1. Expectations of the Pharma Industry Regarding EHR Systems
24 November 2018
Expectations of the Pharma Industry Regarding EHR Systems
Helsinki Country: Finland Did You Know? Santa Claus
Northern lights
Lapland
Ice Hotel
Saunas
Helsinki ( listen (help·info); Swedish: Helsingfors, listen (help·info)) is the capital and largest city of Finland. It is in the southern part of Finland, on the shore of the Gulf of Finland, by the Baltic Sea. The population of the city of Helsinki is 577,928 (28 February 2009),[2] making it the most populous municipality in Finland by a wide margin. The foreign-born population stands at around 10%.
Helsinki, along with the neighbouring cities of Vantaa (Vanda), Espoo (Esbo), and Kauniainen (Grankulla), constitutes what is known as the capital region, with over 1,000,000 inhabitants. The Greater Helsinki area contains 12 municipalities and has a population of over 1,300,000.[2] The Greater Helsinki accounts for a quarter of the population of Finland, 29% of jobs, and a third of the GDP.
Helsinki is Finland's capital for business, education, research, culture, and government. Greater Helsinki has eight universities and six technology parks.[6] Some 70% of foreign companies operating in Finland have settled in the Helsinki region.[6] The immigration of rural residents has made it one of the fastest growing metropolitan areas in Europe.
Finland's main international airline hub, Helsinki-Vantaa Airport is 40 minutes from the city center, with direct flights around the world. The busy Helsinki–Tallinn route takes 1.5 hours by sea and 18 minutes by helicopter. Two other big cities in Finland, Tampere and Turku, can be reached in 1.5–2 hours by train[7] and 1.5–2.5 hours by car.
In early 2009, Helsinki has started contemplating a possible merger with Vantaa. On 30 March 2009, the city council of Vantaa agreed to do a review of Helsinki's proposal of a possible merger. The city council emphasises that the review is not about a possible discontinuation of the city of Vantaa.[8]
Richard Perkins
eClinical Forum
Tallinn
June 2010
Copyright eClinical Forum 2008

2. The Impact of eHealth on Clinical Trials
24 November, 2018
Overview…
Introduction
Use of EHRs in CR
Protocol Optimisation
Data Capture and Provision
A Different Future
Why Now
EHRCR
How EHRs are used today and their future potential for Clinical Research
24 November, 2018
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Copyright ConSept Consulting 2008

3. Introduction… EHR Growth to >50%
ConSept Consulting
Saturday, 24 November 2018
Introduction…
Physician /
Investigator
Healthcare
EHR Growth to >50%
Enhance patient safety
Improve quality of healthcare
Reduce healthcare costs
67-92%
Source: Benchmarking ICT use among General Practitioners in Europe, April 2008
EU GPs (2008)
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
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4. Protocol Optimisation…
Use of EHR Data to…
58% of trials do not meet projected recruitment rates!
49% increase in trial procedures
54% increase in trial workload
Pharma Research
Evaluate patient populations
Optimise inclusion/exclusion criteria
Assess feasibility of countries/sites
Patient identification (site)
The Challenge…
250,000 patients participate in European clinical trials a year
Recruited by investigators
Healthcare
Limited data that may not be representative
Difficulty to query (different formats)
Cost and time
24 November, 2018
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5. 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
Entry of
Patient’s Clinical Data
Physician /
Investigator
24 November, 2018
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6. 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
To provide faster, better quality and more reliable data to support safety and efficacy
37% only use EDC
In parallel the use of EDC has grown substantially in the last 8 years driven by our desire to improve clinical trial performance – for us!
Today 61% of ongoing trials in Europe (in the online survey sample used some form of EDC). 37% of responders are only doing EDC trials (grown from 8% in 2001). 9% aren’t currently participating in current EDC trials (73% in 2001)
No EDC Trials
All EDC Trials
Source: eClinical Forum Site Survey 2009, European data
N=131
24 November, 2018
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7. Data Capture… EHR Healthcare Pharma Research Physician / Investigator
Entry of
Patient’s Clinical Data
EHR
Physician /
Investigator 7
24 November, 2018
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8. The Impact of eHealth on Clinical Trials
24 November, 2018
Data Capture…
Healthcare and Pharma-centric Use of Technology is Creating an Source Issue for Clinical Trials
Traditional
Current
Research information is copied from healthcare records to pCRF. Healthcare retain source
Research information is copied to an electronic research environment. Sometimes with an interim paper step and hosting to provide healthcare ‘source’.
The Current Environment Results In…
Redundant data entry, inefficiency, reliability issues…
Source Data
Source Data
Paper
Medical
Record
Electronic
Medical
Record
Paper CRF
eCRF
But …
~30% of all clinical trials currently use EDC
Typical site may have 3 different EDC systems
Transcription from paper or electronic charts to EDC results in extensive duplication of data entry (~50%)
Replacement of backend
Increasing functionality (no longer Electronic ‘Data Capture’)
Trial Data
and Hosting
Paper CRF
24 November, 2018
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Copyright ConSept Consulting 2008

9. The eSource issue needs to be resolved
Data Capture…
The eSource issue needs to be resolved
13% of data for the EDC trial was first entered into the eCRF and is therefore ‘source’ within the EDC system
But…
11% of data was entered into a pCRF probably created to record source trial data not part of the patient’s site record
24 November, 2018
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10. Copyright eClinical Forum 2010
ConSept Consulting Capabilities
11/24/2018
Data Capture…
and… The percentage of patient data perceived as entered into EDC system and the patient record?
In your opinion what percentage of data that was entered into the CRF was also entered into the patient file or notes?
70-100%!
A significant opportunity for efficiency gains!
Source: eClinical Forum Site Survey 2009, European data
24 November, 2018
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11. 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.
Systems validated & compliant to Industry & Regulatory standards & policies e.g. CSUCI, ICH GCP
Physician /
Investigator 11
24 November, 2018
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12. Data Capture… Data Errors…
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
Healthcare
Completing ~1400 data points per patient
A typical trial has data queries (time and cost to correct)
Pharma Research
Cost of handling data queries - €60 million
24 November, 2018
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13. Copyright eClinical Forum 2010
24 November, 2018
A Different Future…
Imagine… Patient Data Exchange Between Healthcare and Drug Development Systems
Emerging and Future EHR-Research Connectivity and Complexity
Clinical Trial
System
Healthcare System
Integrated Future
Current Divided
Interoperable Ideal
Integrated Future
EHRs used to…
Evaluate Patient Populations
Accelerate Patient Recruitment
Capture CT Data
Exchange CT Data
The EHR becomes the patient data repository
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.
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
24 November, 2018
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14. Copyright eClinical Forum 2010
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
Patient
New innovative therapies available earlier
Higher quality data provides greater safety
Real-time identification of safety issues and trends
Authorities
Higher quality, reliable data from validated sources under investigator control
Lower cost and faster approval of new therapies
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 …
24 November, 2018
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15. Copyright eClinical Forum 2010
A Different Future…
Connect Healthcare and Research …
For more efficient use of patient data, to avoid redundant entry and to improve trial performance
72% of investigational sites consider connecting healthcare and clinical trial systems to be of benefit!
Of Benefit
Source: eClinical Forum Site Survey 2009, European data
24 November, 2018
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16. Munich (InferMed: Siemens)
Why Now…
Political, Cultural & Technical Solutions are Starting to Bridge the Gap
Political
Removing obstacles, linking stakeholders and driving the need for change
FP7 ICT
IMI
BRIDG
EHRCR
Future Connected Healthcare & Research
Standards
Common data
standards allow movement of data between healthcare and research
Systems
Reliable, validated systems meet healthcare and research requirements
Process
Controlled process for release and transfer of data meets bio-ethical requirements
Cultural
Stakeholders see CR as a special case for use of EHR data
Munich (InferMed: Siemens)
Re-Use
Technical
Projects are developing solutions to individual components
The concept has been proven in single site, technology instances
PACER
24 November, 2018
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17. Making It Happen… EHRCR
August 2007
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
It is an important project to:
Remove risk of clinical trial data rejection because of unreliable source data (e.g. FDA rejection 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 – ‘CR Ready’
Provide sponsors and certification bodies with the basis for evaluating EHR systems as source data repositories
EDC/eSource Taskforce
24 November, 2018
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18. Making It Happen… EHRCR
EuroRec
EHRCR Functional Profile
ANSI Standard EHRCR FP
CEN Standard EHRCR FP
EU Certification of EHRs for Clinical Research
CCHIT Certification of EHRs for Clinical Research
Clinical Research Regulations & Guidances
EHRCR User Requirements
UR Mapping Table
HL7
EHRCR Functional Profile
24 November, 2018
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19. Copyright eClinical Forum 2010
Key Messages…
The Pharma industry has always used PHR data for clinical research (informed consent, anonymous, ethics committees)
The growth of EHR presents opportunities for
Research to improve clinical trial performance
Healthcare to reduce redundant data entry
The environment is right to actively support and make change happen
There are challenges but they can be met by adapting and integrating existing technologies and standards to achieve interoperability
The EHRCR project is an important initiative to communicate functionality for Clinical Research
The concept has already been proven in single site and technology pilots
There is a political expectation for integration of healthcare and pharma/academic data (FP7 ICT, IMI)
24 November, 2018
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20. Copyright eClinical Forum 2010
Any Questions…
24 November, 2018
Copyright eClinical Forum 2010

21. Expectations of the Pharma Industry Regarding EHR Systems
24 November 2018
Expectations of the Pharma Industry Regarding EHR Systems
Helsinki Country: Finland Did You Know? Santa Claus
Northern lights
Lapland
Ice Hotel
Saunas
Helsinki ( listen (help·info); Swedish: Helsingfors, listen (help·info)) is the capital and largest city of Finland. It is in the southern part of Finland, on the shore of the Gulf of Finland, by the Baltic Sea. The population of the city of Helsinki is 577,928 (28 February 2009),[2] making it the most populous municipality in Finland by a wide margin. The foreign-born population stands at around 10%.
Helsinki, along with the neighbouring cities of Vantaa (Vanda), Espoo (Esbo), and Kauniainen (Grankulla), constitutes what is known as the capital region, with over 1,000,000 inhabitants. The Greater Helsinki area contains 12 municipalities and has a population of over 1,300,000.[2] The Greater Helsinki accounts for a quarter of the population of Finland, 29% of jobs, and a third of the GDP.
Helsinki is Finland's capital for business, education, research, culture, and government. Greater Helsinki has eight universities and six technology parks.[6] Some 70% of foreign companies operating in Finland have settled in the Helsinki region.[6] The immigration of rural residents has made it one of the fastest growing metropolitan areas in Europe.
Finland's main international airline hub, Helsinki-Vantaa Airport is 40 minutes from the city center, with direct flights around the world. The busy Helsinki–Tallinn route takes 1.5 hours by sea and 18 minutes by helicopter. Two other big cities in Finland, Tampere and Turku, can be reached in 1.5–2 hours by train[7] and 1.5–2.5 hours by car.
In early 2009, Helsinki has started contemplating a possible merger with Vantaa. On 30 March 2009, the city council of Vantaa agreed to do a review of Helsinki's proposal of a possible merger. The city council emphasises that the review is not about a possible discontinuation of the city of Vantaa.[8]
Richard Perkins
President, eClinical Forum
Tallinn
June 2010
Copyright eClinical Forum 2008

22. 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
formed in 2000 and registered in France