Development of the Methodology and Volume of the Program of the Approbation of Clinical Interventions in Federal Research Centers

This thesis is aimed at the research of the program of the approbation of clinical interventions and the evaluation of its results from 2015 to 2020. Methodology and regulatory framework and its evolution was analyzed. Key quality characteristics of protocols of the approbation of clinical interventions were revealed, presented; comparative analysis of clinical approbation protocol and clinical trial protocol (according to Good Clinical Practice) was performed. The algorithm of the clinical and economic efficiency of evaluating the intervention within the approbation was analyzed. Key quantity characteristics of protocols of the approbation of clinical interventions were revealed and presented for evaluating the volume of the program of clinical approbation and evaluation its impact to state guarantee program dynamics. Guidelines to design of protocol of the approbation of clinical interventions and regulatory framework modification related to the program were developed. Key words: program of the approbation of clinical interventions; clinical approbation