Perspective of the Researcher. Perkins R. eHealth week 2010 (Barcelona: CCIB Convention Centre; 2010)

1. Enabling Clinical Research
Through Effective Use Of
Patient Data
Perspective of the Researcher
Richard Perkins
President, eClinical Forum

2. Overview…
1. Some Relevant Statistics
To understand
2. A Different Future
the rationale,
needs, 3. The Challenge
challenges,
potential 4. Why Now
solutions… 5. How EHRs Could Enhance
Clinical Research
2

3. Some Relevant Statistics…
Pharma Research Healthcare
Bringing a new treatment 250,000 patients participate in
to the market costs >800 M European clinical trials a year
Euro and increases at
Recruited by 4200 investigators
~10% a year
Completing ~1400 data points
Clinical research uses 55-
per patient
75% of R&D budget
A typical trial has 6000 data
>37,000 Clinical Trials
queries (time and cost to
58% of trials do not meet correct)
projected recruitment Generates 525-2025 M Euro for
rates! healthcare
Physician /
3 Investigator

4. Some Relevant Statistics…
Growth in Electronic Data Capture to 61% of
ongoing trials (from 13% in 2001)…
40% Average of 61%
35% of trials ongoing ‒ To provide faster,
at respondent
30%
sites use EDC
better quality and
% Responders
25% more reliable data
20% 37% only
use EDC
to support safety
15%
and efficacy
10%
5%
0%
0% 10% 20% 30% 40% 50% 60% 70% 80% 90% 100%
Percentage of EDC Trials Ongoing at Site
No EDC Trials All EDC Trials
Source: eClinical Forum Site Survey 2009, European data N=131
4

5. Some Relevant Statistics…
Growth of EHRs to >50% …
– Enhance patient safety
– Improve quality of healthcare EU Hospitals (2004)
– Reduce healthcare costs
50%
EU GPs (2008)
67-92%
Source: Personal communication - ICT use
among Hospitals in Europe, 2004
5 Source: Benchmarking ICT use among General Practitioners in Europe, April 2008

6. Some Relevant Statistics…
and… The percentage of patient data perceived
as entered into EDC system and the patient
record? 70%
In your opinion what percentage of data that was
60% entered into the CRF was also entered into the
patient file or notes?
% Responders 50%
70-100%! 40%
30%
20%
A significant 10%
opportunity for 0%
0 10 20 30 40 50 60 70 80 90 100
efficiency gains! Percentage Duplicated n = 124
Source: eClinical Forum Site Survey 2009, European data
6

7. A Different Future…
We Need…
a common
understanding
and approach
We Need…
to connect
Healthcare and
Pharma/Academic
Research
7

8. A Different Future…
Connect Healthcare and Research …
For more efficient use of patient data, to avoid redundant
entry and to improve trial performance
80%
72%
• 72% of investigational 70%
Of Benefit
60%
sites consider 50%
connecting healthcare 40%
and clinical trial 30%
26%
20%
systems to be of 10%
benefit! 0%
3%
Yes No Missing
Source: eClinical Forum Site Survey 2009, European data
8

9. 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 • EHRs used to… Interoperable Ideal
• EHR systems holding source for data used in • EHR and research systems work
clinical trials may not meet essential regulatory • Evaluate Patient Populations seamlessly together so that groups
• Accelerate Patient Recruitment
requirements benefit from data access and mining
• Clinical care data required for clinical trials is capabilities across healthcare and
• Capture CT Data
entered into EHR and into clinical trial systems research data sets
• Research holds source data not part of normal • Research systems and healthcare
• Exchange CT Data
clinical care systems sit on the same spine
• Redundant data entry, transcription errors and • Systems conform to the same data
• The EHR becomes the patient data repository
source issues cost healthcare and industry exchange standards
time and money.
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10. A Different Future…
Benefiting all stakeholders…
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
New innovative therapies Higher quality, reliable data
Patient
available earlier from validated sources
Higher quality data provides under investigator control
greater safety Lower cost and faster approval of
Real-time identification of new therapies
safety issues and trends Mining of data
PharmaResearch
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
10 …

11. The Challenge…
Healthcare Pharma Research
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 …
Entry of
Patient’s Clinical
Data
Various standards, levels of system Systems validated &
validation and integration, data compliant to Industry &
structure depending on country, Regulatory standards &
region, institution. Physician / policies e.g. CSUCI, ICH GCP
Investigator
11

12. Why Now…
Political, Cultural & Technical Solutions are
Starting to Bridge the Gap
1. Political FP7 ICT IMI
BRIDG EHRCR
Removing obstacles, linking
stakeholders and driving the Standards Systems
Common data Reliable,
need for change standards allow
validated
movement of
Future systems meet
2. Cultural data between
healthcare and Connected healthcare and
Healthcare &
Stakeholders see CR as a special research research
Research requirements
case for use of EHR data Munich
(InferMed:
3. Technical Siemens) Process
Controlled process for
Projects are developing solutions to APHP/ release and transfer
individual components INSERM of data meets bio-
ethical requirements
The concept has been proven in
HANYS
single site, technology instances
12

13. How EHRs Could Enhance CR…
Via a standardised, scalable platform that connects
healthcare and drug development systems…
Standardised interfaces support « Intelligent » computer-readable
Extended semantic and ontological
multiple data exchange protocols automate querying to
directories cover research
standards for healthcare and evaluate patient populations,
archetypes in multiple languages
research data collection, rules etc
Platform
Patient Population
Healthcare Environment
Query
Pharma Environment
HL7 Messages
Anonymised
Integrated Aggregated Data Extracts
Edifact Messages Technology Data Collection
Quality Rules
and
EN13606 Extracts Interoperability CT Patient Data
from/to EHR
Layer SAE
Proprietary Formats
Data Exchange
2-way exchange of pseudo- Patients can be connected to
Use of standard infrastructure allows
anonymised data eliminates clinical trials to improve
for multiple CT service providers
redundant entry recruitment
13

14. How EHRs Could Enhance CR…
… operating within a sustainable business model
Business Model
Platform
Patient Population
Healthcare Environment
Query
Pharma Environment
HL7 Messages
Integrated Anonymised
Technology Aggregated Data Extracts
Edifact Messages and Data Collection
Quality Rules
Interoperability
EN13606 Extracts Layer CT Patient Data
from/to EHR
SAE
Proprietary Formats Qualification of systems, Revenue Data Exchange
and cost models
Data protection and ethics
processes, organisations define value-added and ROI
requirements met
balance cost and oversight to drive sustainability
Organisation Process
• Role of Ethics Committees, TTPs etc • Qualification/certification
• Governance and oversight • Revenue , investment and cost models
• Support infrastructure • Workflow of activities, interfaces, rules
14

15. 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

16. Key Messages…
5. There are challenges but they can be met by
adapting and integrating existing technologies
and standards to achieve interoperability
6. A sustainable European
business model to
facilitate re-use of patient
data is needed that meets
business, operational, ethical and
data protection requirements
richard.perkins@con7.com
16

17. Enabling Clinical Research
Through Effective Use Of
Patient Data
Perspective of the Researcher
Richard Perkins
President, eClinical Forum