Yashchenko M.V. Formation of the clinical studies management system in contract research organizations under the influence of the regulatory system. – Qualifying scientific work, manuscript rights reserved.
Dissertation for obtaining the scientific degree of Doctor of Philosophy, branch of knowledge 07 «Management and administration» specialty 073 Management. – National University of Kyiv-Mohyla Academy, Kyiv, 2023.
This dissertation focuses on improving the management of clinical trials in contract research organizations in Ukraine, considering the impact of the regulatory system. It analyzes the regulatory practices of the USA and the EU, identifying unique aspects of managing clinical trials, especially in the context of COVID-19 and the military conflict with Russia. The author emphasizes the need to update the Ukrainian regulatory system for effective integration into the international market and to enhance the quality of healthcare.
The analysis of global regulatory trends revealed the need for reforms in contract research organizations to integrate the Ukrainian market of clinical trials into the global context. Key aspects include unifying regulatory procedures, eliminating legislative gaps, simplifying the process of obtaining permits, ensuring the accessibility of trial results, and creating open access databases. Also crucial is the development of infrastructure, including university clinics, and enhancing the efficiency of clinical trial management, which includes monitoring and developing the competencies of medical professionals, to attract investors and improve the clinical trial market in Ukraine.
The dissertation highlights the importance of quality and risk management in the context of clinical trials in Ukraine, considering contemporary challenges that may affect investor interest. It discusses modern quality management methods, such as CAPA-planning, and their application in the management of clinical trials. Particular attention is paid to reducing risks through data management and ensuring adherence to clinical trial protocols. The management model developed in the course of the dissertation research is aimed to improve the regulatory system of managing clinical trials in accordance with GxP and ISO requirements, enhancing efficiency in risk identification and management, as well as monitoring and controlling the performance of the risk management system.
Keywords: сlinical studies, clinical studies management, management model, risk management, regulation of clinical studies, regulatory mechanisms, regulatory system, good clinical practice, drugs, healthcare system, healthcare services, healthcare organizations, healthcare institutions, population health, qualitative research methods.
