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PONTE

Efficient Patient Recruitment for Innovative Clinical Trials of Existing Drugs to other Indications

Keywords: Health  Software Services Technologies  Semantics  Dissemination  Software and System Engineering  7th Framework Program  Europa  On going  Coordinator 

Background

Data collection on potential application to new diseases and disorders is increasingly considered to be mainly a mean for evaluating the effectiveness of new medicine and pharmaceutical formulas and for experimenting on existing drugs and their appliance to new diseases and disorders. The latter is due to the crisis that is being noticed in the pharmaceutical research and the world economy shrinking, causing reduction in new research funding and the practice of re-positioning existing medications for new uses.

However, benefits expected may also be limited by the presence of side effects and new efficacies may be missed in the trial. Translation into clinical therapy also has to overcome barriers at the preclinical and clinical levels. Thus, bridging basic science to clinical practice comprises a new scientific challenge which can result in successful clinical applications with low financial cost. In addition to the aforementioned context, the results yielding from clinical trials are dependent on the availability of clinical and molecular data and access to patients.

Project’s Objectives

PONTE, "Efficient Patient Recruitment for Innovative Clinical Trials of Existing Drugs to other Indications", aims at providing a platform following a Service Oriented Architecture (SOA) and Semantic approach that will offer automatic intelligent identification of patients eligible to participate within well-specified clinical trials for drug repositioning with specific focus on mitigating patient safety risks, reducing clinical trial costs and improving clinical trial efficacy. Work towards this direction involves decision support mechanisms fed with information retrieved from a semantic search engine. The latter operating on top of a data representation linking data within drug and disease knowledge databases, clinical care and clinical research information systems.

CETIC Key Responsibilities

  • Standardisation activities: continuous interaction with the activities of e-health related international standards, and particularly in the area of semantic interoperability between clinical research and clinical care information systems to the international standardisation activities.
  • Data representation and organisation: semantic data and metadata representations for clinical trials in order to support interoperability of clinical care information system data, enabling search, data mining and advanced machine learning across clinical care information systems following an SOA approach.
  • Finally, as coordinator of the project, CETIC is responsible for the overall management with a focus on quality assurance tasks.

Main Achievements

PONTE will provide four main outcomes:

  1. Consistent linking of clinical research information systems with clinical care information from Electronic Health Records (EHRs) through the development of a Semantic Specification Language. An innovative Ontology-Based Search Engine able to mine information based on this semantic data representation. Development of mechanisms that automatically identify the semantic information of schemas and detect semantic relationships between the distributed databases constructs. Combination of ontology-driven data integration and text mining techniques to enable the mining of information required from the various heterogeneous data sources involved.
  2. Integration of a wide spectrum of existing clinical data standards into an innovative core ontology-driven scheme that encompasses the entire clinical research and clinical care processes within the PONTE purposes. Scalability is considered to be of major importance, the proposed platform will be implemented following the SOA concepts.
  3. Advanced authentication and data confidentiality techniques will be incorporated, whereas usage control techniques will be explored for providing access control services as well as privacy protection services.
  4. Current legislation related to access and use of patient health data for the purposes of the PONTE platform among other legal issues will be investigated and will guide the PONTE architecture through the project duration

Partners

CETIC (Coordinator) Belgium
Technische Universität Dresden (TUD) Germany
Institute of Communications and Computer Systems / National Technical University of Athens (ICCS / NTUA) Greece
National Research Council-Institute of Clinical Physiology (CNR) Italy
Institute of Psychophysiology & Rehabilitation of the Kaunas University of Medicine (IoPR) Lituanie
Addenbrooke’s Hospital, Cambridge University Hospitals NHS Foundation Trust Royaume Uni
University of Athens (UoA) Grece
Gottfried Wilhelm Leibniz Universitaet Hannover (LUH) Germany
Strategic Medicine Inc Netherland

Factsheet

Project short name PONTE
Project full name Efficient Patient Recruitment for Innovative Clinical Trials of Existing Drugs to other Indications
Website www.ponte-project.eu
Type of project Europa - 7th Framework Program - ICT - STREP
CETIC budget 694,875 €
Duration 2010-2013

Project team: Arnaud Michot, Fabrice ESTIEVENART, Joseph Roumier, Nikolaos MATSKANIS, Philippe MASSONET