CORDIS proporciona enlaces a los documentos públicos y las publicaciones de los proyectos de los programas marco HORIZONTE.
Los enlaces a los documentos y las publicaciones de los proyectos del Séptimo Programa Marco, así como los enlaces a algunos tipos de resultados específicos, como conjuntos de datos y «software», se obtienen dinámicamente de OpenAIRE .
Resultados aprovechables
Laboratory testing in clinical trials can be performed at the investigative sites (local testing), by referral of samples to a central clinical laboratory (central) or by local testing with additional data management services (virtual testing).
Virtual central laboratory testing combines the advantages of local and central testing. The key benefits of this method are
- those of central and local laboratories;
- Reduction of pre-analytical bias and error due to site monitoring and
- Real cost savings. So far the laboratory concept was only tested and implemented in the Netherlands and in the UK with national phase IV (post-registration) and small scale phase II studies. The main market for central laboratory testing consists of large phase II and II clinical research projects. These projects have a multination and often even global scope. Since VCL`s services have only been implemented locally, its system is not yet developed to serve these projects.
The innovations of our development project are:
a) Improvement of information technology capabilities: multi-language capabilities, interfacing with local laboratory systems, increased customization of reporting.
b) Development of a Europe-wide network structure.
c) Upgrading of the actual calibrator types to support conversion of more tests.
d) Development of new calibrator types to support conversion of more tests.
e) Validation of Laboratory data conversion technology for use on a Europe-wide scale
Qualitative improvements of implementation of the VCL concept are
- reduction of inter-laboratory variation in studies where central laboratories are infrequently used due to ethical considerations (oncology, critical care),
- integration of patient care data and laboratory data at laboratory sites,
- reduction of pre-analytical variations and
- availability of common calibrators and reference ranges to normalize healthcare laboratory data.
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