A Randomized Controlled Trial of an Additional Funding Intervention to Improve Clinical Trial Enrollment
A Randomized Controlled Trial of an Additional Funding Intervention to Improve Clinical Trial Enrollment
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DOI：
10.6004/jnccn.2017.0150
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发表时间：
2017-09-01
影响因子：
13.4
通讯作者：
Millar, Jeremy
中科院分区：
文献类型：
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作者：
Parker, Catriona;Snyder, Raymond;Millar, Jeremy
背景：较低比例的成年癌症患者被纳入临床试验。维多利亚州癌症委员会通过其全州癌症试验管理计划(CTMS)为临床试验地点提供资金。从历史上看，预算分配的资金和招募的患者数量之间似乎存在关系。进行了一项随机对照试验，以测试2013年的额外资金是否会增加审判征聘。方法：共有18个试验中心(“站点”)获得常规的CTMS资金，而16个干预站点获得常规资金外加额外资金，与2011年的招募比例成比例；向干预组站点支付的额外费用从6,750美元到234,000澳元不等(当时大约为6,750美元到234,000美元)。这代表着网站预算的平均增长11.8%(四分位数范围[IQR]，8.0%，12.3%)。各网站被要求使用这笔资金，目的是增加招聘。研究的终点是2013年招募参加试验的新参与者的数量。一项在线调查评估了增加招聘的策略。结果：2013年，控制组和干预组每个试验点的新兵人数中位数分别为21人(智商，5-39)和12.5人(智商，3.5-44.5)。2013年，干预地点与对照地点的新试验招募人数之比为0.99(95%可信区间，0.69，1.43；P=.96)。调查显示，大多数干预网站都使用了资金来增加人员配备。结论：现场水平的额外资金并没有导致同期试验招募的增加。
Background: 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. Methods: 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 (approximate to$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. Results: 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; P=.96). The survey revealed most intervention sites used funding to increase staffing. Conclusions: Additional funding at a site level did not lead to a contemporaneous increase in trial recruitment.