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
Recommendations from STREAM A. Interaction Model
Isabelle de Zegher, co-chair, Novartis, EFPIA
Georges De Moor, co-chair, EUROREC
Marc Peeters, rapporteur, Roche, EFPIA
Table of contents
1. Scope and objective 2
1.1 Background 2
1.2 Details on use case 3
1.2.1 Patient recruitment 3
1.2.2 Electronic data capture 4
1.2.3 Safety 4
2. Summary of key discussion points 5
2.1 Common Issues 5
2.1.1 Source & quality (completeness & accessibility) of data: 5
2.1.2 Usage of data for “commercial” purpose 5
2.1.3 Workflow: how to ensure seamless integration 5
2.2 Third Party 6
2.3 “Business case” 6
2.4 Framework for interaction 6
3. Recommendations 8
3.1 Develop Service definition for EHR usage 8
3.2 Communication on eHR use and benefits: 8
3.3 Third party: 8
3.4 Collaboration forum: 9
3.5 Roadmap 9
3.5.1 2008 Milestones description 9
3.5.2 2009 Milestones description 10
4. Conclusion and next steps 10
5. Appendices 11
5.1 Agenda 11
5.2 Participants to the STREAM 13
5.3 Details from Brainstorming session 14
5.3.1 Service Definition 14
5.3.2 Communication 15
5.3.3 Third Party 16
5.3.4 Common Discussion Forum 16
5.3.5 Roadmap 17
1. Scope and objective
1.1 Background
There are about 15 different use cases for the potential usage of EHRs in the context of clinical research as indicated in the following figure (source: Slipstream project). There are no evident quick wins, but some use cases are more feasible than others.
Today however there is insufficient communication: clinical care and clinical research are two totally separate “electronic worlds” (except for some aspects of EDC) that would benefit by “breaking the wall” to get to real electronic data exchange
To break the wall, technology and technical standards (discussed in Stream B) are necessary but not sufficient. We need as well to clarify the legal hurdle (discussed in Stream C) and the organizational aspects, including financial aspects.
Benefits of EHR integration for clinical research are MAJOR; but the costs are ALSO major if we keep the current interaction model: “one hospital/one sponsor” , representing “n to m” electronic interfaces.
The basic questions that were addressed to the team A are:
§ How to adapt interaction models & processes to ensure benefit at affordable cost?
– Should internal processes change both in providers & sponsors organization ?
– Should we define new roles and new skills ?
– Should we put in place new actors such as a third party ?
§ How to build a common vision across Health Care to implement these changes
– How can we build a shared understanding of the needed changes
– How can we build a communication forum across Health Care to ensure effective implementation ?
1.2 Details on use case
Three use cases were proposed to the participants – with more specific questions
§ Patient recruitment
§ Electronic data capture
§ Safety
1.2.1 Patient recruitment
Scope
There are different components in patient recruitment
§ Evaluation of protocol feasibility based on availability of patient population as specified by inclusion/exclusion (i/e) criteria. The ability to do this more effectively before starting a study allows more “feasible” protocols to be designed and therefore to move faster in trials
§ Identification and enrollment of investigators who have patients with identified i/e criteria. There is no benefit to this step – taken alone; identification of patient and investigator does not guarantee actual patient recruitment.
§ Actual enrollment of patient within a study – following evaluation of i/e criteria
Potential changes required for more effective use of EHR
§ New roles and processes
– Within sponsors, there is a need to generate protocols in a more“structured” way (i.e. with computable i/e criteria that can easily be checked across different EHRs)
– Increase IT skills/collaboration during the whole process
§ Would a third party be useful?. If yes which type, which services ?
– A third party could decrease constraints related to privacy issues (this needs to be verified by Stream C)
– A third party could decrease cost of technical integration (going from “n to m” interfaces to only m)
– A third party could provide additional services (act on behalf of caring physician,…) to speed up the process
1.2.2 Electronic data capture
Scope/Issues.
Today it is estimated that about 80% of the data needed for clinical research are already collected in clinical care (paper or electronic format). How can we have easier access to these data, what about the additional “new” data (integration and ownership)?
Potential changes
§ New roles and processes
– Should we have a tighter integration of clinical care and clinical research processes within the provider organizations ?
– How to “seamlessly” adapt EHR for “new” data acquisition ?
– Any changes in the role of CRA versus investigator ?
§ Would a third party be useful. If yes , which services ? Would it be another type of CRO ?
1.2.3 Safety
Scope
§ pre-launch versus post-launch
§ Signal detection versus Adverse Events reporting
Potential changes
§ How do we ensure that we have “validated” information on drugs ACROSS Europe to ensure correct imputation
§ To enable predictive safety with effective data mining – assuming data can be pooled and integrated within existing EHR databases – are the current types of organizations, skills and processes right ?
§ Do we really need to have electronic data exchange or should the sponsors work directly with the providers within their organization (no need for data exchange)
§ What is the impact on pharmacovigilance ? Should we revise the process ?
2. Summary of key discussion points
All presentations will be available at the following address
http://www.eurorec.org/EHRWorkshop/model.cfm?selection=model&actief=EHRWorkshop
(additional presentations from the other streams are also available at the same site).
In the following we only summarize key discussion points, consolidated during the workshop across the 3 uses case
2.1 Common Issues
2.1.1 Source & quality (completeness & accessibility) of data:
§ Data coming from providers/clinical care : most of the data are coming from billing
o Registry & billing (information available as well within payers): 90% in EU
o CPOE: 18% in Sweden… (if this is available + possible to do safety)
o Ambulatory eHR system: 2% in Sweden
o Clinical data repository: starting….
=> information – such as knowledge of AE - is available in text BUT NOT available in in structured form in EHRs.
=> possibility to increase with financial incentive ?
§ Data coming from clinical research (clinical researchers in provider organization, pharma)
o Clinical research data Clinical trial Data are there but not available – pharma would be open to make available protocol and meta-data (such as class side-effect) but not results DB
o What should be ready to share ? GTB DB from AMIA is not a success
Clinical care: GIGO (Garbage In Garbage out)
Clinical research: GIGO (Gold In Gold Out))
=> SIGO (Silver In – Gold Out)
2.1.2 Usage of data for “commercial” purposes
§ We need to identify better sources of available data => we do not even a catalog of data; need to have a typology of the data as well
§ Need to change mindset and culture: clinical research leads to improved care => it should not be considered as a “secondary” use !
§ Currently we need authorization to access the data for usage which is not the original use, e.g. Informed consent => takes time, puts excessive load on daily practice.
o We should put in place solutions such as preview mechanism, financial reward, work delegation possible
o Do we really need informed consent in a world where physicians and sponsor are “responsible” parties….
2.1.3 Workflow: how to ensure seamless integration
§ EHR versus eCRF: How to ensure seamless integration of clinical care and clinical research as a continuum rather than two different entities with redundant patient data entry
§ How to monitor data for AE that will come in the future => how to ensure that data from clinical research are integrated into clinical care (will be critical mostly for devices in the future)
2.2 Third Party
Different potential models for third parties (several already in place in Europe)
§ public : money from government;
e.g. GPRD: model of “real-world” data collected longitudinal record
§ business (e.g. CRIX), public-private partnership, non –profit but self sustained
e.g. CRIX: model of sequencing: first efficacy and safety before launch and then monitoring
data collected as part of existing process
§ academic: research money (from grants and government)
e.g. Erasmus University Rotterdam – hospital
Which of the model offers the most trustworthiness and the highest quality of data (accuracy, completeness)?
Difficulties to set up a third party ?
§ political environment more difficult than technology !
§ technical integration and legal aspects - critical to have a Trusted Third Party to solve the different technical and legal aspects
§ feasible in the pharma/regulatory world – but for EHR integration would require gradual integration
Several third parties of different types already exist in Europe => need to make inventory . possibility of federation of existing third parties ?
What are the requirements/services for a third party
§ Technical integration
§ Legal “guardian”
§ Third party data can bring as well services to patients ? usage of patient as placebo data ?
§ Handles all data versus data on demand and build
§ Intermediate between hospital and payers
2.3 “Business case”
Benefits of EHR integration is potentially huge – faster and more efficient clinical development process, increase safety – but the cost of a fully scalable solution may be even higher unless we change the way we work.
Who makes the money ? when hospital and GP – and patients - become aware of the value of their data the model may change – however there is value on the data only if they are pooled not at individual level !
§ The society benefits NOT the individual
§ EU will work as there is collective health – in US it is the individual protection first however there is still a benefit to share the data
2.4 Framework for interaction
We need a paradigm shift
§ Quality of data : From low data, reactive high cost – to high data pro-active
§ Data mining – hypothesis testing can be possible – only if there is a strict governance process: how can we go hypothesis strengthening in the real word
§ Availability/sharing of data:
Definition of interaction model is composed of
· Description of the processes & workflow - where it applies (from end to end – with the need for change from the current situation to the future)
· Definition of Pre and post conditions
· Description of input and output (concepts and controlled terminologies)
Implementation of new interaction model will require a framework with
· Governance structure of transformation
· Budget – with realistic scope
· Organization & People and stakeholder management
· Technology infrastructure
3. Recommendations
Four focus areas were identified during the workshop and further elaborated. In the following we only provide a summary of the ideas (see appendix for further details)
3.1 Develop Service definition for EHR usage
Scope
§ Which type of services must be defined to allow for EHR integration.
§ How de we define and implement services, how do we get a holistic approach (people/process, technology and business case).
§ How can IT vendors be involved as a consortium (integrating EHR vendors and EDC vendors); need to clarify role of certification
§ We need to understand which type of data are available (catalogue of data ?)
§ We need to start with a pilot and get more input from pharma & health care (only one step but a piece of the puzzle) – define interaction model
§ Proposal is to support the CRFQ project (clinical research filter query – see presentation from Mead on site); with links between GPs, hospitals and vendors to ensure applicability of services like CRFQ across different computer systems
Practical next steps: start with a pilot building upon CRFQ to learn on how to work together for defining services in a more structured way
§ Evaluate implementation of a standard service such as Clinical Research Filtered Query (CRFQ). A request would be issued by a clinical research organization, be forwarded to Health Care providers (hospital, third parties like GPRD, other regional or national Databases) to evaluate patient population against specific criteria.
§ Evaluate business process changes in the context of protocol feasibility, patient recruitment and safety monitoring
§ Evaluate business case – benefits and cost for full implementation across the health Care chain
§ Evaluate how to work together as a Health Care “continuum” to further defined service in the clinical research area
3.2 Communication on EHR use and benefits:
Scope
§ One of the concerns is the time required to have patient approval for usage of data – communication on the value of using pooled/integrated EHR data should be communicated
§ We need to re-insure patient representatives/ press / media that there is nothing that should frighten the public in using their data
=> explain why we need access to data and decrease the worry
=> explain the semantic / decrease misunderstanding/emotions
Practical next steps: need to defined strategy and communication plan – no precise action taken yet
3.3 Third party:
Scope
We need to clarify the following aspects
§ what are the existing third parties in Europe,
§ how do we set up a third party in Europe,
§ what should be the business model
§ how to integrate services - like CRFQ - within third party and related process changes => will this accelerate the implementation ?