Enhancing clinical research
Brussels 11th and 12th October 2007
Primary and secondary use of EHR systems:
Enhancing clinical research for better health and high quality healthcare
October 11th and 12, 2007
BU33 0/54: Avenue de Beaulieu 33, 1160 Brussels
Additional break out rooms:BU29 0/08; BU29 7/63: Avenue de Beaulieu 29
BrusselsSeptember4th 2007
Dear Sir, Madam
The primary purpose of EHR systems is to increase quality and efficiency of clinical care. Secondary usage of interoperable EHRs includes clinical research and public health; it allows for increased efficiency in clinical research and opens new possibilities for data mining for patient safety, epidemiology and health economics research.
Generally healthcare stakeholders (clinicians and academia, IT vendors, pharmaceutical companies, authorities, payers and patients) have limited understanding of each other’s needs outside current processes and interaction. In clinical care, for example, there is limited knowledge about the clinical research requirements such as electronic data capture (EDC) during clinical trials, validation requirements when using computerised systems, activities of standardisation organisations such as ICH and MedDRA MSSO, etc. Conversely, there is limited experience within pharma world of clinical IT systems and solutions and health IT standards like HL7, ICD, SNOMED, etc.
It is time to bridge the gap!
Under to sponsorship of the European Commission, ICT for Health Unit, and the European Federation of Pharmaceutical Industries and Associations (EFPIA), with close cooperation of EUROREC and IT vendors, we would like to invite you to a “Think Tank workshop” with selected experts, representing the views of the different healthcare stakeholders.
The workshop will take place in Brussels on October 11th and 12th.
The objectives of the workshop are to scope the domain and to agree on practical recommendations with regard to further process. There are several areas that need to be considered in the context of secondary uses of EHR, from basic research to public health. It is suggested to cover the following three topics in relation to healthcare and clinical research:
A.Appropriateness or need for change of present interaction model, related processes and organisational components in order to optimise the benefits of EHR systems
B.Short-term practical solutions for data interoperability between direct patient care and clinical research
C.Privacy and other legal requirements
To ensure practical, realistic recommendations we expect the discussion on these three topics to focus on 3 specific use cases: 1) patient recruitment in clinical research, 2) electronic data capture (EDC) during clinical trials and 3) safety monitoring.
Please find enclosed more details on the program. We would appreciate if you could send us back the confirmation form at the end of this document.
Looking forward to welcoming you in Brussels!
Kind regards
Ilias Iakovidis Isabelle de Zegher
EC, DG Information Society and Media EFPIA
Deputy Head of Unit ICT for Health Chair EHR Task Force
Primary and secondary use of EHR systems:
Enhancing clinical research for better health
and high quality healthcare
October 11th and 12, 2007
BU33 0/54: Avenue de Beaulieu 33, 1160 Brussels
Additional break out rooms:BU29 0/08; BU29 7/63: Avenue de Beaulieu 29
ORGANISING COMMITTEE
European Commission / Ilias Iakovidis (ICT for Health)European Federation for Pharma Industry Association (EFPIA): / Jean Samuel (Pfizer),
Isabelle de Zegher (Novartis),
Mats Sundgren (Astra Zeneca)
Clinical Care: / Georges de Moor (Eurorec)
IT Vendors: / Gudrun Zahlmann (Siemens),
PetraWilson (CISCO)
eHealth Consultant: / Veli Stroetmann (empirica)
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/ Primary and secondary use of EHR:Enhancing clinical research
Brussels 11th and 12th October 2007
PROGRAM AT A GLANCE
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/ Primary and secondary use of EHR:Enhancing clinical research
Brussels 11th and 12th October 2007
DETAILLED PROGRAM (PRELIMINARY)
SESSION 1. PLENNARY SESSION.
Thursday 11th October (morning)
Location: BU33 0/54
Chair: Ilias Iakovidis
Time / Title / Speaker10:00 – 10:30
(30 min) / Primary and secondary use of EHR systems: Can one exist without the other?
Introduction to the workshop / I. Iakovidis
10:30 – 11:00 (30 min) / Pharma View / B. Tardiff
11:00 – 11:30 (30 min) / IT View / P. Jones
11:30 – 12:00 (30 min) / Health Care View / G. De Moor
12:00 – 12: 15
(15 min) / BREAK
12:15 – 12:35
(20 min) / Introduction to the “Interaction Models” session. Patient recruitment, electronic data capture and patient safety: do we need to change processes and roles ? / I. de Zegher
12:35 – 12:55
(20 min) / Introduction to the “Data Interoperability” session / J. Samuel
12:55 – 13:15
(20 min) / Introduction to the “Legal and Regulatory Challenges” session / P. Wilson
13:15 – 14:30
(1h15 min) / LUNCH
SESSION 2. PARALLEL SESSIONS
Thursday 11th October (afternoon)
ParallelSession2A: Interaction Models
Location: BU33 0/54
Chair: George De Moor, Isabelle de Zegher
Reporting: Marc Peeters
Time / Title / AuthorOverall introduction
14:30 – 14:45
(15 min) / Introduction to the session: participants and expectation / G. De Moor,
I. de Zegher
14:45 – 15:05
(20 min) / Lessons learnt on secondary usage of data from the UK NHS CRC study / J. Parkinson
15:05 – 15:25
(20 min) / Lessons learnt from CRIX, a third party in place in the US: interaction model, setting up, benefits and concerns of several months of operations / J. Bland
Focus on Patient recruitment. Patient recruitment: from today’s paper based process to “24 hours recruitment”” is a technology supported by process changes enough or do we need a third party to solve legal issues and technical heterogeneity.
15:25 – 15:45
(20 min) / Identifying and recruiting patients for clinical trials in the future: a pharma perspective / R. Thwaites
15:45 – 16:15
(20 min) / Hospital/Health care perspective / J. van der Lei
16:15 – 16: 30
(15 min) / BREAK
16:30 – 16:50 / IT perspective / C. Mead
16:50 – 17:15
(25 min) / Discussion and recommendations for actions / I. de Zegher,
G. De Moor,
Focus on Electronic data capture. Can EHR replace the need for eCRF, what is the impact on the investigator-clinical monitor roles
17:15 – 17:35
(20 min) / A detail on the process: pharma perspective / H. Donovan
17:35 – 17:45
(20 min) / Hospital/Health care perspective / C. Le Bozec
17:45 – 18:05
(20 min) / IT vendors perspective / JF Penciolelli
18:05 / Close of session
18:30 – 19:30 / Meeting Organizing Committee
BU33 0/54 / Organizing Committee
SESSION 3. PARALLEL SESSIONS
Friday 12th October (morning)
Session 3A. Parallel Session: Interaction Models
Location: BU33 0/54
Chair: George De Moor, Isabelle de Zegher
Reporting: Marc Peeters
Time / Title / AuthorFocus on Electronic data capture. Can EHR replace the need for eCRF, what is the impact on the investigator-clinical monitor roles
08:30 – 09:00
(30 min) / Discussion and recommendations for actions / G. De Moor,
I. de Zegher
Focus on Safety. Availability of EHR database and data warehouse: a new safety model ? impact on the current pharmacovigilance models ?
09:00 – 09:20
(20 min) / A detail on the process: pharma perspective / S. Markel-Fox
09:20 – 09:40
(20 min) / Hospital/Health care perspective / C. Lovis
09:40 – 10:00
(20 min) / IT vendors perspective / S. Payne
10:00 – 10:20
(20 min) / Authorities perspective / T. Buxton
10:20 – 10:40
(20 min) / BREAK
10:40 – 11:10
(30 min) / Discussion and recommendations for actions on safety / I. de Zegher,
G. De Moor
Consolidated recommendations (Identify person responsible for reporting during plenary)
11:10 – 12:30 (1h 20 min) / Key messages from the different focus areas
Consolidated recommendations
Practical next steps / G. De Moor,
I. de Zegher
12:30 / Close of session - LUNCH
SESSION 2. PARALLEL SESSIONS
Thursday 11th October (afternoon)
Parallel Session 2B: Data interoperability - short term practical solutions
Location: BU29 0/08
Chair: Jean Samuel, Gudrun Zahlman
Reporting: Jean Samuel
Time / Title / AuthorOverall introduction
Note: this session is organized in a more interactive mode – it is expected that ALL participants will actively participate to the brainstorming discussions throughout the workshop
14:30 – 14:50
(20 min) / Welcome and who’s who / J. Samuel
14:50 – 15:10 (20 min) / Outline of session and the process and build we will use / J. Samuel
What are the barriers, ‘pain points’ for ensuring progress on secondary use of EHRs ?
Sharing experience for real life perspective
15:10 – 15:25
(15 min) / IT perspective / C. Ohmann
15:25 – 15:40
(15 min) / The IT vendors perspective / E. Maurincomme
15:40 – 15:55
(15 min) / Clinical Research perspective / C. McGrath
15:55 – 16:10
(15 min) / Authorities/payers perspective / L. Wood
16:10 – 16:25
(15 min) / Healthcare perspective / P. Lambin
16:25 – 16:40
(15 min) / BREAK
Classification/ranking of the barriers and ‘pain points’ to semantic interoperability and secondary use of EHR
Brainstorming with all participants.
16:40-17:40 (1h) / Brainstorming
- Identification on barriers from presentations before, add further barriers if key
- Classification of barriers (value if solved versus difficulty) and ranking
ALL
17:40-18:00
(20 min) / Round up and identify any actions for next day / G. Zahlman
J. Samuel
18:05 / Close of session
18:30 – 19:30 / Meeting Organizing Committee
BU33 0/54 / Organizing Committee
SESSION 3. PARALLEL SESSIONS
Friday 12th October (morning)
Parallel Session 3B: Data interoperability - short term practical solutions
Location: BU29 0/08
Chair: Jean Samuel, Gudrun Zahlman
Reporting: Jean Samuel
Time / Title / AuthorPractical solution and recommendations for short term actions
Brainstorming with all participants
08:30- 09:30 (1h) / Two/three highest ranked barriers, “pain points”
- Identify know solution – how to ensure implementation at a larger scale
- Ideas generation for new solutions – how to implement, what is the feasibility, cost assessment
ALL
09:30-10:10 (40 min) / Explore other barriers
- Identify known solutions
- Ideas generation for new solutions
ALL
10:10 – 10:30
(20 min) / Tease out and rank the top 2 or 3 practical steps from previous discussions
10:30 – 10:50
(20 min) / BREAK
10:50-12:00 / Recommendations for actions: practical next steps, priorities, resources, key success factors
Prepare feedback to main session / G. Zahlman /
J. Samuel
12:05 / Close of session
SESSION 2. PARALLEL SESSIONS
Thursday 11th October (afternoon)
Session 2C. Parallel Session: Legal and regulatory challenges
Location: BU29 7/63
Chair: Petra Wilson, Mats Sundgren
Reporting: Peter Singleton, Celine van Doosselaere
Location: BU29 7/63
Chair: Petra Wilson, Mats Sundgren
Reporting: Peter Singleton, Celine van Doosselaere
Time / Title / AuthorOverall discussion
14:30 – 14:45
(15 min) / Introduction to the session: participants and expectation / M. Sundgren, P.Wilson
14.45 – 15.25 (40 min) / Regulatory perspective – setting the EU legal background / I. Andoulsi
15.25- 16.00 (35 min) / Protection of personal data: The view from the EU Commission / T. Zerdick
16.00- 16.15 / Q and A - in preparation for discussion / ALL
16:15 – 16: 30
(15 min) / BREAK
16.30 – 17.05 (35 min) / Pharmaceutical Industry Perspectives – what the industry needs / K. Heidenreich
16.30 – 17.05 (35 min) / Research Industry Perspective - the between legal regulation and the pharmaceutical research / D. Trower
17.40-18.00 (20 min) / Q and A - in preparation for discussion / ALL
18.00
(5 min) / Wrap of day 1 / M. Sundgren, P.Wilson
18:05 / Close of session
18:30 – 19:30 / Meeting Organizing Committee
BU33 0/54 / Organizing Committee
SESSION 3. PARALLEL SESSIONS
Friday 12th October (morning)
Session 3C. Parallel Session: Legal and regulatory challenges
Location: BU29 7/63
Chair: Petra Wilson, Mats Sundgren
Reporting: Peter Singleton, Celine van Doosselaere
Time / Title / AuthorOverall discussion
08.30-08.45
(15 min) / Introduction to the session: participants and expectation / P. Wilson,
M. Sundgren
8.45- 9.30
(35 min) / Technical perspective – meeting the technical security needs / F. de Meyer
9.30 – 10.20
(50 min) / Round table on legal issues - Speakers of day 1 plus other nominated – each to present key proposals for recommendation / All Speakers
10:20 – 10:40 (10 min) / BREAK
10.40 -12.00 (1h 20 min) / Open discussion / ALL
Consolidated recommendations
12:00 – 12:30 (30 min) / Key messages from the different focus areas
Consolidated recommendations
Practical next steps / P. Singleton
12:30 / Close of session – LUNCH
SESSION 4. PLENNARY SESSION
Friday 12th October (afternoon)
Location: BU33 0/54
Chairs: Georges De Moor, Jean Samuel, PetraWilson
Reporting: Isabelle de Zegher, Marc Peeters
Time / Title / Author13:30 – 14:15
(45 min) / Report on the “Interaction models” session.
Discussion on proposed recommendations and next steps / Nominated reporting person from session
14:15 – 15:00 (45 min) / Report on the “Data interoperability” session.
Discussion on proposed recommendations and next steps / Nominated reporting person from session
15:00 – 15: 15
(15 min) / BREAK
15:15 – 16:00
(45 min) / Report on the “Legal and regulatorychallenges” session.
Discussion on proposed recommendations and next steps / Nominated reporting person from session
16:00 – 16:30
(30 min) / Closing remarks / I. Iakovidis
I. de Zegher
16:30 / CLOSE OF WORKSHOP
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/ Primary and secondary use of EHR:Enhancing clinical research
Brussels 11th and 12th October 2007
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