DFG-Project Tr 471 /1-2:
Therapeutic Equivalence
Partner:
- Abt. Med. Informatik, Biometrie und Epidemiologie
Ruhr-Universität Bochum - Deutsche Forschungsgemeinschaft
Project Management:
- Prof. Dr. H-J. Trampisch, Bochum
- Dr. S. Lange, Bochum
- Prof. Dr. A. Munk, Göttingen
Staff:
- Gudrun Freitag
Description:
In recent years methods for detecting the therapeutic equivalence of medical treatment have gained greater importance in the clinical research. There are a few reasons for this change. In view of a constant progress in medicine it is more and more difficult to develop new treatment methods which promise a (clinically relevant) superiority over the already existing therapeutic methods. Furthermore, a greater stress has generally been laid on the therapeutic influence on early stages of the disease (keyword: "prevention") and thus less distinct therapy effects have to be taken into account. Conseqently, it is not more effective treatment methods that are being looked for but those which have as few side effects as possible in comparison to conventional therapies.
In spite of great socio-political importance of the therapeutic equivqlence studies, neither exact formulation of the problem nor a systematically elaborated methodology of statistical data analysis has been developed. The objective of the project may be divided into three parts. First, the medically relevant equivalence parameters and their determinants needed for determining of the appropriate equivalence limits are to be identified and classified.
Second, statistical methods of estimating and testing of the parameters are to be developed. Finally, we are to develop software which enables the implementation of sample size determination and evaluation of therapeutic equivalence examinations in clinical studies.
This is a project in cooperation with the Department for Medical Informatics, Biometrics and Epidemiology at the Ruhr-University of Bochum and is supported by the German Society for the Advancement of Scientific Research