[Drug research in Germany--problems and chances--from the viewpoint of the drug industry]. / Medizinische Forschung in Deutschland--Probleme und Chancen--aus Sicht der Pharmazeutischen Industrie.

A trend can be observed for multinational research-based drug companies shifting their resources away from Germany (and partly also from Europe) and expanding their preclinical and clinical drug research and development programmes and organizations in the USA. The main reasons, which are presently under discussion in Germany, are the image and public acceptance of clinical drug research, professionalism of clinical studies (i.e. availability of an adequate infrastructure), the process of ethics committees votes, the citation impact of publications, the legal obstacles, the implementation of Good Clinical Practice (GCP), the regulatory and institutional situation and the political environment. These problems have been recognised and appraised recently by the pharmaceutical industry, universities, scientific associations, and governmental institutions. Prerequisites to improve the basic conditions of clinical research in Germany to make it internationally competitive are proposed in this paper.

[Clinical drug trials in Germany--an assessment of current status from the viewpoint of industry]. / Klinische Arzneimittelforschung in Deutschland--Eine Standortbestimmung aus Sicht der Industrie.

Drug development today is a highly professional and costly affair, whereby quality and speed are decisive competitive factors in a global setting. Germany is in the process of losing its attractiveness for clinical drug research as evidenced by a significant decrease in funding of clinical drug research which at the moment amounts to about 1.5 billion DM/year. This decrease is due to an adverse environment created by a certain anxiety in public opinion regarding technological advances, an overburden of regulations, lack of an infrastructure in hospitals to work according to GCP and a regulatory agency which has to compete with momentarily more effective agencies in Europe (UK, France). A joint effort between industry and the medical profession is called for to change this situation for the better.