Carreras Maria-Josep, Renedo-Miró Berta, Valdivia Carolina, Tomás-Guillén Elena, Farriols Anna, Mañós Laura, Vidal Jana, Alcalde María, De la Paz Isabel, Jiménez-Lozano Inés, Palacio-Lacambra Maria-Eugenia, Sabaté Nuria, Felip Enriqueta, Garralda Elena, Garau Margarita, Gorgas Maria-Queralt, Monterde Josep, Tabernero Josep
Pharmacy Department, Vall d'Hebron University Hospital, E-08035 Barcelona, Spain.
Asserta Global Healthcare Solutions, Sant Quirze del Vallés, E-08192 Barcelona, Spain.
Cancers (Basel). 2024 Apr 17;16(8):1529. doi: 10.3390/cancers16081529.
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.
这项单中心回顾性研究的目的是描述在10年期间（2010 - 2019年）参加癌症临床试验的成年实体瘤患者的临床特征，并评估与赞助商贡献相关的药物成本节约（DCA）。赞助商对药物支出的贡献是根据在没有赞助的情况下，比韦拉诺大学医院（HUVH）每年本应承担的药品实际价格计算得出的。共进行了2930项临床试验，有10488名参与者。2010年有140项试验，2019年有459项（增长228%）。高复杂性I期临床试验和篮子试验占所有试验的34.3%。在研究期间，临床研究模式有很大变化，2010年，靶向治疗占支出的79.4%，细胞毒性药物占20.6%；2019年，免疫治疗占68.4%，靶向治疗占24.4%，细胞毒性药物仅占7.1%。总共使用了421种不同的抗肿瘤药物，其种类从2010年的47种增加到2019年的317种，其中2010年只有7种占药品总支出的92.8%，2019年有33种占总支出的90.6%。未纳入临床试验的临床护理患者的抗肿瘤药物总支出为120396096欧元。赞助商在临床试验环境中提供的抗肿瘤药物总成本为107306084欧元，潜在的药物成本节约为92662609欧元。总体而言，临床试验不仅为临床研究和医疗保健的进展提供了最佳环境，还为降低癌症护理成本创造了机会。
