[Development of highly specialized clinical drug trial units within health care institutions].
The purpose of the most of clinical trials conducted under the auspices of pharmaceutical industries is to evaluate the safety and efficacy of drugs, and they are conducted at university health care institutions or appropriate clinical centres. Close collaboration among the investigators, potential investigators and other academic citizens is essential for an effective and efficient conduct of these studies. Clinical studies usually test a drug which is to be instituted for the first time; therefore more attention is being dedicated to its administration, with monitoring of a greater number of valid parameters in accordance with the Good Clinical Practices (GCP) and Good Laboratory Practices (GLP) standards. These are very strict standards, which have been internationally adopted and are valid worldwide. They define the documentation required, the setting method, the necessary equipment and the facilities within which the clinical trials are to be conducted, as well as human resources indispensable for carrying out the clinical trials. The objective of this paper was to determine whether our medical instructions fulfil the necessary conditions for establishing the clinical trials units. Creation of a symbiosis of this kind (between the pharmaceutical industry and the appropriate health care institutions), reflected in the clinical trials unit, should enable the drug research and development to remain within our country.
Stanimirović
V
V
Galenika a.d.-Institute, Belgrade.
Babić
M
M
Nikolić
D
D
Cucak
S
S
Nikolić
A
A
D002986:Clinical Trials as Topic / Q000592:standards*; D004345:Drug Industry; D006268:Health Facilities / Q000592:standards; D006801:Humans; D007400:Interprofessional Relations