GBG Forschungs GmbH
GBG Forschungs GmbH, founded in 2003 by Prof. Dr. med. Gunter von Minckwitz, serves as the legal and operative platform for trials conducted by the German Breast Group, which is Germany’s largest breast cancer study group.
Professional structures for efficient research
Modern clinical research not only calls for a professional infrastructure, but also a suitable legal entity if it is to comply with the complex statutory requirements. GBG Forschungs GmbH has successfully established the necessary structures and processes and has thus been able to achieve a tenfold increase in the number of new patients recruited to the trials every year.
Scientific independence – a guiding principle
We consider ourselves to be independent, academically orientated and unbiased. Investigator-initiated trials, based on the practical experience of physicians with an active interest in scientific research, form the main focus of our research. Through our work, we aim to continually improve the treatment of breast cancer and the quality of the therapy available on a global basis. Unlike in the case of industry-initiated trials, drug approval considerations are only attributed secondary importance in our study concepts. Being an academic research organisation (ARO), GBG Forschungs GmbH does not carry out research purely on a contract basis as in the case of contract research organisations (ARO). All study projects have to address an academic research question which meets the requirements of the study group.
Charitable foundations and public bodies – our main sources of funding
We generally finance our research projects in advance by selling the subsequent usage rights to the study results. Translational research projects using biomaterial samples collected within the context of the trials are predominantly funded by charitable foundations and public bodies. When compiling, evaluating and publishing our trial protocols and databases, we adhere to the principles of international academic study groups. The procedures involved at every stage are carried out by our research institute and the German Breast Group’s sub-boards – on an independent basis, without any direct influence from the pharmaceutical industry.
The tasks undertaken by GBG Forschungs GmbH within the context of clinical trials are as follows:
- Concept and trial design
- Clinical project management
- Clinical monitoring
- Data management
- Biometrics and statistics
- External documentation
- Translational research
- Central pathology lab
- Advanced medical training
- Medical writing
- PR work
- Sponsoring
- Event management
