Enabling Clinical Research
Through Effective Use Of
Patient DataPerspective of the Researcher
Richard Perkins
President, eClinical Forum
Overview…
1. Some Relevant Statistics
2. A Different Future
3. The Challenge
4. Why Now
5. How EHRs Could Enhance
Clinical Research
To understand
the rationale,
needs,
challenges,
potential
solutions…
2
Some Relevant Statistics…
HealthcarePharma 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
>37,000 Clinical Trials
3
250,000 patients participate in
European clinical trials a year
Recruited by 4200 investigators
Completing ~1400 data points
per patient
A typical trial has 6000 data
queries (time and cost to
correct)
Generates 525-2025 M Euro for
healthcare
Physician /
Investigator
58% of trials do not meet
projected recruitment
rates!
Some Relevant Statistics…
Growth in Electronic Data Capture to 61% of
ongoing trials (from 13% in 2001)…
N=131
0%
5%
10%
15%
20%
25%
30%
35%
40%
0% 10% 20% 30% 40% 50% 60% 70% 80% 90% 100%
% R
es
po
nd
ers
Percentage of EDC Trials Ongoing at Site
No EDC Trials All EDC Trials
‒ To provide faster,
better quality and
more reliable data
to support safety
and efficacy
Source: eClinical Forum Site Survey 2009, European data
4
Average of 61%
of trials ongoing
at respondent
sites use EDC
37% only
use EDC
EU GPs (2008)
Some Relevant Statistics…
EU Hospitals (2004)
50%
Growth of EHRs to >50% …– Enhance patient safety
– Improve quality of healthcare
– Reduce healthcare costs
67-92%
5 Source: Benchmarking ICT use among General Practitioners in Europe, April 2008
Source: Personal communication - ICT use
among Hospitals in Europe, 2004
Some Relevant Statistics…
and… The percentage of patient data perceived
as entered into EDC system and the patient
record?
0%
10%
20%
30%
40%
50%
60%
70%
0 10 20 30 40 50 60 70 80 90 100
% R
esp
on
ders
Percentage Duplicated n = 124
Source: eClinical Forum Site Survey 2009, European data
70-100%!
6
A significant
opportunity for
efficiency gains!
In your opinion what percentage of data that was
entered into the CRF was also entered into the
patient file or notes?
A Different Future…
We Need… a common understanding and approach
We Need… to connect Healthcare and Pharma/Academic Research
7
A Different Future…
• 72% of investigational
sites consider
connecting healthcare
and clinical trial
systems to be of
benefit!
Connect Healthcare and Research …For more efficient use of patient data, to avoid redundant
entry and to improve trial performance
72%
26%
3%
0%
10%
20%
30%
40%
50%
60%
70%
80%
Yes No MissingO
f B
en
efi
tSource: eClinical Forum Site Survey 2009, European data
8
A Different Future…
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• 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.
Current Divided
Emerging and Future EHR-Research Connectivity and Complexity
Clinical Trial
System
Healthcare System
Imagine… Patient Data Exchange Between Healthcare and Drug Development Systems
Integrated Future •EHRs used to…
•Evaluate Patient Populations
•Accelerate Patient Recruitment
•Capture CT Data
•Exchange CT Data
•The EHR becomes the patient data repository
Integrated FutureInteroperable Ideal
9
A Different Future…
Benefiting all stakeholders…
Healt
hcare Identification of target population
Reduced effort for data provision leaves more time for patient care
Simplified safety reporting and managementPotential to conduct more research
Familiarity of one interface
Pati
en
t
New innovative therapies available earlier
Higher quality data provides greater safety
Real-time identification of safety issues and trends A
uth
ori
ties Higher quality, reliable data
from validated sources under investigator control
Lower cost and faster approval of new therapies
Mining of data
Ph
arm
aR
esearc
h 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 efficienciesVirtual trials…10
Healthcare Pharma Research
The Challenge…
Entry of
Patient’s Clinical
Data
Multiple systems, semantics, ontologies, languages…
Various levels of system validation and integration,
unstructured information…
Need for controlled process for release and transfer of
data to meet ethical and data protection requirements…
Source data held in EHR may not be appropriate as
source for regulated clinical studies …
Various standards, levels of system validation and integration, data structure depending on country,
region, institution.
Systems validated & compliant to Industry & Regulatory standards &
policies e.g. CSUCI, ICH GCPPhysician /
Investigator11
1. PoliticalRemoving obstacles, linking
stakeholders and driving the need for change
Why Now…
Political, Cultural & Technical Solutions are Starting to Bridge the Gap
Future Connected
Healthcare & Research
StandardsCommon data
standards allow
movement of
data between
healthcare and
research
SystemsReliable,
validated
systems meet
healthcare and
research
requirements
ProcessControlled process for
release and transfer
of data meets bio-
ethical requirements
HANYS
FP7 ICT IMIBRIDG EHRCR
Munich
(InferMed:
Siemens)
APHP/
INSERM
2. CulturalStakeholders see CR as a special
case for use of EHR data
3. TechnicalProjects are developing solutions to
individual components
The concept has been proven in
single site, technology instances12
13
Platform
Integrated Technology
and Interoperability
Layer
How EHRs Could Enhance CR…
Via a standardised, scalable platform that connects healthcare and drug development systems…
« Intelligent » computer-readable
protocols automate querying to
evaluate patient populations,
data collection, rules etc
Extended semantic and ontological
directories cover research
archetypes in multiple languages
Standardised interfaces support
multiple data exchange
standards for healthcare and
research
HL7 Messages
Edifact Messages
EN13606 Extracts
Proprietary Formats
Hea
lth
ca
re E
nvir
on
me
nt
2-way exchange of pseudo-
anonymised data eliminates
redundant entry
Use of standard infrastructure allows
for multiple CT service providers
Patients can be connected to
clinical trials to improve
recruitment
Ph
arm
aE
nviro
nm
en
t
Patient Population Query
Anonymised Aggregated Data Extracts
CT Patient Datafrom/to EHR
Data Exchange
Data Collection Quality Rules
SAE
How EHRs Could Enhance CR…
… operating within a sustainable business model
HL7 Messages
Hea
lth
ca
re E
nvir
on
me
nt
Organisation• Role of Ethics Committees, TTPs etc
• Governance and oversight
• Support infrastructure
Process• Qualification/certification
• Revenue , investment and cost models
• Workflow of activities, interfaces, rules
Edifact Messages
EN13606 Extracts
Proprietary Formats
Platform
Integrated Technology
and Interoperability
Layer
Business Model
Data protection and ethics
requirements met
14
Patient Population Query
Anonymised Aggregated Data Extracts
CT Patient Datafrom/to EHR
Data Exchange
Data Collection Quality Rules
Ph
arm
aE
nviro
nm
en
t
SAE
Qualification of systems,
processes, organisations
balance cost and oversight
Revenue and cost models
define value-added and ROI
to drive sustainability
Key Messages…
1. The more efficient re-use of EHR data presents opportunities for
• Healthcare to reduce redundant data entry
• Research to improve clinical trial performance
2. The concept has already been proven in single site and technology pilots
3. There is a political expectation for integration of healthcare and pharma/academic data (FP7 ICT, IMI)
4. The environment is right to actively support and make change happen
15
Key Messages…
5. There are challenges but they can be met by adapting and integrating existing technologies and standards to achieve interoperability
16
6. A sustainable European business model to facilitate re-use of patient data is needed that meets business, operational, ethical and data protection requirements
Enabling Clinical Research
Through Effective Use Of
Patient DataPerspective of the Researcher
Richard Perkins
President, eClinical Forum