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Electronic Health Records for Clinical Research. EHR Compliant to Clinical Trial Requirements. EuroRec Conference 2009. Richard Perkins President , eClinical Forum. Overview…. To understand the rationale, objectives, status…. About the eCF Why EHRCR Approach Status Summary.

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Electronic Health Records for Clinical Research


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

    2. Overview… • To understand the rationale, objectives, status… About the eCF Why EHRCR Approach Status Summary

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

    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 … data obtained during study visits are entered directly into the EMR, and no paper records are used. requirements that must be met … • documentation of the validationof your EMR system to ensure accuracy, reliability, and the ability to detect invalid or altered records; • documentation of the ability to generate accurate and complete copies of records suitable for inspection, review, and copying by the agency; • documentation of a secure, computer-generated, time-stamped audit trail …

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

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

    7. eClinical Research World… Systems validated & compliant to Industry & Regulatory standards & policies e.g. 21 CFR Part 11, CSUCI & ICH GCP • Driven by the Need to… • Provide reliable data to support safety and efficacy Sponsor Clinical Research System Other data 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 Coding Entry of Patient’s Clinical Data SAE EDC Central Labs Physician / Investigator

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

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

    10. Healthcare System Clinical Trial System A DifferentFuture… Imagine… Patient Data Exchange Between Healthcare and Clinical Trial Systems Emerging and Future EHR-Research Connectivity and Complexity Interoperable Ideal Integrated Future Current Divided • 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. • 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 • IntegratedFuture • 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

    11. 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 Patient New therapies available faster Higher quality data provides greater safety Real-time identification of safety issues and prediction of trends A DifferentFuture…The Benefits… Authorities Higher quality, reliable data from validated sources under investigator control Lower cost and faster approval of new therapies Mining of data Research Pre-flight of trial criteria improves trial success Access to healthcare data to improved patient recruitment Early identification of safety issues and trial termination improves patient safety Data handling efficiencies

    12. Standards Common data standards allow movement of data between healthcare and research Systems Reliable, validated systems meet healthcare and research requirements Future Connected Healthcare & Research Process Controlled process for release and transfer of data meets bio-ethical requirements Making It Happen… Bridging the Gap Needs Technical, Political & Cultural Solutions EHRCR • Technical • Political/Legal • Remove legal obstacles • Link stakeholders • Drive need for change • Cultural • Work with stakeholders and partners to change perceptions and build consensus • Build the business case for change EuroRecRepository HL7 Functional Model

    13. Healthcare System Standards Common data standards allow movement of data between healthcare and research Clinical Trial System Future Connected Healthcare & Research Process Controlled process for release and transfer of data meets bio-ethical requirements Making It Happen…EHRCR Electronic Health Records for Clinical Research Launched by eCF December 2006 at the invitation of HL7 and EuroRecto address the SYSTEM challenge for CORE Emerging and Future EHR-Research Connectivity and Complexity Systems Reliable, validated systems meet healthcare and research requirements Interoperable Ideal Integrated Future Current Divided Core (CurrentDivided) Ensure reliability and traceability of electronic source data used for CR by… 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 of the functions necessary to utilize the Electronic Health Records as the direct data source for clinical studies www.ehrcr.org

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

    15. Stakeholder Participation… Pharma, EHR, Healthcare, eClinical services, regulators, associations Co-ordinating Partners: Technical Partners: EDC/eSource Taskforce Gold Level Partners: Global Participants: • 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

    16. Approach… Global CR User Requirements… International Regs International Regs (ICH GCP, CSUCI, Part 11, Data protection…) Essential (Now)  Optional (future) …Mapped to Existing Criteria HL7 Functional Model EuroRec Repository of Criteria …New Criteria Needed to Meet CR Needs… …Clinical Research Profiles

    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’ Clinical Research Requirement Regulatory Source HL7 ‘Language’ EuroRec ‘Language’

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

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

    20. A Recap… eSource is a growing issue and today’s solutions will not fit future needs Work by HL7 and EuroRec on EHR functional criteria have presented an opportunity to address the reliability of eSource today 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

    21. A Recap… 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) We need to define how best to manage the implementation process Organic growth… Pharma evaluation with shared results… Self or formal certification…

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