Aspects of the implementation of economic models for health technology assessment in clinical trials of medicines

Abstract

The aim of the work is to scientifically substantiate the basic aspects of developing a methodology for including сost-effectiveness analysis in key processes of clinical trials of medicines. Results. It is established that Ukrainian regulatory system and methodological support of clinical trials with included сost-effectiveness analysis is based on separate regulations in the field of clinical trial and health technology assessment. At the same time, there is no methodological support for the management of сost-effectiveness analysis alongside clinical trials, which would take into account the peculiarities of planning, organizing and conducting such studies. The algorithm of substantiation, development and inclusion of basic components of the analysis of economic effectiveness in the basic processes of planning and the organization of clinical trial of medicines is offered. Emphasis is placed on the need for a proper strategy for analyzing the economic efficiency of the studied medical technologies in clinical trials. The importance of proper selection of economic evaluation models (cost minimization, cost-effectiveness, cost-benefit) in accordance with the purpose of the clinical trial, the primary hypothesis and the selected primary and secondary endpoints is determined. Conclusions. It is determined that there are certain problems of methodological and organizational nature for the development of clinical trials with included сost-effectiveness analysis and economic endpoints. The solution of these tasks should begin at the planning stage of the study by implementing the basic step-by-step recommendations. Innovative treatment technologies that have potential health benefits are often investigated in clinical trials. Thus, the introduction of pharmacoeconomic analysis methods into the structure of traditional clinical trials is an additional important tool to ensure the effective functioning and development of health technology assessment. In further research it is planned to develop scientific and practical approaches to ensure the proper implementation of management processes of сost-effectiveness analysis alongside clinical trial and analysis of data on their results. Keywords: clinical trials; health technology assessment; algorithms; economic models; procedures