1. Clinical Research Information System (EHR/CR) – Functional Profile HL7 Working Group EHR-S Technical Committee Presentation

2. Agenda EHR/CR-FP Working Group EHR/CR-FP Working Group Team Members Team Members eHealth (EHR) eHealth (EHR) Business Realities of Drug Development Business Realities of Drug Development The Challenge The Challenge The Profile The Profile

3. EHR/CR-FP Working Group Organized by the eClinical Forum and PhRMA EDC/eSource Task Force. Organized by the eClinical Forum and PhRMA EDC/eSource Task Force. International Representation International Representation Collaborative effort between bio- pharmaceutical and healthcare industries and associated vendors Collaborative effort between bio- pharmaceutical and healthcare industries and associated vendors

4. EHR/CR-FP Co-chairs John D. MestlerProcter & Gamble Pharmaceuticals Suzanne BishopSKB Consulting EHR/CR-FP Functional Profile Working Group (International Group) Seema Bhat Bayer Paul BrandonSiemens Medical Solutions Robert CaseProcter & Gamble Pharmaceuticals Catherine Celingant Millennium Pharmaceuticals Gary DruckerBayer Patricia GregoryBoehringer Ingelheim Jane GriffinCerner Corporation Ian HamiltonEli Lilly Darlene KalinowskiBristol Myers Squib Linda KingEli Lilly Marie MacDonaldClinPhone Richard PerkinsConcept Consulting Mathias PoensgenAltana Pharmaceuticals Christian ReichMillennium Pharmaceuticals Vincente RodriguezEli Lilly Miguel ValenzuelaRoche

5. eHealth is Driven by the need to… Bringing information and knowledge to the point of care Realizing this across boundaries Moving from specialist-centric to patient- centric information Enhance patient safety Improve quality of healthcare Reduce healthcare costs eHealth is About…

6. Business Realities of Drug Development The Facts Innovation of medicines is a high-risk business Innovation of medicines is a high-risk business Less than 9% of clinical candidates make it to patients The cost and timescale of innovative medicine has escalated The cost and timescale of innovative medicine has escalated A new molecule can cost $750M -$1.0B and takes 11-15 years to develop Research $ focused where there is a ROI Research $ focused where there is a ROI The Results Failure to innovate is leading to fewer new innovative medicines reaching the patient Failure to innovate is leading to fewer new innovative medicines reaching the patient Failure to control cost and move fast enough is leading to more expensive and late therapies Failure to control cost and move fast enough is leading to more expensive and late therapies Potential medicines not reaching the patient and niche markets of high medical need not being explored Potential medicines not reaching the patient and niche markets of high medical need not being explored

7. Electronic Data Capture (EDC) Reporting DATA ATADATA ATADATA CDMS Site EDC Web Server Subject Paper ePRO Web Server Labs Archive & Submission ECG Source ePRO

8. The Challenge … Patient visit Paper Medical Record Paper or Electronic Medical Record Paper CRF EHR-S Trial Future Integration Approaches To Clinical Trial Data Capture At Investigator Sites Research Database Electronic CRF, ePRO, Labs Research Database Emerging but Duplicative Historical Hosted Data HealthcareResearch EDC Trial Specific Data Electronic Health Record With the increased use of EHR / EMR, the Emerging EDC Environment Results In… increased effort, cost, possibility of questionable authenticity

9. The Challenges … Results In… Minimized effort and cost, better data quality, improved drug safety, greater research opportunity Process Controlled process for release and transfer of data meets bio-ethical concerns Future Connected Healthcare & Research Standards Common data standards allow movement of data between healthcare and research Systems Reliable, validated systems meet healthcare and research requirements

10. EHR/CR Profile Description Establishes requirements, non-redundant functions, processes to use patient electronic medical data for clinical research. Establishes requirements, non-redundant functions, processes to use patient electronic medical data for clinical research. Ensures that data protection, regulatory, and ethical research requirements are met. Ensures that data protection, regulatory, and ethical research requirements are met. Minimizes the challenges of clinical research for healthcare professionals. Minimizes the challenges of clinical research for healthcare professionals. Endorses data standards (CDISC/HL7) for data collection, interpretation and exchange within the medical and research communities. Endorses data standards (CDISC/HL7) for data collection, interpretation and exchange within the medical and research communities. Expand and adapt functions of EHR and the associated systems, networks, and processes Expand and adapt functions of EHR and the associated systems, networks, and processes

11. Profile Objective Develop an HL7 Informative Functional Profile that identifies critical capabilities for clinical research utilizing EHR systems. Develop an HL7 Informative Functional Profile that identifies critical capabilities for clinical research utilizing EHR systems. Establish conformance to the HL7 EHR Functional Model, under the auspices and direction of the EHR Technical Committee. Establish conformance to the HL7 EHR Functional Model, under the auspices and direction of the EHR Technical Committee. Provide EHR vendors conformance criteria that are specific to Clinical Research. Provide EHR vendors conformance criteria that are specific to Clinical Research. Encourage incorporation of the functions necessary to utilize the Electronic Health Records as the direct data source for clinical studies. Encourage incorporation of the functions necessary to utilize the Electronic Health Records as the direct data source for clinical studies. Define additional functions that may be required and have not yet been included within existing functional models. Define additional functions that may be required and have not yet been included within existing functional models. International Profile International Profile

12. Profile Phases The project is planned in four phases: The project is planned in four phases: Organization Organization participants, determination ofparticipants, determination of scopescope care settingcare setting Project PlanProject Plan Formalization –EHR/CR-FP functions and conformance criteria (in process). Formalization –EHR/CR-FP functions and conformance criteria (in process). Harmonization – comparison, incorporation, and alignment with the EHR FM (in process). Harmonization – comparison, incorporation, and alignment with the EHR FM (in process). Finalization – Conformance and preparation for final EHR – TC approval and external publication. Finalization – Conformance and preparation for final EHR – TC approval and external publication.

13. Profile – Essential Now (EN) Ensure that patient data from an EHR system will meet clinical research regulatory requirements for data collection, management, extraction, security, and can be interpreted in a consistent manner. Ensure that patient data from an EHR system will meet clinical research regulatory requirements for data collection, management, extraction, security, and can be interpreted in a consistent manner. Functions must be present to use EHR data for clinical research without redundant re-keying and verifying Functions must be present to use EHR data for clinical research without redundant re-keying and verifying Note: If we can think of a reasonable work-around we can move function into the essential future

14. Profile – Essential Future Functions needed to improve efficiency and performance Functions needed to improve efficiency and performance Functions necessary to ultimately conduct all clinical research data capture and management through nation-wide health information networks and systems. Functions necessary to ultimately conduct all clinical research data capture and management through nation-wide health information networks and systems. Functions will be divided into levels along the evolution to this ultimate goal. None of the EF functions will be required to be present on day 1 of using the EHR data for clinical research. (Sponsors can provide work-arounds either through processes or sponsor-supplied electronic systems). Functions will be divided into levels along the evolution to this ultimate goal. None of the EF functions will be required to be present on day 1 of using the EHR data for clinical research. (Sponsors can provide work-arounds either through processes or sponsor-supplied electronic systems).

15. Profile – Essential Future Examples of Possible Future Functions The function should support data checking (i.e., for reasonableness as defined by the trial sponsor) The function should support data checking (i.e., for reasonableness as defined by the trial sponsor) Electronic signature capability in compliance with Part 11 Electronic signature capability in compliance with Part 11