RESULTS OF THE ANALYSIS OF THE ESTABLISHED RESEARCH SYSTEM AND BARRIERS TO ITS DEVELOPMENT IN KAZAKHSTAN

Abstract

The advancement of clinical research is a key indicator of a well-developed healthcare system. It reflects the presence of a strong research foundation, skilled professionals, and infrastructure capable of supporting complex medical studies. Furthermore, it highlights effective regulation and ethical standards, which are crucial for ensuring high-quality healthcare services and fostering innovations in the field. Conducting clinical trials ensures early access for patients to advanced treatment methods. To create a sustainable system and a favorable environment for the development of clinical research, it is essential to adhere to several key components: legal regulations that meet international requirements, the presence of infrastructure at the research site, a high potential of researchers, established processes for interaction between stakeholders, openness of representatives at potential clinical research sites, accessibility of information on morbidity, and a single source of access to information about ongoing clinical trials for patients, volunteers, and their families. Aim: to assess the environment of Kazakhstan and the compliance of components for the implementation of clinical trials, to determine strategic directions for development. Materials and methods: the PESTEL analysis tool was used, which covered 6 areas of assessment: political, economic, social, technological, environmental, and legal factors. Results: The study revealed several problems, including incomplete harmonization of the regulatory framework with international requirements in clinical research, hesitancy and low readiness of medical organization managers to conduct clinical trials, inadequate research experience among doctors, absence of training programs for clinical research specialists, lack of mechanisms regulating life and health insurance for research subjects, complex interaction mechanisms between participants regulating and conducting clinical trials, absence of monitoring of clinical trial results implementation, lack of a unified system for registering clinical trials, clinical trial scope not aligned with healthcare needs, and absence of tools to inform interested population groups. Conclusions: The following specific strategic directions have been developed to promote the development of clinical research in Kazakhstan: creating a favorable regulatory environment to ensure the conduct of clinical research, strengthening infrastructure and consolidating functions, automating registration processes and conducting clinical trials, increasing the capacity of researchers, informing stakeholders, and fostering a culture of participation in clinical trials.