The Münchner Studienzentrum (MSZ)
As a central coordinating study office, the Münchner Studienzentrum (Munich Trial Centre) is responsible for integrating the Munich area into the nationwide network of clinical research. The MSZ was established as an independent institution in 2002 and has been a member of the KKS Network since 2007.
The MSZ is a facility of the Medical Faculty of the ‘Klinikum rechts der Isar’ of the Technical University of Munich.
The MSZ is one of the trial centres funded by the German Federal Ministry of Education and Research as part of the funding programme ‘Clinical Trial Centres’ in 2007. After a successful interim evaluation, the MSZ is being funded for a second funding period until 2015. At present, the MSZ has 30 members of staff, who support clinicians and industrial partners in the design, implementation and evaluation of clinical trials. The MSZ is headed by Christine Blankenstein, MD. The MSZ and the departments involved in clinical research are supported by a steering committee headed by the Dean of the Medical Faculty.
Central coordinating study office for the Munich area
As a central coordinating study office, the MSZ aims at increasing the number of study patients in the Munich area. At present, the MSZ supports commercial clinical research projects as well as investigator-initiated trials, for which it takes responsibility as delegated from the sponsor. The MSZ is also involved in investigator-initiated trials conducted by other universities and study groups.
The MSZ is mainly responsible for clinical trials in haematology and oncology (60%); other medical specialities are surgery, gastroenterology, gynaecology, urology and psychiatry. The MSZ also continuously cooperates with various hospitals and private practices in the Munich area.
Committed to study groups and training programmes
The MSZ regularly organises training programmes for investigators and clinical research personnel, for example, basic and advanced workshops on various subjects, such as the preparation of study protocols or audits and inspections, a 3-week training course for study assistants and courses for principal investigators according to the German Medicinal Products Act and the German Medical Devices Act.
Rotation of principal investigators
In 2008, the MSZ created rotating positions for resident doctors of most departments, who work as investigators in the design and implementation of clinical research projects for one year of their clinical training. This rotation supports the local research infrastructure and intensifies the know-how of clinical research personnel in departments involved in clinical research.
Cooperation with the IMSE
The MSZ benefits from its close connection with the Institute for Medical Statistics and Epidemiology (IMSE) of the Technical University of Munich. This institute is mainly focused on Medical Informatics and Biometry and headed by Professor Klaus A Kuhn, who is a cooperation partner of the MSZ within the context of the funding programme by the German Federal Ministry of Education and Research. Because the institute provides methodological study support with regard to biometry and informatics as well as the necessary IT infrastructure, the cooperation with the IMSE allows the MSZ to offer the entire range of study-specific services.