Clinical trials, since they provide proof of the efficacy and the safety of newly developed therapeutic and diagnostic methods, are important means by which the results of basic research are transferred into routine clinical application. The new therapeutics are tested on a representative group of patients, the success of which is evaluated on the basis of biometric criteria.
Clinical trials can involve several thousand patients over a number of years. Therefore, high standards are required from the institutions that perform such trials. The IMISE offers, in close co-operation with the Coordination Center for Clinical Studies, Leipzig (KKSL), the planning, execution and evaluation of clinical trials. The Institute also offers study design, patient sample size calculation, randomisation, CRF development, data base construction, electronic data capture, telematics, data management and biometric evaluation. Currently, the IMISE is involved in the following major national trial groups:
- Non Hodgkin Lymphoma (NHL)
The German high grade malignant Non Hodgkin lymphomas (DSHNHL) study group performs clinical studies concerning this disease. In collaboration with the pharmaceutical company Hoffman-La Roche, it is also performing an international registration trial involving patients with agressive Diffuse Large B-cell Non Hodgkin lymphomas.
- Hereditary Tumor Diseases
IMISE provides the central data bases for the national cooperative trial groups on hereditary colo-rectal cancer and on hereditary breast and ovarian cancer. The goal is to conduct molecular-genetic tests as well as to develop new predictive and treatment concepts.
- Molecular Studies of Tumours
The IMISE provides the central data base for the national consortium "Molecular mechanisms of malignant lymphomas" and "Glioma” both funded by the "Deutsche Krebshilfe".
- Sepsis Competence Network
The Sepsis competence network aims to develop within Germany a cooperative study group, investigating Sepsis and performing large clinical and epidemiological trials.