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癌症赞助临床试验对哥伦比亚医疗保健系统的经济效益:一种基于真实世界证据的方法。

Economic Benefits of Sponsored Clinical Trials in Cancer for the Colombian Healthcare System: A Real-World Evidence Approach.

作者信息

Rojas Leonardo, Sánchez Natalia, Ceballos Jorge, Robles Antonio, Badillo Carlos A, Abello Virginia, Bonilla Carlos, Mantilla William A, Zuluaga Jairo, Lopes Gilberto, Arrieta Oscar, Cardona Andrés F

机构信息

Luis Carlos Sarmiento Angulo Cancer Treatment and Research Center (CTIC), Bogotá, Colombia.

GIGA/TERA Research Group, Luis Carlos Sarmiento Angulo Cancer Treatment and Research Center (CTIC)/El Bosque University, Bogotá, Colombia.

出版信息

Cancer Med. 2025 Aug;14(15):e71099. doi: 10.1002/cam4.71099.

Abstract

PURPOSE

Clinical trials (CTs) are essential for the research and development of new cancer treatment technologies. Evaluating their economic impact and the potential cost savings for healthcare systems in low- and middle-income countries is crucial for informing healthcare policy and decision-making. This study estimates the economic benefits to the Colombian healthcare system from the inclusion of hematology and oncology patients in sponsored CTs.

METHODS

This study utilized real-world data from the Luis Carlos Sarmiento Angulo Cancer Treatment and Research Centre (CTIC), a comprehensive cancer center in Bogotá, Colombia. Tumor types were selected based on their prevalence and economic burden. A Budget Impact Analysis was conducted following the methodology of the local Health Technology Assessment Agency, using data from five prioritized tumor types. Clinical data and associated costs were extracted from the institutional data lake, and cost-generating events for each disease were validated by CTIC clinical experts. The estimated eligible population for phase 3 CTs was derived from literature reviews and expert opinions from CTIC clinicians. Prevalent and incident population data were obtained from the Colombian High-Cost Account.

RESULTS

A total of 7703 potential patients were eligible for inclusion in the CTs, with an associated healthcare cost of USD 244,151,552 by 2023 (1 USD = 4325 COP). If at least 20% of these patients participated in CTs by 2023, the projected annual cost savings would be USD 48,830,310. Among the evaluated cancers, advanced prostate cancer incurred the highest costs due to its high prevalence and potential for inclusion in CTs.

CONCLUSION

Over 5 years, potential cost savings could range from USD 244 million (assuming a 20% enrolment rate) to 1.22 billion (with 100% enrolment), alleviating financial pressures on the Colombian healthcare system. These savings would contribute to the system's long-term financial sustainability while ensuring timely access to innovative cancer treatments.

摘要

目的

临床试验对于新型癌症治疗技术的研发至关重要。评估其经济影响以及为低收入和中等收入国家医疗系统带来的潜在成本节约,对于为医疗政策和决策提供信息至关重要。本研究估计了将血液学和肿瘤学患者纳入赞助的临床试验给哥伦比亚医疗系统带来的经济效益。

方法

本研究利用了来自哥伦比亚波哥大的一家综合性癌症中心——路易斯·卡洛斯·萨米恩托·安古洛癌症治疗与研究中心(CTIC)的真实世界数据。根据肿瘤类型的患病率和经济负担进行选择。按照当地卫生技术评估机构的方法进行预算影响分析,使用来自五种优先肿瘤类型的数据。临床数据和相关成本从机构数据湖中提取,每种疾病的成本产生事件由CTIC临床专家进行验证。三期临床试验的估计合格人群来自文献综述和CTIC临床医生的专家意见。流行和发病的人群数据从哥伦比亚高成本账户获取。

结果

共有7703名潜在患者符合纳入临床试验的条件,到2023年相关医疗费用为244151552美元(1美元 = 4325哥伦比亚比索)。如果到2023年这些患者中至少20%参加临床试验,预计每年可节省成本48830310美元。在所评估的癌症中,晚期前列腺癌由于患病率高且有可能纳入临床试验,产生的成本最高。

结论

在5年时间里,潜在成本节约可能在2.44亿美元(假设参与率为20%)到12.2亿美元(参与率为100%)之间,减轻了哥伦比亚医疗系统的财务压力。这些节约将有助于该系统的长期财务可持续性,同时确保及时获得创新的癌症治疗方法。

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