Clinical drug research in Germany - Problems and chances - from the pharmaceutical industry's point of view

被引:0
|
作者
Weihrauch, TR
Baumbauer, E
机构
[1] Bayer AG, Leiter Med Int, Pharma Forschungszentrum, D-42096 Wuppertal, Germany
[2] Verband Forschender Arzneimittelhersteller EV, Forsch & Entwicklung, Bonn, Germany
来源
ARZNEIMITTEL-FORSCHUNG-DRUG RESEARCH | 1998年 / 48卷 / 11期
关键词
clinical drug research; ethics committees; Germany; Good Clinical Practice; multinational trials; pharmaceutical industry;
D O I
暂无
中图分类号
R914 [药物化学];
学科分类号
100701 ;
摘要
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.
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页码:1047 / 1050
页数:4
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