Abstract
AimThe aim of the present study was to assess the estimated “per patient” total cost for a single Oncologic Italian Cancer Center participating in a multicenter clinical trial with new anticancer biological agents using the activity-based costing (ABC) methodology.MethodologyNine randomized phase 3 clinical trials employing biological agents at the National Cancer Institute of Napoli, Italy, were analyzed to indentify “per patient” costs of each trial, according to the ABC methodology. The average consumption of resources for a patient completing the entire planned treatment was estimated for each trial. Through interviews of the personnel (doctors, nurses and technicians) and by analyses of the clinical trials protocols, the main activities of the 9 clinical trials were identified and, for each trial, the complete health care pathway of the patients and the treatment programmes were minutely reconstructed. Drug costs were not included because provided by Sponsors.Principal findingsThe average costs of the pre-study, treatment, monitoring, follow-up, audit, and administrative activities accounted for 2.357, 4.783, 700, 372, 1.263, and 9 Euro, respectively. The average total cost estimated for all “per patient” activities, including overhead costs, was 11.379 Euro. Staff costs accounted for € 5.988, while costs of diagnostic test accounted for 3.494 Euro. Clinical trials with immunotherapeutic drugs accounted for higher costs (+601 Euro as oncological staff costs, +1.318 Euro as intermediate services cost and +384 Euro as overheads).ConclusionsThe average total cost estimated for all “per patient” activities of a clinical trial with new anticancer biological agents was 11.379 Euro using the ABC methodology.
Highlights
Clinical research plays a critical role for drugs development
Revenues are quite easy to measure, as they are related to the activities specified in the clinical trial protocol, but the same cannot be said for costs
According to the traditional managerial accounting systems based on cost centers, the costs typically related to the activities of clinical trials are mostly indirect, as it is not possible to assess the amount of any specific resource used for each trial through objective measure
Summary
Clinical research plays a critical role for drugs development. cost of clinical trials for a participating clinical centre is currently unknown and difficult to determine [1]. According to the traditional managerial accounting systems based on cost centers, the costs typically related to the activities of clinical trials are mostly indirect (staff costs, diagnostic test costs, medical instruments maintenance and depreciation costs, etc), as it is not possible to assess the amount of any specific resource used for each trial through objective measure. All production costs are charged directly to the center where the consumption of the resources takes place and only indirectly to the patients receiving the treatment. In this context, the activity-based costing (ABC) methodology can be used to overcome the shortfalls of the traditional cost accounting systems, especially when indirect costs, not directly traceable to the products-services, represent an important proportion of the total cost [2]. ABC allows to determine the standard full cost per service unit provided by the hospital (for instance, the unit patient cost), as a tool for administrative cost information, strategic decision-making, quality and efficiency improvement [3]
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