Personalized medicine for clinical trials networks. The p-medicine project is presented. It deals with the creation of an integrative infrastructure for Personalised Medicine, which aims to accelerate personalized medicine and personal clinical research. For this purpose p-medicine developed a comprehensive set of software tools, including ObTiMA data management system, Patient Empowerment Tool, data mining, data warehousing, biobank access, decision support, image annotation (DrEye) and simulation (Oncosimulator). Here we show the evaluation of some of the p-medicine tools for their suitablity to perform clinical trials. Is their usage conform with regulations and standards (GCP, GDPR, GAMP, computer system validation)? Can these tools be integrated into the existing systems (IT infrastructure / organisational framework) of an international clinical trials network (ECRIN)? To perform clinical trials, a legal and ethical framework based on international requirements and approved concepts for data security must be adopted. GCP (Good Clinical Practice) is such an international ethical and scientific quality standard for designing, recording and reporting trials that involve the participation of human subjects. Evaluation of usability of p-medicine software tools for clinical trials was done with two surveys: (1) survey of p-medicine tools in the ECRIN network and (2) p-medicine developer survey. The tool integration topics contained questions about the employment of the right Clinical Data Management System (CDMS) at the many ECRIN centres. There is competition between different solutions, like VISTA (EORTC) MACRO, secuTrial, RAVE, OpenClinica. CDMS should be usable for all types of trials and the usability in clinical trials must be demonstrated by integration of biobank access / safety functions. Only ObTiMA is able to specifically address the challenges of personal medicine clinical trials. The results of the evaluation was that there exists some compliance gaps for quality management during software development, no complete GCP compliance yet and the missing of a robust business model for software sustainability. To address the latter, a Reciprocal Integration approach was developed to integrate p-medicine tools into clinical research networks.

1. Wolfgang Kuchinke
University of Duesseldorf (UDUS), Germany
3rd
EU Review Meeting, Brussels, Belgium
29.4.2014
Personalized medicine for clinical
trials networks

2. Content
• Overview over project deliverables
• Usability of personalized medicine
tools within the ECRIN clinical trials
infrastructure
• Evaluation of usability
• Results and recommendations
W. Kuchinke (2015)

3. p-medicine project
•
Creation of an Integrative Infrastructure for Personalised Medicine
•
FP7 project: From data sharing and integration via VPH models to
personalized medicine
•
IT infrastructure to accelerate personalized medicine and personal
clinical research, including personalized clinical trials
•
p-medicine developed a comprehensive set of tools, including
ObTiMA data management system, Patient Empowerment, data
mining, data warehousing, biobank access, decision support, image
annotation (DrEye) and simulation (Oncosimulator)
•
These tools will all interact with each other and be accessible
through a single web portal
•
Such a highly integrated infrastructure enables a new level of
information integration, but also raises new levels of ethical concerns

4. p-medicine infrastructure for
research in personal medicine

5. Task 6.2
• Interoperability of p-medicine tools has to be
guaranteed during clinical trial conduct
– Tools have to meet requirements and conform to regulations
(GCP, system validation)
• Integration of personalised medicine tools into
existing systems (IT infrastructure / organisational
framework) of an international clinical trials network
(ECRIN)
• Adoption of a legal and ethical framework based on
international requirements, approved concepts for data
security
GCP (Good Clinical Practice) is an international ethical and scientific
quality standard for designing, recording and reporting trials that involve
the participation of human subjects. Compliance with this standard
provides public assurance that the rights, safety and wellbeing of trial
subjects are protected and that clinical-trial data are credible.

6. Usability of p-medicine software
tools for clinical trials
• Evaluation of usability of an employment
of p-medicine tools in the ECRIN network
• Survey in ECRIN (D2.3)
• p-medicine developer survey
– Usability within the ECRIN infrastructure and
its processes
– Usability in a regulated area under GCP
requirements and with validated tools

7. Tool integration topics
• ECRIN centres have own CDMS
• VISTA (EORTC) development
• CDMS should be usable for all types of
trials
– Usable for personalised medicine and translational
medicine trials
• Usability in clinical trials must be demonstrated
• Integration of biobank access / Safety
functions with CDMS
• ObTiMA should be a complete CDMS and
extendable

8. Integration with CDMS
• A clinical data management system (CDMS) is a
tool used in clinical research to manage the
data of a clinical trial
• Clinical trial data gathered by the investigator
at investigator sites in case case report forms
(CRF)
• Many Clinical Data Management Systems
(CDMS) are available, like ORACLE CLINICAL,
CLINTRIAL, MACRO, RAVE, OpenClinica,
openCDMS, TrialDB.
• But there are no CDMS specifically addressing
the challenges of personal medicine clinical
trials

9. Approach for evaluation
W. Kuchinke (2015)

10. Main Compliance Areas

11. Summary of results
• p-medicine tools were mostly still in final
development at the time of the survey
• Technically all tools work safely together
• Gaps were detected
– Quality management during software
development
– Complete GCP compliance
– Robust business model for sustainability

12. • Quality Assurance not fully implemented
• Understanding of GCP-compliance has to
be improved, especially for software
developers
• Risk analysis / impact analysis for patient’s
safety should be more strict and complete
• Several features (e.g. query management,
data input control,…) for full GCP
compliance of Case Report Forms must be
implemented
Gap Analysis

13. Consequences
• Recommendations that may simplify the
employment of p-medicine tools in clinical
trials networks or with other future users
 Development of special guidance and
assistance for the rest of project lifetime
 Support of the evolution from “academic”
driven consortium solutions to professional
service and tool providing (e.g. STaRC)

14. Recommendations I
• The network ECRIN provides help to improve
integration capabilities of p-medicine tools
• Consideration of business and process level
– GCP training for developers / programmers
– Knowledge Transfer regarding Computer System
Validation
– Knowledge Transfer regarding international clinical
trials
– Knowledge Transfer about personal medicine
infrastructure

15. Recommendations II
• Business plan / Business continuity plan
– Support, help desk and training
– Validation support for integration into clinical research
infrastructure
– Business Continuity
• Agile Development requires Agile QA
– Risk assessment in development life cycle
• Build-in-Compliance

16. Reciprocal integration approach
W. Kuchinke (2015)

17. Thank you!
The presentation contains additional material for Q&A session.
Contact
Wolfgang Kuchinke
University Duesseldorf (HHU), Duesseldorf, Germany
e-mail: wolfgang.kuchinke@uni-duesseldorf.de
More information: http://www.p-medicine.eu/
W. Kuchinke (2015)