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首页> 外文期刊>Journal of stroke and cerebrovascular diseases: The official journal of National Stroke Association >Low patient enrollment sites in multicenter randomized clinical trials of cerebrovascular diseases: Associated factors and impact on trial outcomes
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Low patient enrollment sites in multicenter randomized clinical trials of cerebrovascular diseases: Associated factors and impact on trial outcomes

机译：脑血管疾病多中心随机临床试验的患者入院位低：相关因素及其对试验结果的影响

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摘要

Wide variability in patient enrollment among participating sites is a common phenomenon in multicenter trials. We examined stroke trial-related factors associated with the proportion of sites with low patient enrollment and the effect of these low-enrollment sites on trial outcome. We identified efficacy clinical trials enrolling patients with cerebrovascular diseases between 1980 and 2008 using an electronic database. The trials included in our analyses were multicenter randomized controlled trials (RCTs) comparing efficacy endpoints between two or more treatment groups and having >5 sites. Sites enrolling <10 patients or <2% of total trial patients were defined as low- enrollment sites. Trials were classified into tertiles based on the proportion of low-enrollment sites. Factors associated with trials that could be ascertained through a systematic review of published data were identified and examined. The association between low enrollment and a conclusive trial designation (defined by the ability to reject the primary null hypothesis either at or before target enrollment or demonstrate equivalenceoninferiority with adequate statistical power, depending on the initial design) was assessed using a multivariate logistic regression model. We identified 51 trials that met the inclusion criteria and provided information regarding patients enrolled per center. A total of 3059 participating centers enrolled a total of 53,742 trial participants; 78% of the participating sites enrolled <2% of trial participants. Trials enrolling acute stroke patients (within 24 hours of symptom onset) or those evaluating endovascular/surgical intervention had a higher proportion of low-enrollment sites (<10 patients per site). Studies with a higher proportion of low-enrollment sites were more likely to target acute stroke patients and less likely to randomize ≥1000 patients, use general efficacy endpoints, and stratify by site. There was no association between the studies with a higher proportion of low-enrollment sites and designation as a conclusive trial. A better understanding of factors associated with low-enrollment sites in clinical trials and the impact on a trial's ability to demonstrate conclusive outcomes may lead to strategies to make trial enrollments more efficient and cost-effective.
机译：在多中心试验中，参与部位之间的患者入院率差异很大。我们检查了与卒中试验相关的因素，这些因素与患者入院率低的位点的比例以及这些低入院率的位点对试验结局的影响有关。我们确定了使用电子数据库在1980年至2008年之间招募脑血管疾病患者的临床疗效试验。我们的分析中包括的试验是多中心随机对照试验（RCT），用于比较两个或多个治疗组之间的疗效终点并具有> 5个位点。招募少于10名患者或总试验患者的少于2％的地点被定义为低招募地点。根据低入学地点的比例，将试验分为三分位数。通过与公开数据的系统回顾可以确定并检查与试验相关的因素。使用多因素Logistic回归评估了低入组人数与结论性试验指定之间的关联（定义为在目标入选时或之前拒绝主要无效假设或具有足够的统计能力的等效性/非劣等性，取决于初始设计的能力），该变量采用了多元Logistic回归分析模型。我们确定了51项符合纳入标准的试验，并提供了有关每个中心入组患者的信息。共有3059个参与中心招募了53,742名试验参与者; 78％的参与站点的参与者少于试验参与者的2％。纳入急性卒中患者（症状发作后24小时内）或评估血管内/手术干预的试验中，低入院部位的比例更高（每个部位<10名患者）。低入院位点比例较高的研究更有可能针对急性卒中患者，而对≥1000名患者进行随机分组，使用一般疗效终点和按部位分层的可能性较小。低入院率的较高比例的研究与指定为最终试验之间没有关联。更好地了解与临床试验中低入院位点相关的因素以及对试验证明结论性结果的能力的影响，可能会导致提高试验入组效率和成本效益的策略。

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