Friederichs E, Spitzer S G, Bach R
Universitäts-Kinderklinik Heidelberg, Fed. Rep. of Germany.
Arzneimittelforschung. 1994 Feb;44(2):182-4.
Guidelines and recommendations to conduct clinical trials have been defined for Europe since 1st July 1991 to ensure high quality standards. Thus, cost and speed of clinical trials are becoming more and more important in clinical research. The article tries to summarize specific requirements to the investigator site considering the aspects of quality and data evaluation. Furtheron a model is proposed to optimize realization of clinical trials in hospital institutions. Realization of "Good Clinical practice" (GCP) at the sponsor and the investigator site will improve the quality of clinical trials for the sake of the patients and finally leads to the acceptance of European clinical trials abroad.
自1991年7月1日起，欧洲已制定了开展临床试验的指南和建议，以确保高标准的质量。因此，临床试验的成本和速度在临床研究中变得越来越重要。本文试图从质量和数据评估方面总结对研究机构的具体要求。此外，还提出了一个模型，以优化医院机构中临床试验的实施。申办方和研究机构实施“良好临床实践”（GCP）将为患者提高临床试验质量，并最终使欧洲的临床试验在国外获得认可。
