Weihrauch T R, Baumbauer E
Medizin International, Bayer AG, Pharmazeutisches Forschungszentrum, Wuppertal.
Arzneimittelforschung. 1998 Nov;48(11):1047-50.
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.
可以观察到一种趋势，即跨国研发型制药公司正将资源从德国（部分也从欧洲）转移出去，并在美国扩大其临床前和临床药物研发项目及机构。目前在德国正在讨论的主要原因包括临床药物研究的形象和公众接受度、临床研究的专业性（即是否具备充足的基础设施）、伦理委员会投票程序、出版物的引用影响力、法律障碍、良好临床实践（GCP）的实施情况、监管和机构状况以及政治环境。制药行业、大学、科学协会和政府机构最近已经认识到并评估了这些问题。本文提出了改善德国临床研究基础条件以使其具有国际竞争力的先决条件。
