title: Efficacy and quality in clinical trials. Requirements to the investigator site. European Economic Community.
abstract: 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.
authors.affiliation: Universitäts-Kinderklinik Heidelberg, Fed. Rep. of Germany.
authors.forename: E
authors.initials: E
authors.lastname: Friederichs
authors.forename: S G
authors.initials: SG
authors.lastname: Spitzer
authors.forename: R
authors.initials: R
authors.lastname: Bach
mesh_terms: D002986:Clinical Trials as Topic / Q000191:economics / Q000592:standards*; D004345:Drug Industry; D005062:European Union; D006761:Hospitals; D006801:Humans; D008962:Models, Theoretical; D010361:Patients; D011786:Quality Control