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CDISC and FDA Initiatives in the World of Standards

This presentation explores the progress made by CDISC in developing data standards for the pharmaceutical industry. It discusses the harmonization of CDISC standards with other organizations and the global adoption of these standards. The presentation also highlights the relationship between CDISC and Health Level 7 (HL7) and the future evolution of CDISC standards.

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CDISC and FDA Initiatives in the World of Standards

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  1. Japan CDISC Group (JCG) Presentation 28 January 2004 Rebecca Kush, PhD Founder and President

  2. Central CDISC Progress 2003 R.Kush 14:10-14:25 CDISC and FDA Initiatives R. Kush, J. Evans 14:25-14:45 (including CDISC-HL7-FDA–RCRIM)

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

  4. CDISC in the “World of Standards” 2003 International Conference on Harmonization (ICH) U.S. Dept. of Health and Human Services (HHS) EFPIA JPMA PhRMA EMEA MHLW KIKO U.S. FDA CDC NIH/NCI NLM TC: RCRIM DICOM Protocol Std ISO CDISC Health Level 7 (HL7) ADaM SDS ODM LAB Reference Information Model RIM LOINC MedDRA SNOMED Clinical Document Architecture eCTD = Dictionary, Codelist = Document Standard, or Architecture = Organization = Standard = Model

  5. Interchange Standards: Long-term Desired Outcomes • A holistic approach to standards, facilitating data interchange from sites through regulatory submission, utilizing XML • Standards for data acquisition supporting the population of a cross-trial warehouse within FDA • HL7-CDISC models harmonized to yield value for both clinical research and healthcare – sharing of information between EMR and clinical trials • Global adoption of CDISC data standards CDISC Meeting with FDA Commissioner, April 2003

  6. CDISC 2003 - Highlights • Progress in Standards Development (Julie) • New View of “CDISC in the World of Standards” • Harmonization of the CDISC Standards • Standards Adoption • Global Expansion • Education and Membership • Collaboration:CDISC-Health Level 7 Relationship

  7. Harmonization

  8. Evolution of CDISC Standards Future Uniform Standard Operational Data Interchange & Archive: ODM, LAB Submission Data Interchange & Archive: SDS, ADaM • Data Sources • Site CRFs • Laboratories • Contract • Research • Organizations • Development • Partners • Operational • Database • Study Data • Audit Trail • Metadata • Submission • Data • CRT/Domain Datasets • Analysis Datasets • Metadata ODM = Operational Data Model/Std SDS = Submission Domain Standards LAB = Laboratory Data Model/Std ADaM = Analysis Data Models

  9. Operational Data Modeling Submission Data Modeling Regulatory Reviewers Data Sources ODM values can be expressed via SDS metadata • ODM • Operational Data Model • XML format for clinical study • data and metadata • Supports regulatory-compliant • e-Archive format • SDS • Submission Data Standards *Describes content, structure and attributes of data for regulatory submissions *Defines metadata content for standard domains *Facilitates regulatory reviews • LAB • Laboratory • Data Model • Defines standard content for • transferring clinical laboratory data from • Labs to sponsors • ASCII, SAS, XML, and • HL7 implementations available Applies submission model for analysis datasets LAB data can be mapped into ODM XML • ADaM • Analysis • Dataset Models • Provides models for commonly used statistical analyses. ODM can be used to represent and archive submission data

  10. Adoption of Standards

  11. CDISC-CenterWatch Research Project on Technology and Standards Adoption • Sponsored by 24 companies • Lengthy questionnaires • Posted in August-September 2002 • 750 respondents in four categories • Sponsor – 211 (80% US) • CRO/Service Provider – 146 (90% US) • Technology Provider – 38 (75% US) • Site Personnel – 355 (94% US) • Conducted again with emphasis in Japan, Europe and Latin America – September 2003

  12. N. American Implementation of CDISC Data Models by Pharma Companies 2002 Results; Respondents, n=750, Pharma companies, n=211

  13. CDISC-CenterWatch Research Project – International Reach 2003 • International Total n = 361 • Sponsor (BioPharma): n = 89 • Service Providers (CROs): n = 43 • Technology Providers: n = 13 • Sites: n = 216 • Regions: • Sponsors: 51% Europe; 22% Japan; 27% Latin America, Other • Service Providers: 73% Europe; 5% Japan; 22% Latin America, Other • Sites: 73% Europe; 14% Latin America; 21% Japan, Other

  14. 2002-2003 Regional Comparisons Perceived Importance of Standard Models for Efficient Interchange of Data Percent Agree * CDISC-CenterWatch 2003 International Survey Q29 BioPharma, 2003 International Survey Q33 CRO * CDISC-CenterWatch 2002 N. American Survey Q29 BioPharma, 2002 N. American Survey Q33 CRO

  15. 2002-2003 Regional Comparisons “Standards should be extended to facilitate data collection at investigative sites” Percent Agree * CDISC-CenterWatch 2003 International Survey Q30 BioPharma, 2003International Survey Q34 CRO * CDISC-CenterWatch 2002 N. American Survey Q30 BioPharma, 2002 N. American Survey Q34 CRO

  16. International Implementation of CDISC Data Models by Pharma Companies 2003 Results; Respondents, n=361, Pharma companies, n= 89

  17. Objectives for CDISC Model Adoption • Complete/harmonize CDISC Standards and have them incorporated into FDA Guidance documents • Obtain HL7 accreditation for clinical data interchange standards • Ensure compatibility of clinical research standards with healthcare standards • Continue development of standards support the ‘front-end’ and other points in the process (i.e. protocols, eSource documents, terminology) • Enhance and strengthen partnerships • Support standards implementation/usage globally and ensure maintenance mechanisms

  18. Vendors must Recognize that clinical technology uptake is limited by poor integration capabilities Add support for import and export using ODM Continue to support CDISC Sponsor should Request clinical data transfers in CDISC format (CROs, EDC vendors, clinical labs) Use CDISC formats in internally developed applications Continue to support development and enhancement of standard models Adopting ODM and other CDISC Standards

  19. Global Expansion

  20. Global CDISC Activities • Japan CDISC Coordinating Committee (J3C) and Japan CDISC Group (JCG) - Topic of 28 January Meeting • India CDISC Coordinating Committee (I3C) • Initiated mid-2003 with I3C meeting • December presentations for academic conference • International Symposium on CLINICAL DATA MANAGEMENT • Institute of Bioinformatics & Biotechnology, University of Pune, Pune, India • Europe CDISC Coordinating Committee (E3C) and Europe CDISC Group (ECG) – Initiated 2002 • ~40 companies represented from ~ 10 countries • Communicating with EMEA to encourage collaboration on requests for data in EUDRACT Guidance; Protocol Representation standards harmonization • Regular newsletter in German; working with DMB in France, ACDM in UK and INCDMA in Europe and Australia

  21. e3C and European CDISC Group • Leader: Udo Siegmann, PAREXEL • e3C ~ 8 individuals leading working groups focused on: • Regulatory • Education • Membership • PR/Communications • Case Studies • European members on CDISC Teams; specific European ODM sub-team initiated in May 2003; active participation on CDISC Technical Coordinating Committee • EU CDISC Interchange scheduled for 9-12 May 04 near Brussells

  22. CDISC Membership and Education

  23. CDISC Interchange-Highlights29 September – 2 October 2003, Bethesda, MD • Team Meetings – Separate and Joint • Tutorials (3): Introduction, ODM, SDS V3 • Workshops (4) • Conference • Opening Keynote Presentation by Mark B. McClellan, MD, PhD, FDA Commissioner • The State of the Industry and the State of CDISC • Use of the CDISC Collaborative Standards Forum • Global CDISC Activities • The Future of Technology by Alpheus Bingham, Eli Lilly • Updates and Case Studies on the CDISC Standards • FDA Public Meeting on Results of SDS V3 Pilot • CDISC Industry Advisory Board Meeting

  24. I think CDISC is an important part of this broader vision. The standards that you are developing, and the flow of information it will enable, will inform everything we do. It will certainly make more robust our systems for evaluating new drug applications, but it will do much more. With the construction of smart data repositories that your standards will enable, the information we collect and the knowledge we glean from it will be made more enduing, more usable, and more accessible to patients and doctors. • I’m well aware that implementing IT systems remains a challenging objective. But you’ve found a way to come together and solve some of the biggest challenges we face; your success here will be a model for how these things can get done. • Mark B. McClellan, MD, PhD, FDA Commissioner

  25. Education • Current Courses • CDISC Introduction and Overview • ODM & LAB • SDS v3 & ADaM • Seminars • Public and Private • Future Courses • Ensuring Conformity to CDISC Standards • CD-ROM / WEB-based Training

  26. Membership

  27. Membership

  28. Membership

  29. Membership • Increase in Membership since September 2002 • Overall 42% increase • Associate Membership up 53% • Corporate Membership up 145% • Corporate Sponsorship up 20%

  30. Collaborations • Drug Information Association • eClinical SIAC • Fall Conference • Controlled Terminology Task Force • Europe (DMB, EMEA, ACDM, INCDMA) • Japan • Australia – ARCS • Society of Clinical Data Management • Others

  31. Collaboration of CDISC with Health Level Seven (HL7)

  32. CDISC Principles • Lead the development of standard data models that improve process efficiency while supporting the scientific nature of clinical research. • Recognize the ultimate goal of creating regulatory submissions that allow for flexibility in scientific content and are easily interpreted, understood, and navigated by regulatory reviewers. • Acknowledge that the data content, structure and quality of the standard data models are of paramount importance, independent of implementation strategy and platform.

  33. CDISC Principles • Maintain a global, multidisciplinary, cross-functional 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.

  34. 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 standards • Acknowledged by the Department of Health and Human Services (HHS) as the standard for healthcare information exchange

  35. Benefits of CDISC-HL7 Alliance Capitalizes on HL7 standards development experience base Leverages HL7 accreditation and HHS acknowledgement as SDO; FDA support Expands value and influence of clinical trials standards efforts through harmonization Provides opportunity for common informatics platform for healthcare and clinical research

  36. HL7 Regulated Clinical Research and Information Management (RCRIM) Technical Committee Initiated as Clinical Trials SIG in Jan 2001 RCRIM TC approved in April 2002 • Develops common standards for clinical research and regulatory evaluation • Assures that other HL7 standards (healthcare standards) can be used in regulated clinical research • Co-chaired by FDA (R. Levin), HL7/Pharma (L. Quade) and CDISC (B. Tardiff) Joint Leadership: HL7, CDISC,FDA Active Membership: FDA, CDISC,HL7 & others Patient Safety SIG Genomics SIG

  37. RCRIM: Current Initiatives • Research Process • Standardized representation of clinical trial protocol • Research Data • Periodic reporting of clinical trial laboratory data • Annotation of ECGs • Clinical trial data for regulatory submission (Informative Doc) • Define.xml (Informative Doc) • Non-clinical data for regulatory submissions (SEND) Regulatory Information Structured Product label eStability data Surveillance Individual Patient SafetyReports (eMedWatch) HL7 Ballots Approved • Direct CDISC Involvement

  38. “Working group” e.g. CDISC, FDA, RCRIM Proposed standard HL7 Membership Accredited Standard RCRIM Draft FDA Guidance Final FDA Guidance FDA Public HL7 RCRIM Standards Process Flow

  39. CDISC and RCRIM Standards(Collaborative Groups ~ FDA, CDISC, HL7, SEND, CDC, NIH, LOINC, etc.) HL7 Reference Information Model RIM Regulated Clinical Research Information Management Technical Committee HL7 RCRIMTC V3 RIM V3 RIM V3 RIM V3 RIM CDA CDA Inf.Doc Inf.Doc Inf.Doc Inf.Doc Define.xml Protocol Elements ADaM SDS ODM LAB ECG Patient Safety Report Product Label eStability Data SEND Non-Clin SDS CDISC FDA Collaborative Groups

  40. Next Steps • Based upon presentation from CDISC to HL7 Board on 9 September 2003 • Unanimous Decisions of HL7 and CDISC Boards • CDISC-HL7 development of a business case supporting incentives to joint membership and renewal of HL7-CDISC Associate Charter Agreement • Formation of a study group to assess how the CDISC standards might become RIM compliant and be grafted onto HL7 RIM Version 3 • CDISC Board approval on 3 October

  41. Shared Purpose; Separate Contributions • Shared Purpose (CDISC, FDA/HHS and HL7) • 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 • CDISC, FDA and the Pharmaceutical Industry – Regulated clinical research data acquisition, review and archive requirements • HL7 – Healthcare information exchange standards and methodology; accreditation processes

  42. Opportunities for CDISC Members • Attendance at HL7 Working Group Meetings and Tutorials (3x/yr) • CDISC members have membership privileges in HL7 for WGM • Additional co-membership opportunities forthcoming • Implementation Activities • Participation in HIMSS HL7 demo (hands on ‘laboratory’) • Potential to repeat demo for DIA • Use of the CDISC HL7 message for clinical laboratory data and ECG waveform message • Proof-of-Concept (Single Source) Project

  43. Proof-of Concept Project (Single Source) • Designed to demonstrate compatibility between HL7 RIM-derived Clinical Document Architecture (CDA) and CDISC Operational Data Model (ODM) • Single source entry for medical records and clinical trials • eSource documentation contributes to patient chart, not the reverse (i.e. extraction from EMR); reduces regulatory issues • Minimizes redundancy in data entry, thus improving data integrity/quality • Can potentially be driven from electronic protocol • First stage POC initiated through Duke Hospital and Duke Clinical Research Institute • Have commitments from four technology partners, an academic institution and an academic research organization; currently garnering pharmaceutical support for this breakthrough project

  44. Single Source Proof-of-Concept eSource Single Source ePatient Record CDA ODM Clinical Database • Leverages healthcare (HL7) and research (CDISC) data interchange standards; tool interoperability • Facilitates investigator workflow; eliminates transcription steps • Compliance with 21CFR11 and HIPAA feasible • Enables online monitoring

  45. eProtocol/SAP eSource Single Source ePatient Record CDA ODM CRT/Analysis Datasets Define.xml • Leverages healthcare (HL7) and research (CDISC) data interchange standards; tool interoperability • Facilitates investigator workflow; eliminates transcription steps • Compliance with 21CFR11 and HIPAA feasible • Enables the protocol (PLAN) to drive the entire process

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

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

  48. Information and Contacts • For standards and information, see www.cdisc.org • Quarterly updates available via e-mail; contact Shirley Williams swilliams@cdisc.org • Technical questions: Julie Evans jevans@cdisc.org or Public Discussion Forum • Education and Membership: Frank Newby fnewby@cdisc.org • Rebecca Kush: rkush@cdisc.org

  49. Backup Slides

  50. Single Source: Potential Flow for Clinical Trial Data HL7 Messaging CDISC ODM Interchange Maps to CDA, includes ODM support of Regulated Clinical Research data interchange and archive; uses SDS metadata CDISC SDS HL7 CDA EMR Database FDA Submission Database Clinical Trial eSource Document (w/ required CRF fields identified) eCRF Data (Document) Operational Database @Sponsor eVerification/Audit Data Entry [or Dictation] by Investigator or CRC Hospital Lab data Central LAB Data Transfers

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