Transcript eCF Template - European Institute for Health Records

Expectations of the
Pharma Industry
Regarding EHR
Systems
Richard Perkins
eClinical Forum
Tallinn
June 2010
Overview…
How EHRs are
used today and
their future
potential for
Clinical Research
17 July, 2015
1. Introduction
2. Use of EHRs in CR
– Protocol Optimisation
– Data Capture and Provision
3. A Different Future
4. Why Now
5. EHRCR
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Introduction…
Healthcare
Pharma Research
Bringing a new treatment to the
market costs >800 M Euro and
increases at ~10% a year
Clinical research uses 55-75% of R&D
budget
>10,000 EU Clinical Trials
EU GPs (2008)
67-92%
EHR Growth to >50%
– Enhance patient safety
– Improve quality of healthcare
– Reduce healthcare costs
Physician /
Investigator
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Source: Benchmarking ICT use among General Practitioners in Europe, April 2008
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Protocol Optimisation…
Use of EHR Data to…
• Evaluate patient populations
• Optimise inclusion/exclusion
criteria
• Assess feasibility of countries/sites
• Patient identification (site)
Healthcare
250,000 patients
participate in European
clinical trials a year
Recruited by 4200
investigators
17 July, 2015
Pharma Research
58% of trials do not meet
projected recruitment rates!
49% increase in trial
procedures
54% increase in trial
workload
The Challenge…
• Limited data that may not be
representative
• Difficulty to query (different formats)
• Cost and time
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Data Capture…
The Shift to EDC…
Pharma Research
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
17 July, 2015
Entry of
Patient’s Clinical
Data
Physician /
Investigator
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Data Capture…
Growth in Electronic Data Capture to 61% of ongoing
trials (from 13% in 2001!) …
Average of 61% of
trials ongoing at
respondent sites
use EDC
40%
35%
% Responders
30%
25%
37% only
use EDC
20%
15%
‒ To provide faster,
better quality and
more reliable data to
support safety and
efficacy
10%
5%
0%
0%
10%
20%
30%
40%
50%
60%
70%
80%
Percentage of EDC Trials Ongoing at Site
No EDC Trials
Source: eClinical Forum Site Survey 2009, European data
17 July, 2015
90%
100%
All EDC Trials
N=131
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Data Capture…
Healthcare
Pharma Research
Entry of
Patient’s Clinical
Data
EHR
Physician /
Investigator
7
17 July, 2015
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Data Capture…
Healthcare and Pharma-centric Use of Technology is
Creating an Source Issue for Clinical Trials
Traditional
Research information is copied
from healthcare records to pCRF.
Healthcare retain source
Current
Research information is copied to an
electronic research environment. Sometimes
with an interim paper step and hosting to
provide healthcare ‘source’.
Paper
Medical
Record
Electronic
Medical
Record
Paper CRF
17 July, 2015
The Current
Environment Results
In…
eCRF
Source Data
Paper CRF
Source Data
Redundant data entry,
inefficiency, reliability
issues…
Trial Data
and Hosting
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Data Capture…
The eSource issue needs to be resolved
• 13% of data for the EDC
trial was first entered
into the eCRF
70%
60%
and is therefore ‘source’
within the EDC system
50%
But…
• 11% of data was entered
into a pCRF
40%
probably created to record
source trial data not part of
the patient’s site record
10%
17 July, 2015
62%
30%
13%
20%
11%
13%
1%
0%
Paper-based Electronic Paper CRF Electronic
Patient File Patient File
CRF
or Notes
or Notes
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Other
9
Data Capture…
and… The
percentage of patient data perceived as
entered into EDC system and the patient record?
70%
A significant
opportunity for
efficiency gains!
% Responders
70-100%!
In your opinion what percentage of data that was
entered into the CRF was also entered into the patient
file or notes?
60%
50%
40%
30%
20%
10%
0%
0
10
20
30
40
50
60
70
Percentage Duplicated
80
90
100
n = 124
Source: eClinical Forum Site Survey 2009, European data
17 July, 2015
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Data Capture…
Healthcare
Pharma Research
Source data held in EHR may not be appropriate
as source for regulated clinical studies …
Entry of
Patient’s Clinical
Data
EHR
Various standards, levels of system
validation and integration, data
structure depending on country,
region, institution.
11
17 July, 2015
Physician /
Investigator
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Systems validated &
compliant to Industry &
Regulatory standards &
policies e.g. CSUCI, ICH GCP
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Data Capture…
Data Errors…
Healthcare
Completing ~1400 data
points per patient
A typical trial has 6000
data queries (time and
cost to correct)
Pharma Research
Cost of handling data
queries - €60 million
17 July, 2015
• Many healthcare professionals
and researchers wonder why
the different electronic sources
can’t be linked
• This would avoid…
–Reduce redundant data entry
–Avoid data transcription errors
–Clarify the ‘source issue
–Use a familiar system
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A Different Future…
Imagine… Patient Data Exchange Between Healthcare and
Drug Development Systems
Emerging and Future EHR-Research Connectivity and Complexity
Healthcare System
Clinical Trial
System
Integrated Future
Current Divided
Interoperable Ideal
Integrated Future
Current Divided
• 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.
17 July, 2015
•EHRs used to…
•Evaluate Patient Populations
•Accelerate Patient Recruitment
•Capture CT Data
•Exchange CT Data
•The EHR becomes the patient data repository
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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
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A Different Future…
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
New innovative therapies
available earlier
Higher quality data provides greater
safety
Real-time identification of
safety issues and trends
PharmaResearch
Patient
Healthcare
Benefiting all stakeholders…
17 July, 2015
Higher quality, reliable data
from validated sources under
investigator control
Lower cost and faster approval of new
therapies
Mining of data
Evaluation of trial criteria for concept development
and trial feasibility improves trial success
Linking of patients to trials to improve patient
recruitment
Early identification of safety issues and trial termination
improves patient safety
Data handling efficiencies
Virtual trials
…
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A Different Future…
Connect Healthcare and Research …
For more efficient use of patient data, to avoid redundant entry
and to improve trial performance
72%
70%
60%
50%
40%
30%
20%
10%
Of Benefit
• 72% of investigational
sites consider
connecting healthcare
and clinical trial
systems to be of
benefit!
80%
26%
3%
0%
Yes
No
Missing
Source: eClinical Forum Site Survey 2009, European data
17 July, 2015
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Why Now…
Political, Cultural & Technical Solutions are
Starting to Bridge the Gap
1. Political
FP7 ICT
Removing obstacles, linking
stakeholders and driving the
need for change
2. Cultural
Stakeholders see CR as a special case for
use of EHR data
3. Technical
Projects are developing solutions to
individual components
The concept has been proven in single
site, technology instances
17 July, 2015
IMI
BRIDG
EHRCR
Standards
Systems
Common data
Reliable,
standards allow
validated systems
movement of data
meet healthcare
Future
between
Connected
and research
healthcare and
Healthcare
&
requirements
research
Research
Munich
(InferMed:
Siemens)
Re-Use
Process
Controlled process for
release and transfer of
data meets bio-ethical
requirements
PACER
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Making It Happen… EHRCR
It is an important project to:
– Remove risk of clinical trial data rejection
because of unreliable source data
– Provide EHR system developers with the business
case and the clinical research functionality
– Help healthcare system implementers understand
the operational functionality required
– Provide sponsors and certification bodies with the
basis for evaluating EHR systems
EDC/eSource Taskforce
17 July, 2015
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Making It Happen… EHRCR
EuroRec
EHRCR
Functional
Profile
EHRCR User
Requirements
ANSI Standard
EHRCR FP
CCHIT
Certification of
EHRs for
Clinical
Research
UR
Mapping
Table
Clinical
Research
Regulations &
Guidances
CEN Standard
EHRCR FP
EU Certification
of EHRs for
Clinical
Research
HL7
EHRCR
Functional
Profile
17 July, 2015
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Key Messages…
1. The Pharma industry has always used PHR data
for clinical research (informed consent, anonymous, ethics
committees)
2. The growth of EHR presents opportunities for
– Research to improve clinical trial performance
– Healthcare to reduce redundant data entry
3. The environment is right to actively support and
make change happen
4. There are challenges but they can be met by
adapting and integrating existing technologies
and standards to achieve interoperability
5. The EHRCR project is an important initiative to
communicate functionality for Clinical Research
17 July, 2015
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Any Questions…
17 July, 2015
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Expectations of the
Pharma Industry
Regarding EHR
Systems
Richard Perkins
President, eClinical Forum
Tallinn
June 2010
About the eClinical Forum…
• A not-for-profit and non-commercial association
• 55 companies from Pharma R&D, service industries (eClinical system vendors, CROs,
consultancies etc),
academia, EHR.
• European & North American
• 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
Contributes Extensively To Information In The Public Domain
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
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