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首页> 外文期刊>Journal of Oncology Practice >Clinical Trial Metrics: The Complexity of Conducting Clinical Trials in North American Cancer Centers
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Clinical Trial Metrics: The Complexity of Conducting Clinical Trials in North American Cancer Centers

机译:临床试验指标:北美癌症中心进行临床试验的复杂性

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PURPOSE:Cancer clinical trials offices (CTOs) support the investigation of cancer prevention, early detection, and treatment at cancer centers across North America. CTOs are a centralized resource for clinical trial conduct and typically use research staff with expertise in four functional areas of clinical research: finance, regulatory, clinical, and data operations. To our knowledge, there are no publicly available benchmark data sets that characterize the size, cost, volume, and efficiency of these offices, nor whether the metrics differ by National Cancer Institute (NCI) designation. The Association of American Cancer Institutes (AACI) Clinical Research Innovation (CRI) steering committee developed a survey to address this knowledge gap.METHODS:An 11-question survey that addressed CTO budget, accrual and trial volume, full-time equivalents (FTEs), staff turnover, and activation timelines was developed by the AACI CRI steering committee and sent to 92 academic cancer research centers in North America (n = 90 in the United States; n = 2 in Canada), with 79 respondents completing the survey (86% completion rate).RESULTS:The number of FTE employees working in the CTOs ranged from 4.5 to 811 (median, 104). The median number of analytic cases (ie, newly diagnosed or received first course of treatment) reported by the main center was 3,856. Annual CTO budgets ranged from $250,000 to $23,900,000 (median, $8.2 million). The median trial activation time, based on 61 centers, was 167 days. The median number of accruals per center was 480 (range, 5-6,271) and median number of trials per center was 282 (range, 31-1,833). Budget and FTE ranges varied by NCI designation.CONCLUSION:The response rate to the survey was high. These data will allow cancer centers to evaluate their CTO infrastructure, funding, portfolio, and/or accrual goals as compared with peers. A wide range in each of the outcomes was noted, in keeping with the wide variation in size and scope of cancer center CTOs across the United States and Canada. These variations may warrant additional investigation.
机译:目的:癌症临床试验办公室(CTOS)支持北美癌症中心的癌症预防,早期检测和治疗的调查。 CTO是临床试验行为的集中资源,通常使用研究人员在临床研究中的四个功能领域拥有专业知识:金融,监管,临床和数据操作。据我们所知,没有公开的基准数据集,这些数据集是这些办事处的尺寸,成本,卷和效率,也不是国家癌症研究所(NCI)指定的不同。美国癌症机构(AACI)临床研究创新(CRI)指导委员会的协会制定了调查,以解决这一知识差距。 ,工作人员营业额和激活时间表是由AACI CRI指导委员会制定的,并送到北美的92名学术癌症研究中心(美国N = 90;加拿大N = 2),79名受访者完成调查(86 %完成率)。结果:在CTO中工作的FTE员工的数量从4.5到811(中位数,104)。主中心报告的分析病例(即新诊断或接受的第一课程)的中位数为3,856。年度CTO预算从250,000美元到23,900,000美元(中位数,820万美元)。基于61个中心的中位试验时间为167天。每个中心的计数器数量为480(范围,5-6,271),每个中心的中位数的试验数为282(范围31-1,833)。 NCI指定的预算和FTE范围各不相同。结论:调查的响应率很高。这些数据将允许癌症中心与同龄人相比,评估其CTO基础设施,资金,投资组合和/或应计数目标。注意到每个结果中的广泛范围是在美国和加拿大的癌症中心CTO的大小和范围的广泛变化中。这些变化可能需要额外调查。

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