One significant prerequisite for the implementation of high-quality studies in the network is the establishment of a uniform, standardized process quality for project planning, implementation and analysis for all partners as well as for documentation and material flow. Beyond that there is a great need to make information and data available to all partners in an efficient, timely manner. At the same time, electronic storage and transmission of medical data requires great care with regard to data protection and privacy. As an instrument of communication, procurement and increasingly for the publication of specialist information, the Internet has become the most important medium.
With the development of the Center for Study Coordination, Study Management and Biometry (CSSB), structures for the implementation of large-scale, internationally competitive scientific studies are now available to the Competence Network Heart Failure (CNHF). The studies are carried out with uniform quality standards at all participating partner institutes and meet the highest biometric, documentary and data protection criteria. The central database structures must be continuously maintained, evaluated and expanded. New requirements for secure data exchange necessitate ongoing evaluation and adaptation of the implemented concepts.
With the Center for Study Coordination, Study Management and Biometry (CSSB) an efficient and supporting facility was built up to conduct and analyse clinical trials. In agreement with all subprojects of the CNHF a standardised basic clinical data set was defined. This data set is available for about 10.000 patients and makes cross-trial analyses possible.
We successfully supported several clinical trials (Aldo-DHF, MOOD-HF, Ex-DHF) to receive funding and provide ongoing support. Our assistance to all co-operating partners of the CNHF involves the development of suitable concepts and application of external funding as well as conduct, analysis and publication of non-commercial clinical trials.
Dr. Christiane Prettin
Zentrum für klinische Studien Leipzig – KKS, Universität Leipzig
Tel.: +49 (0)341 9716273