[The management in clinical trials of pharmacological agents].
The author analyzes the experience gained by foreign countries in the creation of a new management system in all spheres of public health, including clinical trials and use of drugs. A term "High-Quality Clinical Practice" is used in the European Community, reflecting the standard or the norm of clinical studies and designed as a complex of regulations for the organization and implementation of clinical studies. High-Quality Clinical Practice implies all reasonable measures providing the accuracy of experimental data and guarantees the rights of the participants in the trials. Studies carried out in conformity with the requirements of High-Quality Clinical Practice bring about reliable results and permit the pharmaceutical companies and public health organs use these data.
Kurmanova
L V
LV
Moskovskaya meditsinskaya akademiya im. I.M. Sechenova.
D002986:Clinical Trials as Topic; D006801:Humans; D004364:Pharmaceutical Preparations; D011786:Quality Control; D012106:Research / Q000458:organization & administration / Q000592:standards*
D004364:Pharmaceutical Preparations