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3rd annual EHTEL Conference Dimitrios Venizeleas
Relevance of Open Source for Health Research
Dimitrios VenizeleasCoordinating centre for clinical trials,
Competence-/Reference centre for Open Source Clinical Trials Software
Heinrich-Heine-University Düsseldorf
3rd annual EHTEL Conference Dimitrios Venizeleas
Background
• German telematic platform of medical research networks (TMF)
• Networks of competence (disease oriented)
• Research networks for epidemic infections
• Coordinating centers for clinical trials
• Accelerate transfer from research to care
3rd annual EHTEL Conference Dimitrios Venizeleas
Coordinating centers for clinical trials
• Improve the quality of clinical trials in universities
• Increase the amount of that trials
• Implement standards (like GCP)
3rd annual EHTEL Conference Dimitrios Venizeleas
Software for clinical trials
• Tool for quality improvement
• Trial management
• Document management
• Metadata management
• Coding
• Electronic Data capture
3rd annual EHTEL Conference Dimitrios Venizeleas
Electronic data capture- Promises -
• Improved „time to market“
• Higher data quality
• Data cleaning more timely
• Less queries
• Less costs
3rd annual EHTEL Conference Dimitrios Venizeleas
Software for clinical trials- Challenges -
• Use of EDC will increase
• Pilots relatively common
• Full implementation difficult
• Strategic decision
3rd annual EHTEL Conference Dimitrios Venizeleas
Software for clinical trials- Problems -
• Software not standardized
• Ca. 50 vendors: who is credible?
• volatile industry-market consolidating
• Integration with other (legacy) systems
(e.g. registers, patient databases)
• Lack in interoperability
3rd annual EHTEL Conference Dimitrios Venizeleas
Open Source Software (OSS)
• Stability
• Security
• Peer review
• Extensibility
• Interoperability
• Integration
3rd annual EHTEL Conference Dimitrios Venizeleas
Current Situation
• Coordinating centres and competence networks: cooperative research activities
• Need of interoperability, integration
• Need of IT systems to support cooperative research activities
3rd annual EHTEL Conference Dimitrios Venizeleas
Software Evaluation- Results -
• Tailored to pharmaceutical industry
• Incompatibility
• No adaptability or customizing for users
• Immense total cost of ownership
3rd annual EHTEL Conference Dimitrios Venizeleas
System Implementation
• 2 systems (eRT, Macro) identified, implemented in 5 cooperatives
• OS software PhOSCo to be implemented in additional 5 cooperatives
• First trials already running
3rd annual EHTEL Conference Dimitrios Venizeleas
Competence-/Reference Center for OS software PhOSCo
• Subproject of the „system components“ working group
• Task: Support of the implementation of PhOSCo
• Development of a business model
3rd annual EHTEL Conference Dimitrios Venizeleas
Why PhOSCo?
• Production mature status
• Worldwide implementation by big pharma company
• Commercial support available (IBM)
• 2 years experience in KKS Düsseldorf
3rd annual EHTEL Conference Dimitrios Venizeleas
Why Open Source?
• Implementation in several cooperatives without license costs
• Customizing, modifying possible
• Complete knowledge transfer achievable
• No vendor lock-in
• Support provided by research partner
3rd annual EHTEL Conference Dimitrios Venizeleas
Open Source Framework for cinical trials
• Subproject of an EOI (IP) for the 6th EU Framework
• Specifications
• Refence implementations, Libraries, Tools
• Development below industry prices
