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Relevance of Open Source for Health Research

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. German telematic platform of medical research networks (TMF)

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Relevance of Open Source for Health Research

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  1. Relevance of Open Source for Health Research Dimitrios VenizeleasCoordinating centre for clinical trials, Competence-/Reference centre for Open Source Clinical Trials SoftwareHeinrich-Heine-University Düsseldorf

  2. 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 Background

  3. Improve the quality of clinical trials in universities Increase the amount of that trials Implement standards (like GCP) Coordinating centers for clinical trials

  4. Tool for quality improvement Trial management Document management Metadata management Coding Electronic Data capture Software for clinical trials

  5. Improved „time to market“ Higher data quality Data cleaning more timely Less queries Less costs Electronic data capture- Promises -

  6. Use of EDC will increase Pilots relatively common Full implementation difficult Strategic decision Software for clinical trials- Challenges -

  7. 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 Software for clinical trials- Problems -

  8. Stability Security Peer review Extensibility Interoperability Integration Open Source Software (OSS)

  9. Coordinating centres and competence networks: cooperative research activities Need of interoperability, integration Need of IT systems to support cooperative research activities Current Situation

  10. Tailored to pharmaceutical industry   Incompatibility No adaptability or customizing for users Immense total cost of ownership  Software Evaluation- Results -

  11. 2 systems (eRT, Macro) identified, implemented in 5 cooperatives OS software PhOSCo to be implemented in additional 5 cooperatives First trials already running System Implementation

  12. Subproject of the „system components“ working group Task: Support of the implementation of PhOSCo Development of a business model Competence-/Reference Center for OS software PhOSCo

  13. Production mature status Worldwide implementation by big pharma company Commercial support available (IBM) 2 years experience in KKS Düsseldorf Why PhOSCo?

  14. Implementation in several cooperatives without license costs Customizing, modifying possible Complete knowledge transfer achievable No vendor lock-in Support provided by research partner Why Open Source?

  15. Subproject of an EOI (IP) for the 6th EU Framework Specifications Refence implementations, Libraries, Tools Development below industry prices Open Source Framework for cinical trials

  16. THANK YOU!Dimitrios Venizeleasvenisele@uni-duesseldorf.de

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