The Magdeburg Clinical Studies' Network for pediatric diseases.
New pharmaceutical technologies had created either enthusiastic hope for major improvements in the medical treatment or major doubts on the use of research data and wrongdoing in clinical trials. Clinical investigators have to consider methodological and scientific principles, to stick to ethical rules, national law and international guidelines. With the invention of General Clinical Research Centres the necessary infrastructure in hospitals with well-trained personnel and the availability of laboratory, clinical and supporting service has been created in the US. Taking GCRC as a model to improve the clinical research in pediatrics, a formal collaboration between the Department of Pediatrics and the Institute for Biometry and Medical Informatics was established at the Otto-von-Guericke-University Magdeburg in 2001. Both nation-wide quality assurance programmes in Pediatric Endocrinology and clinical trials according to the principles of good clinical practice ('GCP') were planned and currently performed. Thus with the resources of the Medical faculty and additional project bound finances the necessary infrastructure has been developed.
Mohnike
Klaus
K
Dept. of Pediatrics, Medical Faculty, Otto-von-Guericke-University, Wiener Strasse, 39112 Magdeburg, Germany. klaus.mohnike@medizin.uni-magdeburg.de
Empting
Susann
S
Roehl
Friedrich-Wilhelm
FW
D002986:Clinical Trials as Topic; D005858:Germany; D006801:Humans; D010372:Pediatrics; D011785:Quality Assurance, Health Care