Udo Siegmann member of e3c, CDISC Sen. Dir. Acc. Management PAREXEL

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1 Innovative Medicines Technological Platform Udo Siegmann member of e3c, CDISC Sen. Dir. Acc. Management PAREXEL

2 Facts about PAREXEL Full service CRO (Clinical Research Organisation) Involved in more than 500 clinical trials (Phase I IV) per year Annual Revenue 600+ MIO $ WW employees Offices in 36 countries 55% of staff and revenue in Europe > 1000 employees in data management and statistics

3 The Clinical Pharmacology International Network Total Beds 380+ Poitiers (France) Bioanalytical Laboratories London (UK) 40 beds Berlin Berlin (Germany) 165 beds Berlin Baltimore (USA) 52 beds George (SA) 32 beds Bloemfontein (SA) 90 beds & Bioanalytical Labs

4 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)

5

6 The Current State of Data Transfer in Clinical Trials Medical Records CRO CRF C Operational Data Pharma Submission Operational Data Submission Data Lab

7 Academic research Medical Records Site 1 CRF C Operational Data Site 2 Analylsis/ Publication Operational Data Submission Data Lab

8 Clinical Data Interchange Standards Consortium CDISC is an open, multidisciplinary, non-profit organization committed to the development of worldwide industry standards to support the electronic acquisition, exchange, submission and archiving of clinical trials data and metadata for medical and biopharmaceutical product development. The CDISC mission is to lead the development of global, vendor-neutral, platform-independent standards to improve data quality and accelerate product development in our industry.

9 CDISC Standard Description Implementation Version Release Date SDTM, SEND ODM LAB ADaM Protocol Representation Terminology Codelists Define.xml Ready for regulatory submission of CRT >6,000 downloads; > 600 companies in >53 countries CDISC Transport Standard for acquisition, exchange, submission (define.xml) and archive Content standard available for transfer of clinical lab data to sponsors General Considerations document and examples of datasets for submission Collaborative effort to develop machine-readable standard protocol with data layer Developing standard terminology to support all CDISC standards Case Report Tabulation Data Definition Specification 2004* 2001* In progress In progress 2005 * Production Standard * Specification in FDA Guidance

10 FDA Reference to CDISC Standards as Study Data Specifications for FDA Final Guidance

11 Data Flow Using CDISC = ODM (transport) = SDTM and Analysis Data (content) = Protocol information (content) = Source data (other than SDTM/CRF data) Protocol Representation Trial Design (SDTM) Analysis Plan ODM XML Patient Info Clinical (CRF or ecrf) Trial Data (defined by SDTM) ODM XML Administrative, Tracking, Lab Acquisition Info CRF, Analysis Data ODM XML Define.xml Integrated Reports SDTM Data, Analysis Data, Metadata Clinical Trial Protocol (e)source Document Operational & Analysis Databases Regulatory Submissions

12 Where the CDISC Standards are Applied Study Start-up Study Conduct Analysis/Reporting Submission SCTP ODM SDTM ODM LAB SDTM ODM SDTM ADaM ODM SDTM ADaM Define.xml SCTP = Structured Clinical Trial Protocol ODM = Operational Data Model SDTM = Study Data Tabulation Model (Note: includes SEND, as applicable SEND = Standard for the Exchange of Non-clinical Data ADaM = Analysis Dataset Model

13 Interoperability Main Entry: in ter op er a bil i ty : ability of a system... to use the parts or equipment of another system Source: Merriam-Webster web site interoperability : ability of two or more systems or components to exchange information and to use the information that has been exchanged. Source: IEEE Standard Computer Dictionary: A Compilation of IEEE Standard Computer Glossaries, IEEE, 1990] Syntactic interoperability Semantic interoperability Source: Charlie Mead, MD, HL7

14 The mission of CDISC is to develop and support global, platformindependent data standards that enable information system interoperability to improve medical research and related areas of healthcare.

15 Today s Clinical Research Environment More intense focus on patient safety and pharmacovigilance Need for transparency of clinical information through publicly 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)

16 The BRIDG Model* 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

17 Health Level Seven (HL7) The world s leading standard for the electronic interchange of healthcare information >20 Global affiliates 16 years of operation American National Standards Institute (ANSI)-accredited Standards Development Organization (SDO);also, ISO standard Acknowledged by the Department of Health and Human Services (HHS) as the standard for healthcare information exchange

18 Rolling Warehousing, Reporting and Submissions Vision Medical Innovation Data Sources Regulatory Authority EDC Public Registries and IRBs EHR CDISC Standards Real-time Integration Sponsor ECG X-RAY LAB Payer CRO or Partner Subject Data Enter Once for Multiple Purposes

19 Industry Advisory Board CDISC Board of Directors Board Committees Financial Oversight Governance Nominating Scientific Technical Support & Guidance CDISC Working and Support Teams Operational Data Modeling (ODM) Submission Data Standards (SDS) Analysis Data Set Modeling (ADaM) Laboratory Data (LAB) Protocol Representation SEND Terminology Alliances HL7 Others CDISC Regional Groups Regional CDISC Coordinating Committees (r3c) Regional CDISC Groups r = regions, including Europe, Japan, India Operations and Infrastructure (OIS) Education Membership Services PR/Communications Operations and Financial Management Technical Direction; TCC Implementation Group Coordination Standards Maintenance Glossary Group Leadership

20 Global Activities

21 Global CDISC Activities Europe CDISC Coordinating Committee (E3C) Initiated 2002 in Frankfurt ~40 companies represented from ~ 10 countries 1 st CDISC Interchange Brussels, May 2004 (speakers from FDA and EMEA); 2 nd -Interchange Paris, April 2005, 3rd -Interchange Berlin, April 2006, 4th -Interchange Montreux, April 2007

22 CDISC grows in Europe EU Interchange Attendee Count Attendees Brussels 2004 Paris 2005 Berlin 2006 Montreux 2007 Interchange 2008 Target: 225 Attendees

23 e3c,becky Kush (President), Dave Hardison (chairman of board)

24 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 adopting standards for EHR Interaction with Health Level 7 representatives within Europe Support CDISC user groups

25 J3C and Japan CDISC Group Japan CDISC Coordinating Committee (J3C) and Japan 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 Tokyo (120 participants)

26 Corporate Sponsors

27 Corporate Members / Associate Members

28 Information and Contacts For standards and information, see enewsletters available via ; contact Shirley Williams or sign up on the CDISC website. Technical questions: Julie Evans or Public Discussion Forum Education and Membership: Frank Newby

29 Backup /CDISC Collaborations

30 Insurance Claims Healthcare Delivery Patient Information Treatment, Insurance Medical Records Paper Charts EMR Basic Clinical Research Investigator-Sponsored Data Acquisition, Analysis Lab Notebooks, Files Protocol-driven Clinical Trials Biopharmaceutical Industry-Sponsored Data Acquisition, Analysis Multiple databases EDC, CDMS, CTMS SAE Publications Regulatory Drug Approval

31 CDISC Principles Maintain a global, multidisciplinary, crossfunctional composition for CDISC and its working groups. Work with other professional groups to encourage that there is maximum sharing of information and minimum duplication of efforts. Provide educational programs on CDISC standards, models, values and benefits. Accomplish the CDISC goals and mission without promoting any individual vendor or organization.

32 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

33 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 archive requirements HL7 Healthcare information exchange standards and methodology; accreditation process

34 CDISC in the World of Standards 2000 ICH EU EMEA US FDA Japan MHW Health Care Providers & Pharmacies REGULATORY AUTHORITIES SDS ODM ADaM LAB Clinical Trials Pharmaceutical Industry EU USA Japan EFPIA PhRMA JPMA Standards: HL7, XML Models: NCI, OMG, RIM Dictionaries: MedDRA, LOINC

35 CDISC in the World of Standards Today International Conference on Harmonization (ICH) EFPIA EMEA JPMA MHLW KIKO U.S. FDA Protocol Std TC: RCRIM CDISC PhRMA U.S. Dept. of Health and Human Services (HHS) DICOM CDC Health Level 7 (HL7) NIH/NCI ISO NLM MedDRA ectd ADaM SDS ODM LAB Reference Information Model RIM Clinical Document Architecture LOINC SNOMED = Organization = Dictionary, Codelist = Standard = Model = Document Standard, or Architecture

36 Interoperability Main Entry: in ter op er a bil i ty : ability of a system... to use the parts or equipment of another system Source: Merriam-Webster web site interoperability : ability of two or more systems or components to exchange information and to use the information that has been exchanged. Source: IEEE Standard Computer Dictionary: A Compilation of IEEE Standard Computer Glossaries, IEEE, 1990] Syntactic interoperability Semantic interoperability Source: Charlie Mead, MD, HL7

37 Towards interoperability.. HL7 Reference Information Model (RIM) V3 Designed for healthcare Problem Space (Domain) Model Developed for for Clinical Research CDISC Models

38 End-to-End Seamless Integration Open Data Model - XML based, CDISC compliant Pharma SDTM Investigator Protocol ODM LAB Operational Database SDTM ADaM Patients Subject Approval Physician Medical & Statistical Reviewers Slide designed by D. Iberson-Hurst, Assero

39 Insurance Claims Basic Clinical Research Healthcare Delivery Patient Information Investigator-Sponsored Data Acquisition, Analysis Protocol-driven Clinical Trials Biopharmaceutical Industry-Sponsored Data Acquisition, Analysis Publications Regulatory Drug Approval

40 The End Thank you very much

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