Study of the Domestic Experience of Implementing the Impact of the Regulatory System on the Clinical Trials Management

Abstract

The article deals with the general analysis of the domestic experience of implementing the impact of the regulatory system on the clinical examinations management. It has been determined that in all the developed countries the state continues playing the key role in regulating the sphere of scientific investigations and innovations, in particular, the pharmaceutical field. Despite the current normative and legal regulation, during inspections of the activities of enterprises conducting clinical examinations of medicines within the framework of state control, specialists of control and supervisory structures identify cases of non-compliance with mandatory requirements. It has been stated that nowadays conducting the clinical examinations is related to a number of risks: a significant pressure on the pharmaceutical companies in the aspect of quick development of new effective medicines with a low price; a huge number of standards and requirements that need to be met; increasing the complexity of clinical research (increase in the number of endpoints during the last 10 years, increase in the number of adaptive examinations), etc. It has been resumed that the development of additional tools to improve the quality of the informed consent procedure as the main stage of informing subjects about the benefits of participation, limitations on the time of the clinical examinations, risks that may arise from participation, etc., is currently relevant. Analysis of the influence of regulatory system of Ukraine on the problem of clinical examinations management gave an opportunity to assume that the list of potentially viable variants for solving the outlined issue through the implementation of state policy include: increasing the attractiveness of the clinical examinations market of Ukraine for domestic and foreign investors; creating the conditions for infrastructure formation and development in Ukraine, which is necessary for conducting modern biomedical studies; implementing the effective mechanisms of involving doctors to the clinical examinations, etc. It has been generalized that state regulation in the field of conducting clinical examinations is continuously modified and has a tendency to develop a stable legal base and comprehensive harmonization of the Ukrainian legislation with international requirements of basic principles regarding clinical examinations based on the achievements of modern science and new medical technologies.