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Health Information Technology Summit eHealth Initiative Washington October 22, 2004

Health Information Technology Summit eHealth Initiative Washington October 22, 2004. The Transformation of Clinical Research Integration of Policy and Process with Information Technology. Charles Jaffe, MD, PhD Director Medical Informatics, AstraZeneca.

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Health Information Technology Summit eHealth Initiative Washington October 22, 2004

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  1. Health Information TechnologySummiteHealth InitiativeWashington October 22, 2004 The Transformation of Clinical Research Integration of Policy and Process with Information Technology Charles Jaffe, MD, PhD Director Medical Informatics, AstraZeneca

  2. Transformation of Clinical ResearchThe Landscape An Overview • The US Healthcare System • The Global Pharma & Biotech world • Clinical Research today • The state of Pharma IT • Bird’s eye view of the NHII • Beyond CDISC • Single Source • Phoenix rising • Making Integration pay off

  3. Transformation of Clinical ResearchThe Landscape “There are two kinds of people. Those who finish what they start and so on.” -Robert Byrne

  4. Transformation of Clinical ResearchHealthcare Perspective The US Healthcare System • Accelerating portion of the GNP • Disproportionate error rates in patient care • Inequitable rewards for productivity not quality • Failed experiments in payer system models • Escalating costs driven by technology and innovation • Unfavorable demographics with an aging population • Challenging social consequences of un-insured and under-insured • Delay in the transfer of research findings into clinical practice

  5. Clinical Research Information InfrastructurePharmaceutical Perspective The Global Pharma Dilemma • Increasing cost of drug development • Disproportionate decline in new molecules brought to market • Escalating primary data sources and formats (genomics data) • Insufficient and under-utilized data standards • Incompatible data standards • Competing Regulatory requirements • Abbreviated life cycle for new compounds • Challenging pricing models not based on value • Delay in the transfer of best practices and inadequate knowledge management

  6. Clinical Research Information Infrastructure Pharmaceutical Perspective The Pharma IT Conundrum • “Pharma is in the Information business” • World wide R&D Spend $50B /year • IT investment: 8% ($4B /year) • IT funds devoted to support, maintenance, connectivity: 90% • IT funds devoted to innovation: 10% • Which comes to $400M /year • Ouch! Source: Bio-IT World 2003 Survey of Research IT Executives

  7. Clinical Research Information Infrastructure Pharmaceutical Perspective The Pharma/Biotech IT Spend • “IT is the number one factor for success.” • How do you rate success factors for R&D? • Number 1: Quality of IT (81%) • Number 2: Quality of scientists (27%) • Predicted growth for IT spending • 2003: 27% • 2013: 42% • Realized growth for IT spending • 2003: 0% * Your actual milage may vary. Source: BioIT World 2003 Survey of Research IT Executives

  8. National Health Information Infrastructure National Perspective Implementation of NHII • Demonstration projects • Establishment of architecture principles • Resolution of patient identification issues • Maturation of environment for scalable growth • Development of low barriers to entry • Incremental approach to adoption, with managed cost and risk • Development of processes to align incentives for all stakeholders

  9. National Health Information Infrastructure Pharmaceutical Perspective Integration with NHII: Next Steps • Formation of action committees within individual pharmaceutical and biotech companies • Meeting in Bio-Pharma stakeholders, with NHII leadership • Coordination with global counterparts to investigate harmonization activities • Interaction with academic and government (NIH) research entities to explore opportunities

  10. National Health Information Infrastructure Bio-Pharma Perspective Implementation of NHII by Bio-Pharma • Clinical Research Stakeholders group • Bio-Pharma special interest group • HL7 Outreach Committee on Clinical Research (OCCR) • Secretary’s Panel on Healthcare IT • Integration with IT standards

  11. International Conference on Harmonization (ICH) Clinical Data Interoperability 2004 EFPIA JPMA PhRMA EMEA MHLW KIKO U.S. FDA CDISC ADaM SDS ODM LAB MedDRA eCTD = Dictionary, Codelist = Document Standard, or Architecture = Organization = Standard = Model

  12. International Conference on Harmonization (ICH) Clinical Data Interoperability 2004 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

  13. Principal Investigator’s OfficeAfter the paper is gone 6 1 5 2 3 4

  14. Integration with NHII: Subject Recruitment Design Recruitment Data Collection Analysis Decision Support EHR

  15. Integration with NHII: Data Collection Design Recruitment Data Collection Analysis Lab X-ray PE HIPAA EHR

  16. Single Source: Flow of Clinical Trial Data HL7 Messaging CDISC ODM Interchange CDISC SDS HL7 CDA EMR Database Clinical Trial eSource Document CRF Fields & Metadata FDA Submission Database eCRF Data (Document) Operational Database [Sponsor] eVerification / Audit Data Entry by Clinician Data Entry by Investigator or CRC Hospital Lab Data Central LAB Data

  17. Clinical Trial – Clinical Care Data One Corner of the World

  18. Preclinical & Clinical Data Integration HL7 Preclinical Data Repository Target Data Disease Models Biomarkers ADME PK/PT Toxicology Genomic data Proteomic data

  19. Preclinical & Clinical Data Integration Broadened Perspective

  20. Preclinical & Clinical Data Integration CDISC FDA Post-Development Data Repository Structured Product Label Manufacturing GMP Pharmaco- Vigilance

  21. Mission Phoenix Bio-Pharma GovernmentAcademicCollaboration Mission Phoenix • Collaborative project between industry, government, and academia to facilitate data interchange • Cooperative effort between the NIH and the FDA spurred by the Inter-Agency Operational Task Force • Developed with the experience of prior industry initiatives • SEBiX (Secure Electronic Biopharmaceutical Information Exchange) • SAFE (Secure Access for Everyone)

  22. Mission Phoenix Bio-Pharma GovernmentAcademicCollaboration Mission Phoenix Model eCTD Files Documents Form 1572 JANUS Functional Applications SAFE Bio-Pharma Companies Investigators

  23. National Health Information Infrastructure Pharmaceutical Perspective Integration with NHII: Risks • Regulatory barriers • Incompatibility with global initiatives • Infrastructure costs • Insufficiencies of technical skill sets • Political opposition • Consumer apprehension • Standards incompatibility • Change Management

  24. Transformation of Clinical TrialsInformation There are just two rules for success: 1. Never tell all you know. -Roger H. Lincoln For more information, please contact charles.jaffe@astrazeneca.com

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