Upload
harvey-robertson
View
219
Download
0
Tags:
Embed Size (px)
Citation preview
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…
2
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
3
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 …
4
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)
5
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
6
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
7
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
8
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
9
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
10
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
11
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
12
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
13
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
14
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:
15
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
16
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’
17
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
19
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
20
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)
21
22
For more information …For more information …
www.ehrcr.org [email protected]
www.ehrcr.org [email protected]