Scientific Directorate, Istituto Nazionale Tumori "Fondazione G. Pascale", IRCCS, Napoli, Italy.
Dipartimento di Diritto, Economia, Management e Metodi Quantitativi, Università degli Studi del Sannio, Benevento, Italy.
PLoS One. 2019 Jan 8;14(1):e0210330. doi: 10.1371/journal.pone.0210330. eCollection 2019.
The 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.
Nine 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.
The 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).
The 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.
本研究旨在评估意大利某肿瘤中心参与多中心临床试验的单个患者的总费用，该试验使用新的抗癌生物制剂，采用作业成本法（ABC）进行评估。
分析意大利那不勒斯国家癌症研究所开展的 9 项使用生物制剂的随机 3 期临床试验，根据 ABC 方法确定每个试验的“每个患者”成本。为每个试验估算完成整个计划治疗的患者的平均资源消耗。通过对人员（医生、护士和技术人员）进行访谈，并对临床试验方案进行分析，确定了 9 项临床试验的主要活动，并详细重建了每位患者的完整医疗路径和治疗方案。由于药物由赞助商提供，因此未计入药物成本。
研究前、治疗、监测、随访、审核和行政活动的平均成本分别为 2.357、4.783、700、372、1.263 和 9 欧元。所有“每个患者”活动（包括间接费用）的平均总成本估计为 11.379 欧元。员工成本为€5.988，而诊断测试成本为 3.494 欧元。免疫治疗药物临床试验的成本更高（肿瘤学员工成本增加 601 欧元，中间服务成本增加 1.318 欧元，间接费用增加 384 欧元）。
采用 ABC 方法，评估新抗癌生物制剂临床试验的所有“每个患者”活动的平均总成本为 11.379 欧元。
