Unsuccessful trial accrual and human subjects protections: An empirical analysis of recently closed trials
Unsuccessful trial accrual and human subjects protections: An empirical analysis of recently closed trials
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DOI：
10.1177/1740774514558307
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发表时间：
2015-02-01
期刊：
影响因子：
2.7
通讯作者：
MacKinnon, Nathalie
中科院分区：
文献类型：
--
作者：
Carlisle, Benjamin;Kimmelman, Jonathan;MacKinnon, Nathalie
风险的伦理评估-临床试验中的益处取决于解决激发研究的研究问题的可行性。目的确定由于不成功的患者招募而处于不能有意义地解决其主要研究目标的风险中的患者招募比例和数量。方法我们使用美国国家医学图书馆临床试验注册表收集所有启动的2期和3期临床试验2011年登记关闭的干预性临床试验。然后，我们确定了因招募失败而终止的数量，以及在招募的人类受试者数量低于目标数量的85%后关闭的数量。五个因素进行了测试，与不成功accumulation.Results的2579个合格的试验，481（19%）要么终止失败的应计或完成少于85%的预期入组，严重影响其统计能力。与不成功的累积相关的因素包括更多的资格标准（p=0.013），非行业资金（25%对16%，p
Background Ethical evaluation of risk-benefit in clinical trials is premised on the achievability of resolving research questions motivating an investigation.Objective To determine the fraction and number of patients enrolled in trials that were at risk of not meaningfully addressing their primary research objective due to unsuccessful patient accrual.Methods We used the National Library of Medicine clinical trial registry to capture all initiated phases 2 and 3 intervention clinical trials that were registered as closed in 2011. We then determined the number that had been terminated due to unsuccessful accrual and the number that had closed after less than 85% of the target number of human subjects had been enrolled. Five factors were tested for association with unsuccessful accrual.Results Of 2579 eligible trials, 481 (19%) either terminated for failed accrual or completed with less than 85% expected enrolment, seriously compromising their statistical power. Factors associated with unsuccessful accrual included greater number of eligibility criteria (p=0.013), non-industry funding (25% vs 16%, p