Starchenko M. Scientific-methodical approaches to organization and conducting of clinical trials with participation of healthy volunteers

The Candidate study is dedicated to feasibility and resolving of scientific problem that involves the elaboration of scientific-methodological approaches to organization and conducting of clinical trials with participation of healthy volunteers. The complex scientific research of organization-and-economic aspects of specific clinical trials - clinical trials with participation of healthy volunteers was conducted. The function of clinical trials within the evidentiary medicine and evidentiary pharmacy was defined; the conceptual framework of generic medicines research was developed and justified; general structure of clinical trials with the participation of healthy volunteers was defined. The scientific-methodological approach to organizational and finance-economic aspects of clinical trials with the participation of healthy volunteers was developed: the framework of complex evaluation of clinical trials with the participation of healthy volunteers, complex compensation model for healthy volunteers and its calculation methodology. The conceptual framework of clinical pharmacist activity in the clinical trials of medicines and professional competention of monitor area was developed. The training program for clinical pharmacists and qualified specialists in clinical trails was developed and implemented.