OBJECTIVES

: The most important and definitely also the riskiest part of medical drug life cycle is the clinical trial which is conducted in human subjects. Pharmaceutical companies are obliged to adhere not only to Good Clinical Practice but also to many other country specific regulatory and legislative requirements. From the study center point of view, the conduction of the study brings a significant financial burden which is necessary to be compensated by the study sponsor and that is the reason why choosing the right financial strategy and budget planning is necessary for potential financial loss reduction.The main objective is to identify key aspects and potential risks of costs in providing clinical trials, focused on university hospital environment. Secondary objective is to assess and propose process of analyzing financial burden impact, related to practices at university hospitals and similar organisations.

METHODS

: Methodology consists of data collection from hospitals that is involved in providing clinical trials in Czech Republic. Collected data were analyzed and model of cost evaluation was compiled.

RESULTS

: Budget allocation of clinical trial has proved to be a comprehensive issues. Main areas of budget allocation were identified: personal costs, procedure costs, overhead costs, opportunity costs and patient compensations. The number of screening failure was revealed to be one of the most important parameters in analysis of budget impact. Screening Failure Rate affects dramatically whether overall costs will be covered or not.

CONCLUSIONS

: Payment strategy of screening failures is significantly variable, which means more complications for assessment of costs in clinical trial. The results can serve for further and deeper understanding of clinical trial site’s position, in relation to sponsor and patients both not only in Czech Republic but also worldwide.