Electronic Health Records for
Clinical Research
EHR Compliant to Clinical Trial
Requirements
EuroRec Conference 2009
Richard Perkins
President, eClinical Forum
Overview…
1. About the eCF
To understand
the rationale,
objectives,
status…
2. Why EHRCR
3. Approach
4. Status
5. Summary
2
About the eClinical Forum…
• Not-for-profit and 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
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
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
Growth of EHRs…
EU Hospital EHR (2004)
EU GPs (2008)
50%
67-92%
12%
(now
20-25%)
US Adoption
of EHR (2005)
5
eHealth World…
Multiple stages of EHR
Components & integration
Driven by the
Need to…
Possibly disparate
systems for:
•Pt Visit Records
Other data
•Pharmacy
Coding
•Labs
•OR, etc.
Local
Labs
EHR Data:
Varying
degrees of
unstructured
or non-digital
information
Various levels of standards,
computer system validation and
systems integration depending
on country, region, institution.
Entry of
Patient’s
Clinical
Data
– Enhance patient
safety
– Improve quality
of healthcare
– Reduce
healthcare costs
Physician /
Investigator
6
eClinical Research World…
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
Entry of
at the site
Patient’s
Systems used for
clinical research
have to fulfill
strong regulatory
requirements
Coding
Clinical
Data
SAE
EDC
Physician /
Investigator
Systems validated & compliant
to Industry & Regulatory
standards & policies e.g. 21
CFR Part 11, CSUCI & ICH
GCP
Central
Labs
7
The Problem…
Multiple stages of EHR
Components & integration
Source data held in EHR
may not be appropriate as
source for regulated clinical
studies
Sponsor Clinical
Research System
Data entry is duplicated
causing additional effort for
physicians
Entry of
Patient’s
Clinical
Data
Physician /
Investigator
8
A Different Future…
We Need…
a common
understanding
and approach
We Need…
to connect
Healthcare and
Research
9
A Different Future…
Imagine… Patient Data Exchange Between Healthcare
and Clinical Trial Systems
Emerging and Future EHR-Research Connectivity and Complexity
Integrated Future
Current Divided
Interoperable
Ideal
Healthcare System
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
• 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
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
• 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
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A Different Future…The Benefits…
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
Patient
Higher quality, reliable
data from validated
sources under
investigator control
New therapies available faster
Higher quality data provides
greater safety
Real-time identification of
safety issues and
prediction of trends
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
11
Making It Happen…
Bridging the Gap Needs Technical, Political
& Cultural Solutions
EHRCR
1. Technical
2. Political/Legal
Remove legal obstacles
Link stakeholders
Drive need for change
HL7 Functional
Model
Standards
EuroRec
Repository
Systems
Common data
Reliable,
standards allow
validated
movement of
systems meet
Future
data between
Connected healthcare and
healthcare and
Healthcare &
research
research
Research
requirements
3. Cultural
Work with stakeholders and
partners to change perceptions
and build consensus
Build the business case for change
Process
Controlled process for
release and transfer
of data meets bioethical requirements
12
Making It Happen…EHRCR
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
Emerging and Future EHR-Research Connectivity and Complexity
Systems
Standards
Reliable,
Common data
validated
standards allow
systems meet
movement of
healthcare and
data between
Future
healthcare and
research
Connected requirements
research
Integrated Future
Interoperable Ideal
Current Divided
Healthcare
System
Clinical Trial
System
Healthcare
& Research
Process
Controlled process for
release and transfer of
data meets bio-ethical
requirements
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
13
www.ehrcr.org
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
14
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
15
Approach…
Global CR User Requirements…
User Requirement
International
International
Regs
Regs
(ICH GCP, CSUCI,
Part 11, Data
protection…)
Tier 1 (Core)
Relevance
System and
Data Security
Requirements
System shall have an
audit trail to include
recording
date/time/author of any
data creation, change,
or deletion
Essential (Now)
Optional (future)
… and reason …

Regulatory Link
CSUCI: D2b, D2c,
D2f, D2g
Part 11: 11.10 e
ICH GCP: 4.9.3,
5.5.4
21 CFR: 312.62

…Mapped to Existing Criteria
HL7
Functional
Model
Conformance
Criteria
Conformance
Criteria
HL7
Shall have……
Should have…
May have…
…New Criteria
Needed to Meet
CR Needs…
…Clinical
Research
Profiles
EuroRec
Repository
of Criteria
EuroRec
GS002183.02 The audit log
contains create/edit/ deleted
events.
GS002188.01 Audit log
records include date and time
of recordable events.
16
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’
17
Status…
1. Clinical Research requirements mapped to
regulations (Nov 07)
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%)
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 2010
18
Next Steps…
Mock
Assessments
EuroRec
EuroRec
Repository
Repository
EHRCR
EHRCR
Profiles
Profiles
EHRCR User
Requirements
CEN Standard
EHRCR FP ???
Practical guide
for sites
Implementation
support
HL7
ANSI Standard
EHRCR Profile
EHRCR Profile
EU Certification of
EHRs for Clinical
Research???
CCHIT
Certification of
EHRs for Clinical
Research
Mock
Assessments
19
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
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…
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For more information …
www.ehrcr.org
richard.perkins@con7.com
22