The Centre for Clinical Trials Lübeck (ZKS Lübeck)

The Centre for Clinical Trials at the University of Lübeck provides comprehensive consultancy and support in the design, implementation and evaluation of clinical research projects.

Since its foundation in 2009, the ZKS Lübeck has been in operation without any public funding. The efficiency of the Centre for Clinical Trials is based upon the commitment of its qualified members of staff and its close cooperation with the Institute for Medical Biometry and Statistics (IMBS, Director: Professor Andreas Ziegler, Sc.D.). As a result, the ZKS Lübeck is able to offer an efficient infrastructure for the implementation of clinical trials from the first draft through to concept development, the preparation of trial processes in the respective trial centres, staff training courses, on-site monitoring, to statistical-methodological processing and publication. In cooperation with the IMBS, the ZKS Lübeck also offers a comprehensive range of services in the field of pharmacogenetics and in the development and testing of biomarkers. The ZKS Lübeck provides a broad spectrum of scientific services to scientists in universities, clinics and the industrial sector, both at regional and at supra-regional level.

Objectives of the ZKS Lübeck

Clinical trials are medical-scientific research projects, and their design, implementation and evaluation need to comply with international quality standards. Many therapeutic, diagnostic, prognostic, health-economic and other application-oriented clinical-scientific issues can only be addressed by large multi-centre clinical trials, which poses additional challenges with regard to organisation and communication skills.

The ZKS Lübeck was established to further improve the prerequisites for the implementation of and the participation in clinical trials according to internationally recognised quality standards. As a scientific facility of the University Lübeck, the ZKS is responsible for scientific and organisational tasks in patient-oriented clinical research.

Cooperation across borders

As part of an EU-funding programme for stimulating cooperations in public health between different European regions (INTERREG-IV programme), the ZKS Lübeck is a cooperation partner of the German project partner, the Department of Radiotherapy of the University Medical Centre Schleswig-Holstein (UKSH) based at the campus in Lübeck. The Danish Partner of the Department of Radiotherapy is the Department of Oncology at the Naestved Hospital in the Danish region of Sjaelland. Objective of the funding programme is the establishment of a trial centre, the development of joint clinical study protocols and the exchange of expertise between the oncology related occupational classes working at the two sites. 

Qualification

The ZKS Lübeck offers a wide range of training programmes for physicians, scientists and medical personnel involved in clinical research. These programmes convey profound knowledge on current regulatory requirements and the ethical framework of clinical research as well as on the design, implementation and management of clinical trials. So far, more than 200 participants from all over Germany have successfully concluded the courses for investigators and for directors of clinical investigations (in Germany only) offered by the ZKS Lübeck in accordance with the curricula developed by the KKS Network. For the future, further courses are planned in order to meet the quality requirements in clinical research in the long term.