OBJECTIVES: Economic evaluation in clinical trials (CTs) is emerging actively as a valuable instrument of generating new knowledge and data-driven decisions within HTA process. Developing best practices for cost-effectiveness analysis (CEA) at the stage of clinical study is up-to-date which requires appropriate response and preparedness of the industry stakeholders. This study aims at defining the awareness about the key aspects of economic evaluation in CTs and perceptions of its barriers among specialists involved in clinical research.

METHODS: a qualitative survey with CT specialists of international contract research organisations, research departments of Ukrainian pharmaceutical companies, site management organisations, investigators at clinical trial sites and HTA experts.

RESULTS: 95% of respondents were aware of CTs with economic evaluation however only 7% have been involved in such studies. The key barriers for implementing CEA at the CTs are: lack of national guidelines (50%) and lack of methodological support (21.4%). 43% of respondents think that CEA will sophisticate clinical research protocol, particularly by increasing complexity of statistical analysis (28.6%) and the need to modify data collection instruments (21.4%). Overall, third of respondents consider CEA in CTs reasonable provided that this does not lead to significant complication of study protocol. At the same time, 57% acknowledge the practical significance of CTs with economic component as high (43%) and extremely high (14%). Also, respondents noticed the range of factors that might compromise validity of the cost-effectiveness data generated in a CTs: lack of standard operating procedures and unified guidelines on economic data collection (64.3%); poor transparency of CT results (21.4%) and low HTA implementation (7.1%).

CONCLUSIONS: The survey results revealed the key considerations important for promoting CT-based economic evaluation in Ukraine. A special attention should be paid to developing national guidelines which demand appropriate involvement of drug development and HTA stakeholders.