BACKGROUND Data monitoring committees advise on clinical trial conduct through appraisal of emerging data to ensure participant safety and scientific integrity. While consideration of their use is recommended for trials performed with vulnerable populations, previous research has shown that data monitoring committees are reported infrequently in publications of pediatric randomized controlled trials. We aimed to assess the frequency of reported data monitoring committee adoption in ClinicalTrials.gov registry records and to examine the influence of key trial characteristics. METHODS We conducted a cross-sectional data analysis of all randomized controlled trials performed exclusively in a pediatric population and registered in ClinicalTrials.gov between 2008 and 2021. We used the Access to Aggregate Content of ClinicalTrials.gov database to retrieve publicly available information on trial characteristics and data on safety results. Abstracted data included reported trial design and conduct parameters, population and intervention characteristics, reasons for prematurely halting, serious adverse events, and mortality outcomes. We performed descriptive analyses on the collected data and explored the influence of clinical, methodological, and operational trial characteristics on the reported adoption of data monitoring committees. RESULTS We identified 13,928 pediatric randomized controlled trial records, of which 39.7% reported adopting a data monitoring committee, 49.0% reported not adopting a data monitoring committee, and 11.3% did not answer on this item. While the number of registered pediatric trials has been increasing since 2008, we found no clear time trend in the reported adoption of data monitoring committees. Data monitoring committees were more common in multicenter trials (50.6% vs 36.9% for single-center), multinational trials (60.2% vs 38.7% for single-country), National Institutes of Health-funded (60.3% vs 40.1% for industry-funded or 37.5% for other funders), and placebo-controlled (47.6% vs 37.5% for other types of control groups). Data monitoring committees were also more common among trials enrolling younger participants, trials employing blinding techniques, and larger trials. Data monitoring committees were more common in trials with at least one serious adverse event (52.6% vs 38.4% for those without) as well as for trials with reported deaths (70.3% vs 38.9% for trials without reported deaths). In all, 4.9% were listed as halted prematurely, most often due to low accrual rates. Trials with a data monitoring committee were more often halted for reasons related to scientific data than trials without a data monitoring committee (15.7% vs 7.3%). CONCLUSION According to registry records, the use of data monitoring committees in pediatric randomized controlled trials was more frequent than previously reported in reviews of published trial reports. The use of data monitoring committees varied across key clinical and trial characteristics based on which their use is recommended. Data monitoring committees may still be underutilized in pediatric trials, and reporting of this item could be improved.

中文翻译：

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在 ClinicalTrials.gov 上注册的儿科随机对照试验的数据监测委员会。

背景数据监测委员会通过评估新出现的数据就临床试验的实施提供建议，以确保参与者的安全和科学完整性。虽然建议在针对弱势群体进行的试验中考虑使用它们，但先前的研究表明，在儿科随机对照试验的出版物中很少报道数据监测委员会。我们的目的是评估 ClinicalTrials.gov 注册记录中报告数据监测委员会采用的频率，并检查关键试验特征的影响。方法 我们对 2008 年至 2021 年间仅在儿科人群中进行并在 ClinicalTrials.gov 注册的所有随机对照试验进行了横断面数据分析。我们使用 Access to Aggregate Content of ClinicalTrials.gov 数据库来检索有关试验的公开信息特征和安全结果数据。摘要数据包括报告的试验设计和实施参数、人群和干预特征、提前停止的原因、严重不良事件和死亡率结果。我们对收集的数据进行了描述性分析，并探讨了临床、方法学和操作试验特征对报告的数据监测委员会采用的影响。结果 我们识别了 13,928 条儿科随机对照试验记录，其中 39.7% 报告采用了数据监测委员会，49.0% 报告未采用数据监测委员会，11.3% 没有对此项目做出回答。虽然自 2008 年以来注册儿科试验的数量一直在增加，但我们发现所报告的数据监测委员会的采用没有明显的时间趋势。数据监测委员会在多中心试验（50.6% vs 单中心 36.9%）、跨国试验（60.2% vs 单一国家 38.7%）、美国国立卫生研究院资助的试验（60.3% vs 40.1%）中更为常见。资助者或其他资助者为 37.5%），以及安慰剂对照（47.6% 对比其他类型对照组为 37.5%）。数据监测委员会在招募年轻参与者的试验、采用盲法技术的试验以及规模更大的试验中也更为常见。数据监测委员会在至少有一项严重不良事件的试验中更为常见（52.6% vs 没有报告死亡的试验为 38.4%），以及报告死亡的试验（70.3% vs 没有报告死亡的试验为 38.9%）。总共有 4.9% 被列为提前停止，最常见的原因是应计利率较低。与没有数据监测委员会的试验相比，有数据监测委员会的试验更常因与科学数据相关的原因而停止（15.7% vs 7.3%）。结论 根据登记记录，儿科随机对照试验中数据监测委员会的使用比之前已发表的试验报告审查中报告的更为频繁。数据监测委员会的使用因关键临床和试验特征而异，建议根据这些特征使用数据监测委员会。数据监测委员会在儿科试验中可能仍未得到充分利用，该项目的报告可以改进。