Electronic Health Records for Electronic Health Records for Clinical Research Clinical Research

The EHRCR Functional ProfileThe EHRCR Functional Profile

EuroRec Conference 2009EuroRec Conference 2009

Richard PerkinsRichard PerkinsPresident, eClinical ForumPresident, eClinical Forum

Overview…Overview…

1. Background

2. A Different Future

3. Challenges

4. Making It Happen

5. Summary

To understand To understand the issue, the issue,

opportunity opportunity and status…and status…

To understand To understand the issue, the issue,

opportunity opportunity and status…and status…

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About the eClinical Forum…About the eClinical Forum…

• A not-for-profitnot-for-profit and non-commercial association non-commercial association

• 55 companies 55 companies from Pharma R&D, service industries (eClinical system

vendors, CROs, consultancies etc), academia, EHR.

• European & North AmericanEuropean & North American

• Activities cover electronic data acquisition, processing and data acquisition, processing and useuse for clinical research

• Share experiences, develop public domain public domain deliverables and to shape the future of the clinical research environment

Contributes Extensively To Information In The Public Domain

SurveysSurveys … Industry status and trends, performance metrics, investigator attitudes, auditing experiences, system capabilities

ReportsReports … Business value of EDC; eSource, Connecting Healthcare & Research

ToolsTools … RFI development; Technology scale up

KnowledgeKnowledge … eHealth terminology; Mobile data collection

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The eSource Issue…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 no paper records records are used.

requirements that must be met … – documentation of the validationvalidation 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 complete copies of records copies of records suitable for inspection, review, and copying by the agency;

– documentation of a secure, computer-generated, time-stamped audit trail audit trail …

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Growth of EHRs…Growth of EHRs…

EU Hospital EHR (2004)EU Hospital EHR (2004)

50%

EU GPs (2008)EU GPs (2008)

67-92%

12%

US Adoption US Adoption of EHR (2005)of EHR (2005)

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eHealth World…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

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eClinical Research World…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

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

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Driven by the Need to…– Provide reliable data to

support safety and efficacy

The Problem…The Problem…

Multiple stages of EHR Components & integration Sponsor Clinical

Research System

Entry of Patient’s Clinical Data

Data entry is duplicated Data entry is duplicated causing additional effort for causing additional effort for

physicians physicians

Source data held in EHR Source data held in EHR may not be appropriate as may not be appropriate as

source for regulated clinical source for regulated clinical studies studies

Physician / Investigator

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A DifferentA Different Future…Future…

We Need… We Need… a common a common understanding understanding and approach and approach

We Need… We Need… to to connect connect Healthcare and Healthcare and ResearchResearch

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A DifferentA Different Future…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 IdealCurrent Divided

Emerging and Future EHR-Research Connectivity and ComplexityEmerging and Future EHR-Research Connectivity and Complexity

Clinical TrialSystem

Healthcare System

Imagine… Patient Data Exchange Between Healthcare Imagine… Patient Data Exchange Between Healthcare and Clinical Trial Systemsand Clinical Trial Systems

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A DifferentA Different Future…The Benefits…Future…The Benefits…

PatientPatientNew therapies available fasterHigher quality data provides

greater safetyReal-time identification of Real-time identification of

safety issues and prediction safety issues and prediction of trendsof trends

HealthcareHealthcareIdentification of target populationReduced effort for data provision leaves more time for patient Reduced effort for data provision leaves more time for patient

carecareSimplified safety reporting and managementPotential to conduct more researchFamiliarity of one interfaceFamiliarity of one interface

ResearchResearchPreflight of trial criteria improves trial successAccess to healthcare data to improved patient recruitmentEarly identification of safety issues and trial termination improves patient

safetyEconomies allow research in niche/neglected areas of high medical needsGreater EU investment in research and talent

AuthoritiesAuthoritiesHigher quality, reliable data Higher quality, reliable data

from validated sources under from validated sources under investigator controlinvestigator control

Lower cost and faster approval of new therapies

Mining of data

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1. Technical

2. Political/LegalRemove legal obstacles

Link stakeholders

Drive need for change

3. CulturalWork with stakeholders and partners to

change perceptions and build consensus

Build the business case for change

Making It Happen…Making It Happen…

Bridging the Gap Needs Technical, Political Bridging the Gap Needs Technical, Political & Cultural Solutions& Cultural Solutions

ProcessControlled process

for release and transfer of data

meets bio-ethical requirements

Future Connected

Healthcare & Research

StandardsCommon data standards allow

movement of data between

healthcare and research

SystemsReliable, validated

systems meet healthcare and

research requirements

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EHRCREHRCREHRCREHRCR

Making It Happen…EHRCRMaking It Happen…EHRCR

Electronic Health Records for Clinical Research Electronic Health Records for Clinical Research Launched by eCF December 2006 at the invitation of HL7 and

EuroRec to address the SYSTEM challenge for COREto address the SYSTEM challenge for CORE

ProcessControlled process for release and transfer of data meets bio-

ethical requirements

Future Connected Healthcare

& Research

StandardsCommon data standards allow

movement of data between

healthcare and research

SystemsReliable, validated

systems meet healthcare and

research requirements

SystemsReliable, validated

systems meet healthcare and

research requirements

www.ehrcr.org

Integrated Future Interoperable Ideal

Current Divided

Emerging and Future EHR-Research Connectivity and ComplexityEmerging and Future EHR-Research Connectivity and Complexity

Clinical TrialSystem

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 Proposing profiles of criteria for what determines a ‘reliable’ data source‘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 Proposing profiles of criteria for what determines a ‘reliable’ data source‘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

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Rationale…Rationale…

It is an important project to:– Remove risk of clinical trial data rejection

because of unreliable source data unreliable source data (e.g. FDA warning letter 2006)

– Provide EHR system developers with the business case and the clinical research clinical research functionality to be incorporated functionality to be incorporated into their systems

– Help healthcare system implementers understand the operational functionality operational functionality required required for regulated clinical research

– Provide sponsors and certification bodies with the basis for evaluating EHR systems evaluating EHR systems as source data repositories

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Stakeholder Participation…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, Pharma, EHR, Healthcare, eClinical services, regulators, associationsregulators, associations

Global Participants:

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Approach…Approach…

Global CR User Requirements…User RequirementUser Requirement Tier 1 (Core)Tier 1 (Core)

RelevanceRelevance Regulatory LinkRegulatory 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 RegsInternational Regs

International Regs (ICH GCP, CSUCI, Part 11, Data protection…)

International Regs (ICH GCP, CSUCI, Part 11, Data protection…)

Conformance Conformance CriteriaCriteria

HL7HL7

Shall have……

Should have…

May have…

Conformance Conformance CriteriaCriteria

EuroRecEuroRecGS002183.02 The audit log contains create/edit/ deleted events.

GS002188.01 Audit log records include date and time of recordable events.

HL7 Functional Model

HL7 Functional Model

…Mapped to Existing Criteria

…New Criteria Needed to Meet

CR Needs…

EuroRec Repository of Criteria

EuroRec Repository of Criteria

…Clinical Research Profiles

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Approach…Approach…

By mapping HL7 and EuroRec criteria to a common set of Clinical By mapping HL7 and EuroRec criteria to a common set of Clinical Research requirements we end up with a globally consistent profile Research requirements we end up with a globally consistent profile expressed in the ’local language’expressed in the ’local language’

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Status…Status…

1.1. Clinical Research requirements Clinical Research requirements mapped to regulations (Nov 07)

2.2. Mock Assessment Mock Assessment against Cerner’s Millennium system (Jun 08)Met must have criteria - 99.7% (outright 79.4%, via process and/or acceptable risk at 20.3%)

3. Profile of HL7 criteria passed HL7 normative ballot passed HL7 normative ballot (Jan 09)

4. Profile of EuroRec criteria submitted to EuroRec submitted to EuroRec (Apr 09)

5.5. Practical guidePractical guide for sites on implementation (Jun 09)

6. Submitted and accepted as ANSI standard ANSI standard (Jul 09)

7.7. On the CCHIT roadmap for 2010On the CCHIT roadmap for 201018

Next Steps…Next Steps…

Clinical Research

Regulations & Guidances

EHRCR User Requirements

EuroRec Repository

EHRCR Profile

HL7

EHRCR Functional

Profile

EU Certification of

EHRs for Clinical

Research???

ANSI Standard EHRCR FP

CCHIT Certification of

EHRs for Clinical

Research

CEN Standard EHRCR FP ???

Practical guide for sites

Mock Assessments

Implementation support

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A Recap…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 research systems must already meet the minimum requirements.

– ‘Connected‘ systems will require new criteria for research and healthcare systems

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A Recap…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 growthOrganic growth

– Pharma evaluation with shared results

– Self certification

– Formal Certification (e.g. via EuroRec / Notifying Bodies / National)

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For more information …For more information …

www.ehrcr.org richard.perkins@con7.com

www.ehrcr.org richard.perkins@con7.com