UNC Lineberger Comprehensive Cancer Center, University of North Carolina at Chapel Hill, Chapel Hill, NC.
Huntsman Cancer Institute, University of Utah, Salt Lake City, UT.
JCO Oncol Pract. 2021 Jan;17(1):e77-e93. doi: 10.1200/OP.20.00501. Epub 2020 Nov 13.
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.
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).
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.
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.
癌症临床试验办公室（CTO）支持北美癌症中心癌症预防、早期发现和治疗的研究。CTO 是临床试验进行的集中资源，通常使用在临床研究四个功能领域具有专业知识的研究人员：财务、监管、临床和数据运营。据我们所知，没有公开的基准数据集可以描述这些办公室的规模、成本、数量和效率，也没有关于这些指标是否因美国国立癌症研究所（NCI）的指定而有所不同的信息。美国癌症协会（AACI）临床研究创新（CRI）指导委员会开发了一项调查来解决这一知识空白。
AACI CRI 指导委员会制定了一份由 11 个问题组成的调查问卷，内容涉及 CTO 预算、入组和试验数量、全职员工（FTE）、员工流动率和启动时间表，并分发给北美 92 家学术癌症研究中心（美国 90 家，加拿大 2 家），79 家机构完成了调查（完成率 86%）。
在 CTO 工作的 FTE 员工人数从 4.5 到 811 人不等（中位数为 104 人）。主要中心报告的分析病例数（即新诊断或首次接受治疗）中位数为 3856 例。CTO 年度预算从 25 万美元到 2390 万美元不等（中位数为 820 万美元）。基于 61 个中心的数据，试验启动时间的中位数为 167 天。每个中心的入组中位数为 480 例（范围为 5-6271 例），每个中心的试验中位数为 282 例（范围为 31-1833 例）。预算和 FTE 范围因 NCI 的指定而有所不同。
调查的回复率很高。这些数据将使癌症中心能够将其 CTO 基础设施、资金、组合和/或入组目标与同行进行比较。每个结果的范围都很广，与美国和加拿大癌症中心 CTO 的规模和范围的广泛变化一致。这些差异可能需要进一步调查。
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