Scientific Directorate, Istituto Nazionale Tumori "Fondazione G. Pascale", IRCCS, Naples, Italy.
School of Banking Wyższa Szkoła Bankowa, WSB University in Wrocław, Wrocław, Poland.
BMC Health Serv Res. 2020 Nov 26;20(1):1089. doi: 10.1186/s12913-020-05928-6.
The cost of anticancer drugs is constantly growing. The aim of this study was determine the impact in terms of cost reduction for anticancer drug in the Italian Health Service due to patient participation in clinical trials.
We evaluated the cost of drugs administered to patients treated in clinical trials at the National Cancer Institute of Naples in a four-week time period. Patients with a diagnosis of different cancers were considered, including adjuvant therapy and treatment for advanced disease, pharma sponsored and investigator initiated phase I, II and III clinical studies. We defined the expected standard treatment for each patient and we calculated the cost of the standard antineoplastic drugs that should be administered in clinical practice outside clinical trials. We used the market price of drugs to determine the cost savings value. Costs other than drugs were not included in the cost saving calculation.
From 23.10.2017 to 17.11.2017, 126 patients were treated in 34 pharma sponsored and investigator initiated clinical trials, using experimental drugs provided free of charge by the sponsors, for an overall number of 152 cycles of therapy. If these patients were treated with conventional therapies in clinical practice the cost of antineoplastic drugs would account for 517,658 Euros, with an average of 5487 Euros saved per patients for a period of 4 weeks.
Clinical trials with investigational antineoplastic drugs provided free of charge by Sponsors render considerable cost savings, with a tangible benefit in clinical and administrative strategies to reduce drug expenditures.
抗癌药物的成本不断增长。本研究旨在确定由于患者参与临床试验，意大利卫生服务系统中抗癌药物的成本降低情况。
我们评估了在那不勒斯国家癌症研究所进行的为期四周的临床试验中接受治疗的患者的药物成本。考虑了不同癌症的患者，包括辅助治疗和晚期疾病的治疗、制药赞助商赞助和研究者发起的 I 期、II 期和 III 期临床试验。我们为每位患者定义了预期的标准治疗，并计算了应在临床试验之外的临床实践中给予标准抗肿瘤药物的成本。我们使用药物的市场价格来确定成本节约价值。成本节约计算中不包括除药物以外的成本。
2017 年 10 月 23 日至 11 月 17 日，34 项制药赞助商赞助和研究者发起的临床试验共治疗了 126 名患者，使用赞助商免费提供的实验药物，共进行了 152 个疗程的治疗。如果这些患者在临床实践中接受常规治疗，抗肿瘤药物的费用将达到 517658 欧元，每个患者在四周内平均节省 5487 欧元。
赞助商免费提供的研究性抗肿瘤药物的临床试验可节省大量成本，在降低药物支出的临床和管理策略方面具有切实的益处。
