ARRANGING AND CONDUCTING VACCINE CLINICAL TRIALS FOR THE PURPOSE OF MARKETING AUTHORIZATION
The review highlights the issues relating to arranging and conducting vaccine clinical trials (CT) for the purpose of state marketing authorization namely: basic approaches to selection of volunteers for clinical trials, the steps in conducting CT depending on a phase of a trial; characteristics of basic phases of a trial, goals and objectives of each phase, design features of the vaccine CT. The process of arranging and conducting CT is guided by the requirements set out in the regulations, the references to which are given in the present review. Based on the analysis of vaccine CT as a part of expert evaluation of documents submitted for the state marketing authorization, the authors presented a list of typical mistakes when conducting the trials. The attention is being drawn to deficiencies that may lead to improper conclusions concerning the safety and the efficacy of the vaccine under research and cause the rejection of marketing authorization. The information provided in the present article will allow the researchers to plan and conduct high quality vaccine clinical trials.