The objective of this single-center retrospective study was to describe the clinical characteristics of adult patients with solid tumors enrolled in cancer clinical trials over a 10-year period (2010–2019) and to assess drug cost avoidance (DCA) associated with sponsors’ contributions. The sponsors’ contribution to pharmaceutical expenditure was calculated according to the actual price (for each year) of pharmaceutical specialties that the Vall d’Hebron University Hospital (HUVH) would have had to bear in the absence of sponsorship. A total of 2930 clinical trials were conducted with 10,488 participants. There were 140 trials in 2010 and 459 in 2019 (228% increase). Clinical trials of high complexity phase I and basket trials accounted for 34.3% of all trials. There has been a large variation in the pattern of clinical research over the study period, whereas, in 2010, targeted therapy accounted for 79.4% of expenditure and cytotoxic drugs for 20.6%; in 2019, immunotherapy accounted for 68.4%, targeted therapy for 24.4%, and cytotoxic drugs for only 7.1%. A total of four hundred twenty-one different antineoplastic agents were used, the variability of which increased from forty-seven agents in 2010, with only seven of them accounting for 92.8% of the overall pharmaceutical expenditure) to three hundred seventeen different antineoplastic agents in 2019, with thirty-three of them accounting for 90.6% of the overall expenditure. The overall expenditure on antineoplastic drugs in clinical care patients not included in clinical trials was EUR 120,396,096. The total cost of antineoplastic drugs supplied by sponsors in a clinical trial setting was EUR 107,306,084, with a potential DCA of EUR 92,662,609. Overall, clinical trials provide not only the best context for the progress of clinical research and healthcare but also create opportunities for reducing cancer care costs.
本研究为单中心回顾性分析，旨在描述2010年至2019年十年间参与肿瘤临床试验的实体瘤成年患者的临床特征，并评估申办方资助带来的药物费用节约效应。药物费用节约的计算基于巴塞罗那瓦尔德希伯伦大学医院在无申办方资助情况下需承担的专业药物实际年度价格。研究期间共开展2930项临床试验，纳入10488例受试者。2010年开展试验140项，2019年增至459项（增长228%）。高复杂性I期临床试验和篮子试验占比达34.3%。十年间临床研究模式呈现显著变化：2010年靶向治疗药物费用占比79.4%，细胞毒药物占20.6%；至2019年，免疫治疗药物占比升至68.4%，靶向治疗药物占24.4%，细胞毒药物仅占7.1%。共使用421种不同抗肿瘤药物，药物多样性从2010年的47种（其中7种药物占药物总费用的92.8%）显著增加至2019年的317种（其中33种药物占费用总额的90.6%）。非临床试验患者的抗肿瘤药物总支出为120,396,096欧元，而临床试验中申办方提供的抗肿瘤药物总价值达107,306,084欧元，潜在药物费用节约达92,662,609欧元。研究表明，临床试验不仅为临床研究和医疗进步提供最佳平台，同时也为降低肿瘤诊疗成本创造了重要机遇。
肿瘤(癌症)患者之家