Mission and tasks of the Coordination Centres for Clinical Trials

被引:5
作者
Luntz, S. P. [2 ]
Gorbauch, T. [1 ]
Schroeder, B. [2 ]
Seibert-Grafe, M. [1 ]
机构
[1] Johannes Gutenberg Univ Mainz, IZKS, D-55131 Mainz, Germany
[2] Univ Heidelberg, KKS, Heidelberg, Germany
关键词
Clinical research; Clinical trials; KKS; RCT; GCP;
D O I
10.1007/s00103-009-0820-x
中图分类号
R1 [预防医学、卫生学];
学科分类号
1004 ; 120402 ;
摘要
Coordination Centres for Clinical Trials (Koordinierungszentren fur Klinische Studien, KKS) were set up to increase the quality and number of clinical trials in Germany as well as to establish clinical trial training programs in order to improve international recognition of German clinical research. Over the past 6 years, 12 KKS have been set up at the respective universities with a public grant from the Federal Ministry of Education and Research (BMBF). Many non-clinical services have been established to ensure successful co-operation in clinical trials with clinical scientists and industry. KKS help researchers to efficiently conduct commercial and non-commercial clinical trials in various disease areas. Their expertise and infrastructure allow the university to assume sponsor responsibility in non-commercial drug trials. Because of their professional work and education activities KKS are well accepted by industry and the scientific community. Central professional trial organisations such as the KKS have been shown to be the pre-requisite for meeting the growing, manifold and complex requirements for clinical trials. Therefore they are considered essential for progress and success in clinical research.
引用
收藏
页码:444 / 450
页数:7
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