

Today’s Clinical Research Environment

• More intense focus on patient safety andpharmacovigilance

• Need for transparency of clinical information throughpublicly accessible registries and databases– WHO trial registry, FDA Janus DB

• Increasing focus on electronic healthcare records• Importance of interoperability among partners• Drive to accelerate development cycle and improve

success rates• Ability to make rapid decisions based on study data

(adaptive clinical trials)

A clinical research domain analysis model initiated by CDISC,

BRIDGing •Organizations (CDISC, HL7, FDA….)•Standards •Research and Healthcare

*Biomedical Research Integrated Domain Group (BRIDG) Model

The BRIDG Model*

• The world’s leading standard for theelectronic interchange of healthcareinformation– >20 Global affiliates– 16 years of operation

• American National Standards Institute(ANSI)-accredited Standards DevelopmentOrganization (SDO);also, ISO standard

• Acknowledged by the Department of Healthand Human Services (HHS) as the standardfor healthcare information exchange

Health Level Seven (HL7)

Vision – Medical Innovation

CRO or Partner

EDC

LAB

ECG

X-RAY

Sponsor

Regulatory Authority

“Rolling” W

arehousing, Reporting and Subm

issionsSubj

ect D

ata

– En

ter O

nce

for M

ultip

le P

urpo

ses

Payer

EHR

Public Registries and IRBs

Data Sources

CDISC StandardsReal-time Integration

•Regional CDISC Coordinating Committees (r3C)•Regional CDISC Groups

r = regions, including Europe, Japan, India…

AlliancesCDISC Working andSupport Teams

•Operational Data Modeling (ODM)•Submission Data Standards (SDS)•Analysis Data Set Modeling (ADaM)•Laboratory Data (LAB)•Protocol Representation•SEND•Terminology

Board Committees•Financial Oversight•Governance•Nominating•Scientific•Technical Support & Guidance

Operations and Infrastructure (OIS)

•Education •Membership Services•PR/Communications •Operations and Financial Management

•Technical Direction; TCC•Implementation Group Coordination•Standards Maintenance•Glossary Group Leadership

CDISC Regional Groups

Industry Advisory Board

CDISC Board of Directors

•HL7•Others

Global Activities

Global CDISC Activities

• Europe CDISC Coordinating Committee (E3C)– Initiated 2002 in Frankfurt– ~40 companies represented from ~ 10 countries– 1st € CDISC Interchange Brussels, May 2004

(speakers from FDA and EMEA);– 2nd €-Interchange Paris, April 2005,– 3rd €-Interchange Berlin, April 2006,– 4th €-Interchange Montreux, April 2007

CDISC grows in Europe

EU Interchange Attendee Count

100109

139

184

020406080

100120140160180200

Brussels 2004 Paris 2005 Berlin 2006 Montreux 2007

Interchange

Att

ende

es

2008 Target:225

Attendees

e3C ,Becky Kush (President), Dave Hardison (chairman of board)

E3C Responsibilities• Organisation of the annual European

Interchange• Training and seminars in European countries• Contact with EMEA and national competent

authorities.• Liaison with European health authorities with

particular emphasis on those adoptingstandards for EHR

• Interaction with Health Level 7 representativeswithin Europe

• Support CDISC user groups

J3C and Japan CDISC Group

• Japan CDISC Coordinating Committee (J3C) andJapan CDISC Group (JCG)includes representatives of more than 40

companies operating in Japan– Meetings with MHLW, KIKO in 2003– Presentations and Training annual– Interchange started in 2004

• 2007 Tokyo (120 participants)

Corporate Sponsors

Corporate Members / Associate Members

Information and Contacts• For standards and information, see www.cdisc.org• eNewsletters available via e-mail; contact Shirley

Williams swilliams@cdisc.org or sign up on theCDISC website.

• Technical questions: Julie Evans jevans@cdisc.orgor Public Discussion Forum

• Education and Membership: Frank Newbyfnewby@cdisc.org

• Udo.siegmann@parexel.com

Backup /CDISC Collaborations

HealthcareDelivery

Patient InformationTreatment, Insurance

Basic ClinicalResearch

Investigator-SponsoredData Acquisition,

Analysis

Lab Notebooks, Files

Insurance Claims

Protocol-driven Clinical Trials

BiopharmaceuticalIndustry-Sponsored

Data Acquisition, AnalysisMultiple databases

EDC, CDMS, CTMSSAE…

Publications

RegulatoryDrug Approval

MedicalRecords

Paper ChartsEMR

CDISC Principles• Maintain a global, multidisciplinary, cross-

functional composition for CDISC and its workinggroups.

• Work with other professional groups to encouragethat there is maximum sharing of information andminimum duplication of efforts.

• Provide educational programs on CDISCstandards, models, values and benefits.

• Accomplish the CDISC goals and mission withoutpromoting any individual vendor or organization.

Collaborations• Drug Information Association

– eClinical SIAC– Fall Conference (October 2004)

• Controlled Terminology Task Force (NIH/NCI,VA, FDA, DCRI)

• U.S. CDM Group (SCDM)• Europe (EMEA and CDM Groups: DMB, ACDM,

INCDMA)• Japan (KIKO, MHLW, JPMA)• Australian CDM/Statistics Group (ARCS)• Health Level Seven (HL7) – FDA, CDISC, HL7

CDISC, FDA, HL7• Shared Purpose

– To improve the quality of public health– To have one overarching standard model for data interchange for

• healthcare information– and

• clinical trial/clinical research data

• Domain Expertise Contributions– CDISC and FDA

• Regulated clinical research data acquisition, review and archiverequirements

– HL7• Healthcare information exchange standards and methodology;

accreditation process

Standards:HL7, XML

Dictionaries:MedDRA, LOINC

Clinical Trials

CDISC in the “World of Standards” 2000

USFDA

EUEMEA

JapanMHW

REGULATORY AUTHORITIES

Health C

are Providers

& P

harmacies

Models:NCI, OMG, RIM

ICH P

harm

aceu

tica

l Ind

ustr

y

EU

US

A

Ja

pan

EFP

IA

PhR

MA

JP

MA

SDS ODM

ADaM LAB

Protocol Std

ClinicalDocument

Architecture

DICOM

ADaM

CDISC in the “World of Standards” TodayInternational Conference on

Harmonization (ICH) U.S. Dept. of Health and Human Services(HHS)

Health Level 7 (HL7)

U.S. FDA

CDISCTC:

RCRIM

NIH/NCI NLM

EFPIA

EMEA MHLWKIKO

PhRMAJPMA

CDC

Reference Information Model

RIM

LAB

eCTD

LOINC

ISO

SNOMEDMedDRA

ODMSDS

= Organization= Dictionary, Codelist = Standard = Model

= Document Standard, or Architecture

Interoperability• Main Entry: in·ter·op·er·a·bil·i·ty

: ability of a system ... to use the parts orequipment of another system

Source: Merriam-Webster web site

• interoperability : ability of two or more systems or components toexchange information and to use the informationthat has been exchanged.

Source: IEEE Standard Computer Dictionary: A Compilation ofIEEE Standard Computer Glossaries, IEEE, 1990]

Semanticinteroperability

Syntacticinteroperability

Source: Charlie Mead, MD, HL7

Towards interoperability…..

HL7 ReferenceInformation Model(RIM) V3

Designed for healthcare

HL7 ReferenceInformation Model(RIM) V3

Designed for healthcareProblem Space

(Domain) ModelDeveloped for Clinical

Research

Problem Space(Domain) Model

Developed for ClinicalResearch

CDISC Models

End-to-End Seamless Integration

Pharma

Medical & StatisticalReviewers

Approval

Open Data Model - XML based, CDISC compliant

Patients

Subject

OperationalDatabase

Investigator ODM SDTM

Physician

Slide designed by D. Iberson-Hurst, Assero

SDTM

LAB ADaM

Protocol

Insurance Claims

Biopharmaceutical Industry-SponsoredData Acquisition,

Analysis

Publications

RegulatoryDrug Approval

Protocol-driven Clinical Trials

Basic Clinical Research

Investigator-Sponsored Data Acquisition,

Analysis

Healthcare Delivery

Patient Information

The End

Thank you very much