Bennett C L, Stinson T J, Vogel V, Robertson L, Leedy D, O'Brien P, Hobbs J, Sutton T, Ruckdeschel J C, Chirikos T N, Weiner R S, Ramsey M M, Wicha M S
Robert H. Lurie Comprehensive Cancer Center, the Division of Hematology/Oncology, Chicago, Illinois, USA.
J Clin Oncol. 2000 Aug;18(15):2805-10. doi: 10.1200/JCO.2000.18.15.2805.
Medical care for clinical trials is often not reimbursed by insurers, primarily because of concern that medical care as part of clinical trials is expensive and not part of standard medical practice. In June 2000, President Clinton ordered Medicare to reimburse for medical care expenses incurred as part of cancer clinical trials, although many private insurers are concerned about the expense of this effort. To inform this policy debate, the costs and charges of care for patients on clinical trials are being evaluated. In this Association of American Cancer Institutes (AACI) Clinical Trials Costs and Charges pilot study, we describe the results and operational considerations of one of the first completed multisite economic analyses of clinical trials.
Our pilot effort included assessment of total direct medical charges for 6 months of care for 35 case patients who received care on phase II clinical trials and for 35 matched controls (based on age, sex, disease, stage, and treatment period) at five AACI member cancer centers. Charge data were obtained for hospital and ancillary services from automated claims files at individual study institutions. The analyses were based on the perspective of a third-party payer.
The mean age of the phase II clinical trial patients was 58.3 years versus 57.3 years for control patients. The study population included persons with cancer of the breast (n = 24), lung (n = 18), colon (n = 16), prostate (n = 4), and lymphoma (n = 8). The ratio of male-to-female patients was 3:4, with greater than 75% of patients having stage III to IV disease. Total mean charges for treatment from the time of study enrollment through 6 months were similar: $57,542 for clinical trial patients and $63,721 for control patients (1998 US$; P =.4)
Multisite economic analyses of oncology clinical trials are in progress. Strategies that are not likely to overburden data managers and clinicians are possible to devise. However, these studies require careful planning and coordination among cancer center directors, finance department personnel, economists, and health services researchers.
临床试验的医疗护理费用通常无法从保险公司获得报销，主要原因是担心作为临床试验一部分的医疗护理费用高昂且不属于标准医疗实践范畴。2000年6月，克林顿总统下令医疗保险为癌症临床试验中产生的医疗护理费用提供报销，尽管许多私人保险公司对这项举措的费用有所担忧。为了为这场政策辩论提供信息依据，正在对临床试验患者的护理成本和收费情况进行评估。在美国癌症研究所协会（AACI）的临床试验成本与收费试点研究中，我们描述了首批完成的多中心临床试验经济分析之一的结果及操作考量因素。
我们的试点工作包括评估35例在II期临床试验中接受护理的病例患者以及在五个AACI成员癌症中心的35名匹配对照患者（基于年龄、性别、疾病、阶段和治疗时期）6个月护理的总直接医疗费用。从各个研究机构的自动化理赔文件中获取医院和辅助服务的收费数据。分析是基于第三方付款人的视角。
II期临床试验患者的平均年龄为58.3岁，对照患者为57.3岁。研究人群包括乳腺癌患者（n = 24）、肺癌患者（n = 18）、结肠癌患者（n = 16）、前列腺癌患者（n = 4）和淋巴瘤患者（n = 8）。男女患者比例为3:4，超过75%的患者患有III至IV期疾病。从研究入组到6个月的治疗总平均费用相似：临床试验患者为57,542美元，对照患者为63,721美元（1998年美元；P =.4）
肿瘤学临床试验的多中心经济分析正在进行中。有可能设计出不会给数据管理人员和临床医生造成过重负担的策略。然而，这些研究需要癌症中心主任、财务部门人员、经济学家和卫生服务研究人员之间进行仔细的规划与协调。
