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

3rd annual EHTEL Conference Dimitrios Venizeleas

THANK YOU!

Dimitrios Venizeleas

venisele@uni-duesseldorf.de