Electronic Health Records for Clinical Research. EHR Compliant to Clinical Trial Requirements. Oct Disclaimer

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1 Electronic Health Records for Clinical EHR Compliant to Clinical Trial Requirements Mathias Poensgen EHRCR project / Aris Global Oct Disclaimer The views and opinions expressed in the following PowerPoint slides are those of the individual presenter and should not be attributed to Drug Information Association, Inc. ( DIA ), its directors, officers, employees, volunteers, members, chapters, councils, Special Interest Area Communities or affiliates, or any organization with which the presenter is employed or affiliated. These PowerPoint slides are the intellectual property of the individual presenter and are protected under the copyright laws of the United Statest of America and other countries. ti Used by permission. All rights reserved. Drug Information Association, DIA and DIA logo are registered trademarks or trademarks of Drug Information Association Inc. All other trademarks are the property of their respective owners

2 Overview 1. Why EHRCR To understand the rationale, objectives, status 2. Approach 3. Status 4. Summary 3 3 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 validation of 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 4 4 2

3 ehealth World Other data Local Labs Multiple stages of EHR Components & integration Coding EHR Data: Varying degrees of unstructured or non-digital information Possibly disparate systems for: Pt Visit Records Pharmacy Labs OR, etc. Various levels of standards, computer system validation and systems integration depending on country, region, institution. Entry of Patient s Clinical Data Physician / Investigator Driven by the Need to Enhance patient safety Improve quality of healthcare Reduce healthcare costs 5 5 eclinical World Driven by the Need to Provide reliable data to support safety and efficacy Clinical 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 Entry of Patient s Clinical Data Physician / Investigator 6 6 Sponsor Clinical System EDC SAE Systems validated & compliant to Industry & Regulatory standards & policies e.g. 21 CFR Part 11, CSUCI & ICH GCP Other data Coding Central Labs 3

4 Multiple stages of EHR Components & integration 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 Entry of Patient s Clinical Data Sponsor Clinical System Physician / Investigator 7 7 A Different Future We Need a common understanding and approach We Need to connect Healthcare and 8 8 4

5 A Different Future Imagine Patient Data Exchange Between Healthcare and Clinical Trial Systems Emerging and Future EHR- Connectivity and Complexity Current Divided Healthcare System Integrated Future Interoperable Ideal Clinical Trial System 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 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 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. 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 9 9 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 systems and healthcare systems sit on the same spine Systems conform to the same data exchange standards A Different Future The Benefits Patient New therapies available faster Higher quality data provides greater safety 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 Authorities Higher quality, reliable data from validated sources under investigator control Lower cost and faster Real-time identification of safety issues and approval of new prediction of trends therapies Mining of data 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 5

6 Making It Happen Bridging the Gap Needs Technical, Political & Cultural Solutions 1. Technical 2. Political/Legal 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 Standards Common data standards allow movement of data between healthcare and research HL7 Functional Model Future Connected Healthcare & Process Controlled process for release and transfer of data meets bioethical requirements EHRCR Systems Reliable, validated systems meet healthcare and research requirements EuroRec Repository Making It Happen EHRCR Electronic Health Records for Clinical Launched by ecf December 2006 at the invitation of HL7 and EuroRec to address the SYSTEM challenge for CORE Standards Common data standards allow movement of data between healthcare and research Future Connected Healthcare & Process Controlled process for release and transfer of data meets bio-ethical requirements Systems Reliable, validated systems meet healthcare and research requirements Emerging and Future EHR- Connectivity and Complexity Current Divided Healthcare System Clinical Trial System Integrated Future Interoperable Ideal 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 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

7 Rationale 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 Stakeholder Participation Pharma, EHR, Healthcare, eclinical services, regulators, associations Co-ordinatingordinating 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 7

8 Approach Global CR User Requirements International Regs al (ICH GCP, CSUCI, Part 11, Data protection ) HL7 Functional Model User Requirement System and Data Security Requirements Essential (Now) Optional (future) Conformance Criteria HL7 Shall have Should have May have System shall have an audit trail to include recording date/time/author of any data creation, change, or deletion and reason Relevance Tier 1 (Core) Regulatory Link CSUCI: D2b, D2c, D2f, D2g Part 11: e ICH GCP: 4.9.3, CFR: Mapped to Existing Criteria New Criteria Needed to Meet CR Needs Clinical Profiles Conformance Criteria EuroRec GS The audit log contains create/edit/ deleted events. GS Audit log records include date and time of recordable events. EuroRec Repository of Criteria Approach By mapping HL7 and EuroRec criteria to a common set of Clinical requirements we end up with a globally consistent profile expressed in the local language Clinical Requirement Regulatory Source HL7 Language EuroRec Language

9 Status 1. Clinical requirements mapped to regulations (Nov 07) 2. Assessment against Cerner s Millennium system (Jun 08) Met must have criteria % (outright 79.4%, via process and/or acceptable risk 20.3%) 3. Profile of HL7 criteria passed HL7 ballot (Jan 09) 4. Profile of EuroRec criteria submitted to EuroRec (Apr 09) 5. Practical guide for sites on implementation (Jun 09) 6. Profile of HL7 criteria accepted as ANSI standard (Jul 09) 7. Added to CCHIT roadmap for Next Steps Mock Assessments EuroRec EuroRec Repository Repository EHRCR EHRCR Profiles Profiles CEN Standard EHRCR FP??? EU Certification of EHRs for Clinical??? EHRCR User Requirements Practical guide for sites Implementation support HL7 EHRCR Profile ANSI Standard EHRCR Profile CCHIT Certification of EHRs for Clinical Mock Assessments

10 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 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

11 For more information