1. 3rd annual EHTEL Conference Dimitrios Venizeleas Relevance of Open Source for Health Research Dimitrios Venizeleas Coordinating centre for clinical trials, Competence-/Reference centre for Open Source Clinical Trials Software Heinrich-Heine-University Düsseldorf

2. 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

3. 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)

4. 3rd annual EHTEL Conference Dimitrios Venizeleas Software for clinical trials Tool for quality improvement Trial management Document management Metadata management Coding Electronic Data capture

5. 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

6. 3rd annual EHTEL Conference Dimitrios Venizeleas Software for clinical trials - Challenges - Use of EDC will increase Pilots relatively common Full implementation difficult Strategic decision

7. 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

8. 3rd annual EHTEL Conference Dimitrios Venizeleas Open Source Software (OSS) Stability Security Peer review Extensibility Interoperability Integration

9. 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

10. 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

11. 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

12. 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

13. 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

14. 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

15. 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

16. 3rd annual EHTEL Conference Dimitrios Venizeleas THANK YOU! Dimitrios Venizeleas venisele@uni-duesseldorf.de