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1 B B- Pfizer Inc. B- FDA (NCI) B- B- B- SAS SAS Institute Inc.

2 B Pfizer Inc. CDISC Pfizer Global Research & development, Pfizer's Groton site, CT, U.S.A. William Rosen Donald J. Fish Mary E. Lenzen Executive Director Worldwide Regulatory Affairs & Quality Assurance Director Clinical Standards Development Informatics Associate Director, Clinical Data Standards Global Clinical Data Services IT Pfizer CDISC FDA NewsFDA Announces Standard Format That Drug Sponsors Can Use to Submit Human Drug Clinical Trial Data CDISC SDTM(Study Data Tabulation Model) 2006/2007 CDISC SDTM 6.1CDSIC 1

3 6.1.1 CDISC XML HTML CDSIC FDA CDSIC FDA Pfizer FDA Quality Check data FDA FDA reviewer 2 review 6.2 CDISC SDTM Benefits Cost/Risk 2

4 6.3 CDISC CRO QC 7 CDISC Pfizer CDISC FDA 3

5 B FDA (NCI) CDISC 1) NCI13:20-13:55 (Pfizer ) 2) FDA12:00-14:00 1) (NCINational Cancer Institute) National Cancer Institute Center for Bioinformatics, National Institutes of Health, Rockville, MD 20892, USA Telephone: ) (FDAU.S. Food and Drug Administration) U.S. Food and Drug Administration (White Oak) New Hampshire Avenue Bldg #22, Room 1311 Silver Spring, MD 20993, USA Telephone: ) NCI Brenda Duggan National Cancer Institute, Center for Bioinformatics (NCICB) 2) FDA Randy Levin, MD Stephen E. Wilson Justina Molzon, M.S. Pharm., J.D. Vikki Kinsey Director for Health and Regulatory Data Standards Director (Acting), Office of Business Process Support Associate Director, Office of International Programs Consumer Safety Officer, Office of Executive Programs 4

6 1) NCI (NIHNational Institutes of Health) NCI 1937 NCI ( 1)NCI Brenda Duggan NCI Center for Bioinformatics Center for Bioinformatics NCI NCI 2) FDA (HHS: Department of Health and Human Services) NCI 2007 FDA 5

7 FDA CDERCenter for Drug Evaluation and Research ( 2) 2. FDA 1) NCI NCI The Clinical Regulatory Information Exchange initiative (CRIX) CRIX 2003 NCI and FDA IOTF (Inter-Agency Operational Task Force) cabig (NCI cancer BioInformatics Grid) Guidelines CRIX Firebird (Federal Investigator Registry for Biomedical Informatics Research Data) SAFE ( Secure Access For Everyone ) 21 CRIX CDR (Clinical Data Repository) CRIX CDR CRIX 6

8 CDR Janus CDISC HL7 FDA Janus NCI FDA 3. CRIX CDR 2) FDA FDA EU ICH(International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use) NIH CDC HL7(Health Level Seven) ANSI CDISC (Clinical Data Interchange Standards Consortium) Observer RCRIM (Regulated Clinical Research Information Management) Thechnical Committee HL7 CDISC FDA ICH ectd (Electronic Common Technical Document) CDISC SDTM (Study Data Tabulation Model) Pfizer CDISC 7

9 4. FDA CDISC ( ) 5. FDA 8

10 FDA 5 Gateway CRT Document Share CRT WebSDM DataLoad NCI Janus Data Warehouse WebSDM Data Viewer ( PPV (Patient Profile Viewer) JMP ) IT 2005 HL7 SDO(Standards-developing Organization) HL7 NCI FDA HL7 HL7 ANCI ISO FDA CDISC FDA CDISC FDA CDISC FDA FDA NCI NCI NIH FDA NCI FDA 9

11 CDISC (Duke Clinical Research Institute, Duke University Medical Center) Duke Clinical Research Institute Room 0311 Terrace Level 2400 Pratt Street Durham, NC John H. Alexander, MD, MS Ralph Corey, MD Gail B. Fowler David J. Gressner Allison Handler, RN,MS,CCRC Marion W Jervay, JD Mitchell W Krucoff, MD, FACC,FCCP Justina A. Molzon, MS, Pharm, JD Deborah A Roth Jack Shostak, BS, MBA Assistant Professor of Medicine, Medicine and Cardiology Director of Infectious Disease Professor of Medicine and Infectious Disease Director of Site Management and Clinical Monitoring Professor, Medicine and Cardiology Head Therapeutic Development Project Leader, Clinical Operations Director, Strategic Development and Contract Management Director, Cardiovascular Devices Unit Associate Director for International Programs Clinical Operating Officer Statistical Programming Manager 10

12 (DCRI=Duke Clinical Research Institute) ARO(Academic Research Organization)ARO ARO ARO ARO DCRI DCRI DCRI CDMS=Clinical Data Management System CDISC DCRI CDISC CDMS CDMS CDMS CDMS CDMS CDMS DCRI CDMS CDMS CDISC DCRI CDMS SDTM SAS CDMS SDTM SDTM CDMS SDTM 60-70% SDTM 11

13 DCRI CDMS CDISC CDISC CDMS CDMS CDISC CDMS CDMS CDSIC CDISC SAS CDISC SDTM SDTM SAS CRO SDTM SAS SAS CDISC CDISC SAS CDMS CDISC SAS CDMS CDMS SDTM SDTM CDMS CDMS SDTM SDTM CDMS SDTM SDTM SDTM SDTM CDMS CDISC 12

14 CRO QUINTILES CDISC QUINTILESDurham, North Carolina Gary G Walker Elizabeth C. Gilmour Sherry Green Lee M. Hubbell Monica C. Mattson Michelle Pleshe Cindy Woloszyn Associate Regulatory Director, Regulatory Operations Regulatory and Technological Services Senior Director, Account Management Director, Statistical Programming Senior Analyst Director, Client Development Director, Data Management PK/PD Sr. Technical Advisor, Global Data Standards, Global Data Management Executive Director, Global Data Management I IV NDA/ 13

15 CRA CDISC 100 CDISC CDISC 14

16 Quintiles CDISC CDISC QUINTILES CDISC CDISC CRO Quintiles CRO 6080 Quintiles CDISC LAB CDISC LAB CDISC LAB CDISC LAB CDISC SDTM CDISC CDISC Quintiles CDISC CDISC CDISC CDISC 15

Quintiles CDISC experience As of February 2006 Three clients with regular (monthly) LAB data transfers More than 141 studies where the data was managed to the CDISC SDTM standard at some phase in

17 Quintiles CDISC experience As of February 2006 Three clients with regular (monthly) LAB data transfers More than 141 studies where the data was managed to the CDISC SDTM standard at some phase in data management and/or submission processing (CDM and/or biostatistics) Version 2 24 studies Version studies Version studies Phase I 61 studies Phase I/II 4 studies Phase II - 20 studies Phase III - 11 studies One NDA - 2 studies real experience working with CDISC data since 2001 These numbers represent Data Management contracts, Biostatistics contracts or contracts which combined both Data Management and Biostatistics. Quintiles CDISC QUINTILES 16

18 Percent Agree International 1. Decreased personnel time s pent on data tr ansfers (82% ) 2. Facilitated data exchange among partnering companies (80% ) 3. Facilitated regulatory reviews of submissions (75% ) 4. Decreased cost of data transfer (75% ) 5. More efficient eclinical Trial processes overall (73% ) N. America 1. Facilitate d data e xchange among partnering companies (75% ) 2. Decreased personnel time s pent on data tr ansfers (74% ) 3. Decreased cost of data transfer (71% ) 4. Improved data quality earlier in the pr ocess (67% ) 5. More rapid agreement on standar ds within a c ompany (65% ) 17

19 B SAS SAS Institute Inc. SAS CDISC SAS Campus SAS Campus Drive Cary, NC Edward D. Helton, Ph.D. Chief Pharmaceutical and Regulatory Scientist Industry Marketing Worldwide Marketing Strategy Jason Burke Sr. National Life Sciences Industry Strategist U.S. Commercial Health & Life Sciences Strategy, Alliance, and solutions David Handelsman Lead Strategist / Solution Manager, Clinical R&D Health and Life Sciences Strategy Worldwide Marketing T. Friebel SXLE Architect, XMLMAP Inventor BASE SAS R&D SAS SAS 18

20 FDA SAS xpt )FDA SAS JMP SAS SAS CDISC HL7 CDISC CDISC SAS 2006 CDSIC ODM define.xml ( define.pdf )STDM ODM CDISC CDISC SDTM/ODM SDTM & Analysis Data (content) (Content) Source data (other than SDTM/CRF data) ODM XML CRF (SDTM ODM XML CRF ODM XML + define.xml SDTM Administrative Tracking Lab Acquisition info CDISC Model SDTM ADaM re-mapping 19

21 HL7 Version3 XML CDISC Electronic Health Records(EHR) Hospital Information system CDISC Biomedical Research Information Domain Group HL SAS SAS BASE SAS ODM XML XML XML LIBNAME Engine SAS 1 define.xml ODM XML Engine SAS Programmer SAS Programmer SAS SDD() CDISC SAS 1.SAS XML LIBNAME Engine User s Guide 20

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untitled 1 CDISC CDISC standard CDISC Clinical Data Interchange Standards Consortium 1990 standard CDISC standards FDA specification FDA FDA CDISC FDA (the operational use of data) CDISC CDISC CDISC CDISC standard