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一项提高临床试验入组率的额外资助干预措施的随机对照试验。

A Randomized Controlled Trial of an Additional Funding Intervention to Improve Clinical Trial Enrollment.

机构信息

Clinical Network, Cancer Council Victoria

Department of Oncology, St Vincent’s Hospital

出版信息

J Natl Compr Canc Netw. 2017 Sep;15(9):1104-1110. doi: 10.6004/jnccn.2017.0150.

DOI:10.6004/jnccn.2017.0150
PMID:28874595
Abstract

A low proportion of adults with cancer are recruited to clinical trials. Cancer Council Victoria provides funding to clinical trial sites through its statewide Cancer Trials Management Scheme (CTMS). Historically, there appeared to be a relationship between budget-allocated funding and the number of patients recruited. A randomized controlled trial was conducted to test whether additional funding in 2013 would increase trial recruitment. A total of 18 trial centers ("sites") received usual CTMS funds, whereas 16 intervention sites received usual funds plus additional funds, proportional to recruitment in 2011; additional payments to sites in the intervention group ranged from $6,750 to $234,000 AUD (≈$6,750-$234,000 USD at the time). This represented an average 11.8% (interquartile range [IQR], 8.0%, 12.3%) increase in sites' budgets. Sites were required to use the funds with the aim of increasing recruitment. The study end point was the number of new participants recruited to trials in 2013. An online survey assessed strategies used to increase recruitment. The median number of new trial recruits per site in 2013 was 21 (IQR, 5-39) in the control arm and 12.5 (IQR, 3.5-44.5) in the intervention arm. The ratio of new trial recruitment numbers at the intervention sites compared with control sites in 2013, adjusting for respective 2012 numbers and institution type, was 0.99 (95% CI, 0.69, 1.43; =.96). The survey revealed most intervention sites used funding to increase staffing. Additional funding at a site level did not lead to a contemporaneous increase in trial recruitment.

摘要

癌症患者参与临床试验的比例较低。维多利亚癌症委员会通过其全州癌症试验管理计划(CTMS)为临床试验站点提供资金。从历史上看,预算分配资金与招募的患者数量之间似乎存在关系。一项随机对照试验旨在检验 2013 年额外的资金是否会增加试验招募。共有 18 个试验中心(“站点”)获得了常规 CTMS 资金,而 16 个干预站点获得了常规资金和额外资金,与 2011 年的招募人数成正比;干预组中站点的额外付款从 6750 澳元到 234000 澳元不等(≈$6750-$234000 美元)。这代表着站点预算平均增加了 11.8%(四分位距 [IQR],8.0%,12.3%)。站点需要使用这些资金来增加招募。研究终点是 2013 年新参与者招募到试验的数量。在线调查评估了增加招募的策略。2013 年,对照组每个站点的新试验参与者中位数为 21(IQR,5-39),干预组为 12.5(IQR,3.5-44.5)。2013 年,干预站点与对照站点的新试验招募数量之比,根据各自 2012 年的数量和机构类型进行调整,为 0.99(95%置信区间,0.69,1.43;=0.96)。调查显示,大多数干预站点都使用资金来增加人员配备。但站点层面的额外资金并没有导致试验招募的同期增加。

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