Network Head Office &
DNA- and blood sample bank

The Network Head Office is responsible for network organisation, communication with industrial partners, establishment of a new legal form for ensuring the sustainability of the DFNS, public relations and updating the website. A permanent network headquarter is going to be established in the following years with industrial funding.

Moreover, a blood sample data base has been established. The rationale is that with the huge clinical data base on neuropathic pain symptoms and signs, the collection of corresponding individual DNA- and blood serum probes offers an unique opportunity for association studies on candidate genes and proteomics. The next tasks of the DNA- and blood sample bank are DNA extraction and further DNA analysis. Since up to date sufficient samples could be obtained, the next steps in further DNA analysis besides extraction and storage of the samples will be polymorphism analysis and correlation analysis between QST-phenotypes and genotypes.

Neuropathic pain data base

The central Integrative Network Project of the German Research Network on Neuropathic Pain is a Neuropathic Pain Data Bank. All network participants subserve the data bank with standardized information of each patient regarding socio-economic, psycho-social, psychological data and results of quantitative sensory testing (QST). The data is centrally coordinated by a data management system for documentation and quality assurance. The tasks in the new funding period are:

• modification and review of the multicenter database system "neuromodule" (QUAST)
• adjustments for new diagnostic groups
• development and review of algorithms for largely automatic processes concerning data input, quality control and routines for evaluation
• support of the extension and optimization of an efficient central database
• database analysis with respect to the development of cluster models and diagnostic tools for identification of patterns in neuropathic constellations

Quality Management Center

In order to translate the mechanism-based concept into clinical reality it is important to establish clinical tests that define the individual underlying pathophysiological mechanism. Since sensory signs and special pain types are closely related to the underlying mechanisms, clinical assessment of the signs can give a clue of the distinct mechanisms that operate in one individual patient. By using a battery of several standardized quantitative sensory tests the characteristic profile of sensory signs in each patient can be elucidated.

The DFNS has successfully developed and implemented a standardized and comprehensive protocol for quantitative sensory testing (Rolke et al., 2006). Till 2007 more than 1200 neuropathic pain patients have been tested with this QST battery. In order to have data for comparison QST reference values from about 180 healthy volunteers (male and female, two age ranges) from 10 participating centers have been obtained. The QST battery consists of 7 tests measuring 13 parameters and enables to obtain a full sensory profile for one body region in about 30 min.

In order to guarantee a comprehensive quality standard, a central Quality Management Center needs to be established. The tasks of this center in Mannheim/ Universität Heidelberg are:

• definition of certification criteria of the QST (Quantitative Sensory Testing) Laboratories
• superveillance of certification
• QST training for all national and international participating laboratories
• regular interlaboratory tests
• negotiations regarding invoice modalities for QST examinations with health insurance fund and DIMDI representatives

Organisation and coordination of clinical trials

In Kiel organisation and coordination of clinical trials will take place. Following the currently steadily rising demand for clinical studies from the industry (new products), an analysis and a selection of appropriate patients from the database will be created. Afterwards, the study protocols will be prepared and the performance of the studies will be coordinated by consistent communication with the other participating centers. Furthermore, the central data analysis including statistical analysis are covered by the Kiel group.

A maintaining of the functioning of the DFNS is needed to achieve a sustainable alliance. The performance of clinical trials provides the basis for the development of new drug treatment options and thus plays a central role in a research project that deals with neuropathic pain. The aim is to establish an individualized, mechanism-based therapy which will be especially advantageous looking at the aging population and the steadily rising costs in our health care system.