1. Electronic Health Records for Clinical Research EHR Compliant to Clinical Trial Requirements EuroRec Conference 2009 Richard Perkins President, eClinical Forum

2. Overview… 1.About the eCF 2.Why EHRCR 3.Approach 4.Status 5.Summary To understand the rationale, objectives, status… 2

3. About the eClinical Forum… Not-for-profit non-commercial associationNot-for-profit and non-commercial association 55 companies55 companies from Pharma R&D, service industries, academia, EHR Trans-AtlanticTrans-Atlantic clinical researchActivities cover electronic data acquisition, processing and use for clinical research public domainShare experiences, develop public domain deliverables and to shape the future of the clinical research environment Surveys Surveys … Industry status and trends, performance metrics, investigator attitudes, auditing experiences, system capabilities Reports Reports … Business value of EDC; eSource, Connecting Healthcare & Research Tools Tools … RFI development; Technology scale up Knowledge Knowledge … eHealth terminology; Mobile data collection 3

4. The eSource Issue… … you use an electronic medical record (EMR) system to maintain medical and other clinical data for your patients, including study subjects no paper records … data obtained during study visits are entered directly into the EMR, and no paper records are used. requirements that must be met … validation –documentation of the validation of your EMR system to ensure accuracy, reliability, and the ability to detect invalid or altered records; complete copies of records –documentation of the ability to generate accurate and complete copies of records suitable for inspection, review, and copying by the agency; audit trail –documentation of a secure, computer-generated, time-stamped audit trail … 4

5. Growth of EHRs… EU Hospital EHR (2004) 50% EU GPs (2008) 67-92% 5 12% (now 20-25%) US Adoption of EHR (2005)

6. eHealth World… Driven by the Need to… –Enhance patient safety –Improve quality of healthcare –Reduce healthcare costs Multiple stages of EHR Components & integration Entry of Patient’s Clinical Data Various levels of standards, computer system validation and systems integration depending on country, region, institution. Physician / Investigator EHR Data: Varying degrees of unstructured or non-digital information Coding Pt Visit Records Pharmacy Labs OR, etc. Possibly disparate systems for: Other data Local Labs 6

7. eClinical Research World… Sponsor Clinical Research System Systems validated & compliant to Industry & Regulatory standards & policies e.g. 21 CFR Part 11, CSUCI & ICH GCP Entry of Patient’s Clinical Data EDC Coding Physician / Investigator Other data Central Labs SAE Clinical Research has moved from capturing data on paper to electronic data capture at the site Systems used for clinical research have to fulfill strong regulatory requirements 7 Driven by the Need to… –Provide reliable data to support safety and efficacy

8. The Problem… Multiple stages of EHR Components & integration Sponsor Clinical Research System Entry of Patient’s Clinical Data Source data held in EHR may not be appropriate as source for regulated clinical studies Data entry is duplicated causing additional effort for physicians Physician / Investigator 8

9. A Different Future… We Need… a common understanding and approach We Need… to connect Healthcare and Research 9

10. A Different Future… Integrated Future Healthcare data can be used to automatically identify suitable candidates for clinical trials Clinical care data is entered once into EHR Relevant data from EHR are seamlessly transferred to clinical trial systems so that no data transcription occurs for a significant proportion of clinical trial data held as source within EHR. Research holds very little ‘source’ data and clinical trial data not collected at the site is transferred to EHR from clinical trial information systems Queries can be handled electronically. The EHR system functions as the patient data repository Interoperable Ideal EHR and research systems work seamlessly together so that groups benefit from data access and mining capabilities across healthcare and research data sets Research systems and healthcare systems sit on the same spine Systems conform to the same data exchange standards Current Divided (Core EHRCR Scenario) EHR systems holding source for data used in clinical trials may not meet essential regulatory requirements Clinical care data required for clinical trials is entered into EHR and into clinical trial systems Research holds source data not part of normal clinical care Redundant data entry, transcription errors and source issues cost healthcare and industry time and money. Integrated Future Interoperable Ideal Current Divided Emerging and Future EHR-Research Connectivity and Complexity Clinical Trial System Healthcare System Imagine… Patient Data Exchange Between Healthcare and Clinical Trial Systems 10

11. A Different Future…The Benefits… Patient New therapies available faster Higher quality data provides greater safety Real-time identification of safety issues and prediction of trends Healthcare Healthcare Identification of target population Reduced effort for data provision leaves more time for patient care Simplified safety reporting and management Potential to conduct more research Familiarity of one interface Research Research Pre-flight of trial criteria Pre-flight of trial criteria improves trial success improved patient recruitment Access to healthcare data to improved patient recruitment Early identification of safety issues and trial termination improves patient safety Data handling efficiencies Authorities Higher quality, reliable data from validated sources under investigator control Lower cost and faster approval of new therapies Mining of data 11

12. 1.Technical 2.Political/Lega l Remove legal obstacles Link stakeholders Drive need for change 3.Cultural Work with stakeholders and partners to change perceptions and build consensus Build the business case for change Making It Happen… Bridging the Gap Needs Technical, Political & Cultural Solutions Process Controlled process for release and transfer of data meets bio- ethical requirements 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 12 HL7 Functional Model EuroRec Repository EHRCREHRCR

13. Making It Happen…EHRCR Electronic Health Records for Clinical Research to address the SYSTEM challenge for CORE Electronic Health Records for Clinical Research Launched by eCF December 2006 at the invitation of HL7 and EuroRec to address the SYSTEM challenge for CORE Process Controlled process for release and transfer of data meets bio-ethical requirements 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 Systems Reliable, validated systems meet healthcare and research requirements www.ehrcr.org Integrated Future Interoperable Ideal Current Divided Emerging and Future EHR-Research Connectivity and Complexity Clinical Trial System Healthcare System Core (Current Divided) Ensure reliability and traceability of electronic source data used for CR by… Proposing profiles of criteria for what determines a ‘reliable’ data source Proposing profiles of criteria for what determines a ‘reliable’ data source when the source of patient data is electronic within the healthcare environment Defining a process to encourage incorporation Defining a process to encourage incorporation of the functions necessary to utilize the Electronic Health Records as the direct data source for clinical studies Core (Current Divided) Ensure reliability and traceability of electronic source data used for CR by… Proposing profiles of criteria for what determines a ‘reliable’ data source Proposing profiles of criteria for what determines a ‘reliable’ data source when the source of patient data is electronic within the healthcare environment Defining a process to encourage incorporation Defining a process to encourage incorporation of the functions necessary to utilize the Electronic Health Records as the direct data source for clinical studies 13

14. Rationale… It is an important project to: unreliable source data –Remove risk of clinical trial data rejection because of unreliable source data (e.g. FDA warning letter 2006) clinical research functionality to be incorporated –Provide EHR system developers with the business case and the clinical research functionality to be incorporated into their systems operational functionality required –Help healthcare system implementers understand the operational functionality required for regulated clinical research evaluating EHR systems –Provide sponsors and certification bodies with the basis for evaluating EHR systems as source data repositories future connectivity –Prepare for future connectivity 14

15. Stakeholder Participation… Gold Level Partners: Aris Global Astellas Bayer Boehringer Ingelheim Bristol Myers Squib Cerner Corporation Eli Lilly and Company FDA Glaxo SmithKline Hoffman La Roche Lundbeck Medidata Solutions Millennium NIH: National Cancer Institute Northrop Grumman Novartis Perceptive Pfizer Procter & Gamble EDC/eSource Taskforce Co-ordinating Partners: Technical Partners: Pharma, EHR, Healthcare, eClinical services, regulators, associations Global Participants: 15

16. Approach… Global CR User Requirements… User Requirement Tier 1 (Core) Relevance Regulatory Link System and Data Security Requirements System shall have an audit trail to include recording date/time/author of any data creation, change, or deletion CSUCI: D2b, D2c, D2f, D2g Part 11: 11.10 e ICH GCP: 4.9.3, 5.5.4 21 CFR: 312.62 … and reason … Essential (Now) Optional (future) International Regs International Regs (ICH GCP, CSUCI, Part 11, Data protection…) …Mapped to Existing Criteria Conformance Criteria HL7 Shall have…… Should have… May have… HL7 Functional Model …New Criteria Needed to Meet CR Needs… Conformance Criteria EuroRec GS002183.02 The audit log contains create/edit/ deleted events. GS002188.01 Audit log records include date and time of recordable events. EuroRec Repository of Criteria …Clinical Research Profiles 16

17. Approach… By mapping HL7 and EuroRec criteria to a common set of Clinical Research requirements we end up with a globally consistent profile expressed in the ’local language’ 17 Clinical Research Requirement Regulatory Source HL7 ‘Language’ EuroRec ‘Language’

18. Status… 1.Clinical Research requirements 1.Clinical Research requirements mapped to regulations (Nov 07) 2.Assessment 2.Assessment against Cerner’s Millennium system (Jun 08) Met must have criteria - 99.7% (outright 79.4%, via process and/or acceptable risk 20.3%) passed HL7 ballot 3.Profile of HL7 criteria passed HL7 ballot (Jan 09) submitted to EuroRec 4.Profile of EuroRec criteria submitted to EuroRec (Apr 09) 5.Practical guide 5.Practical guide for sites on implementation (Jun 09) ANSI standard 6.Profile of HL7 criteria accepted as ANSI standard (Jul 09) CCHIT roadmap for 2010 7.Added to CCHIT roadmap for 2010 18

19. EuroRec Repository EHRCR Profiles Next Steps… EHRCR User Requirements EuroRec Repository EHRCR Profiles HL7 EHRCR Profile EU Certification of EHRs for Clinical Research??? ANSI Standard EHRCR Profile CCHIT Certification of EHRs for Clinical Research CEN Standard EHRCR FP ??? Practical guide for sites Mock Assessments Implementation support 19 Mock Assessments

20. A Recap… 1.eSource is a growing issue and today’s solutions will not fit future needs 2.Work by HL7 and EuroRec on EHR functional criteria have presented an opportunity to address the reliability of eSource today 3.The EHRCR project is presenting proposals for profiles and a process for their implementation –Generic user requirements have been localised by mapping to HL7 or EuroRec. –Focus is on EHR system as clinical trial systems must already meet the minimum requirements. –Future “connected” systems will require new criteria for research and healthcare systems 20

21. A Recap… 4.The criteria for the vendor technology 'what's in the box' will be different to the criteria for the 'system' in its operational environment (which will include technology, process and people) 5.We need to define how best to manage the implementation process –Organic growth… –Pharma evaluation with shared results… –Self or formal certification… 21

22. 22 For more information … www.ehrcr.org richard.perkins@con7.com