Randomization service for clinical trials

The term evidence-based medicine has become established in modern medicine. It implies that new treatments and therapies should only be used based on scientific knowledge (evidence). A distinction is made between different classes of evidence. The lowest class of evidence is a case series or a simple expert opinion without direct scientific evidence. The highest level of evidence is several controlled, randomized trials that all came to the same conclusion. Controlled in the context of studies means that you not only test the effect of a new therapy, but also compare it with a control group, for example a current standard therapy. Randomized in the context of studies means that the study participants are assigned to the treatment groups “randomly”. This is important to avoid a bias, e.g. of the study doctors. In this way, one could (unconsciously) assign healthier patients to the new and more ill to the old therapy. This would falsify the result of the study.

An in-house version of a randomization service is operated and further developed at the Institute of Medical Informatics. This supports the most common randomization algorithms, such as block randomization with different block sizes and the stratification according to any patient attributes, e.g. gender, age etc. A web interface for a direct connection to the hospital information system (HIS) Agfa ORBIS of the University Hospital Münster (UKM) has been implemented and enables randomization directly in routine documentation. A graphical user interface for a comfortable configuration of the studies, randomization of participants and monitoring is also offered.
The randomization service is developed in close cooperation with the Institute of Biostatistics and Clinical Research (IBKF) and the Centre for Clinical Trials Münster (ZKS Münster). Currently, the randomization service cannot be used for AMG or MPG studies, since its implementation has not yet been validated. If you are not sure, which requirements are placed on your study, please contact the IBKF for an advisory discussion.

Contact IBKF
Contact ZKS
Contact IMI: Dr. Tobias.Brix