p-medicine/ECRIN Collaboration Workshop took place in Paris, France (ECRIN Office) on June 11, 2015
p-medicine has dedicated the past 4.5 years to creating an infrastructure that will facilitate the translation from conventional medical practice to personalized medicine in the area of cancer research. Now, in its final phase, p-medicine takes measures to ensure that software solutions developed within the project will be used after the end of the project and will be taken up by researchers to be used and developed further. In order to find possibilities to increase the sustainability by collaboration a p-medicine/ECRIN workshop was held on June 11, 2015 in Paris, France. ECRIN (European Clinical Research Infrastructures Network) is an infrastructure that supports international clinical trials by providing a network of distributed groups and it seems to be the ideal partner for p-medicine to employ and support p-medicine tools and to use them in clinical trials (http://www.ecrin.org).
Three integrative scenarios from p-medicine with relevance for clinical trials were presented at the workshop:
- ObTiMA for data collection in clinical trials and biobank access
- Data integration by data warehouse and semantic annotation
- Sharing of DICOM images for second opinion
These demonstrations showed that the strength of p-medicine lies in its integrative solutions; but also that integrative solutions need more adaption, configuration and training than the employment of single purpose software.
To guarantee the sustainability of p-medicine’s results after the end of the project it is necessary to set up a kind of organizational structure that is able to provide support, service, training, and education to be founded under the name of STaRC (Study Trial and Research Centre: http://eu-starc.eu). STaRC can help in the search for funding and sponsorship as well as in the provision of committees and boards. Its overall aim is to maintain the p-medicine infrastructure and software tools and to support investigators in academic trials employing these tools. However, the hosting and maintenance of software solutions entails considerable costs. Different options are currently discussed on how to solve these financing issues. For example, ObTiMA, the ontology-based clinical trial management system intended to support clinicians in both designing and conducting clinical trials should eventually become the heart of STaRC and several cost models for ObTiMA like Open Source, or a fee for each patient enrolled in a clinical trial have been considered. Nonetheless, a satisfying not-for profit cost model is still being developed. In addition, it should be considered that ObTiMA is not only a tool, but is part of a legal framework consisting of pseudonymisation, contracts between data user/data provider and informed consent management, all being important for clinical trials in personal medicine. In the course of the project, p-medicine has developed a concept for the employment of p-medicine tools in ECRIN for the mutual benefit by reciprocal exchange of services.
It was agreed that it is most important at the current state to employ p-medicine tools in real clinical trial situations to gain experience and improve the tools. ECRIN can support p-medicine in reaching this goal. For this purpose, software must be validated for GCP compliance and a reference installation to evaluate these tools should be available and accessible via the ECRIN website. In this way, it can be demonstrated that ObTiMA and the other tools can be used efficiently and safely in clinical trials for collecting molecular, imaging, and clinical data. The development and provision of the reference installation should be run in parallel to the testing and validation efforts by ECRIN. These efforts should be complemented by a joint effort to receive long-term funding.
