ClinicalTrials.gov 上注册的儿科心血管临床试验特征。
Characteristics of pediatric cardiovascular clinical trials registered on ClinicalTrials.gov.
机构信息
Department of Pediatrics, Duke University Medical Center, Durham, NC; Duke Clinical Research Institute, Durham, NC.
Duke Clinical Research Institute, Durham, NC.
出版信息
Am Heart J. 2014 Jun;167(6):921-9.e2. doi: 10.1016/j.ahj.2014.02.002. Epub 2014 Feb 17.
BACKGROUND
ClinicalTrials.gov is an National Institutes of Health-sponsored registry of federally and privately funded trials. We sought to determine fundamental characteristics of registered pediatric cardiovascular trials (PCVTs).
METHODS
A data set including 68,134 interventional clinical trials was downloaded from ClinicalTrials.gov and entered into a relational database. Aggregate data from PCVTs were compared with other trial specialties. Multivariable logistic regression was used to evaluate factors associated with improved trial quality metrics including blinding and randomization.
RESULTS
Between July 1, 2005, and September 27, 2010, 5035 (7%) registered trials targeted pediatric populations, including 213 PCVTs (4.2%), 1,176 pediatric infectious disease trials (23%), 664 pediatric mental health trials (13%), and 346 pediatric hematology/oncology trials (7%). Median (interquartile range) PCVT enrollment was 65 subjects (36-186) and median study duration was 2.3 years (1.3-3.7). The most common PCVTs targeted acquired diseases including hypertension (n = 41, 14%), obesity (n = 26, 9%), pulmonary hypertension (n = 25, 9%), and dyslipidemia (n = 19, 7%). Important factors associated with improved quality metrics included National Institutes of Health as opposed to industry funding (OR, 1.9; P < .0001); trial location (trials with both US and foreign enrollment vs trials with US only or foreign only enrollment, P = .02) and trials restricted to younger children as opposed to trials including adolescents (OR, 1.4; P < .0001).
CONCLUSION
PCVTs represent a small proportion of clinical trials relative to other pediatric subspecialties. Most PCVTs tend to parallel adult morbidities while there is a relative paucity of trials focused on congenital heart disease. These data may be useful to stakeholders in informing decisions regarding the conduct of PCVTs, and to provide insight into mechanisms to advance PCVT infrastructure.
背景
ClinicalTrials.gov 是美国国立卫生研究院（National Institutes of Health）赞助的注册处，负责登记联邦和私人资助的试验。我们旨在确定注册的儿科心血管试验（PCVT）的基本特征。
方法
从 ClinicalTrials.gov 下载了一个包含 68134 项干预性临床试验的数据集，并将其输入关系数据库。将 PCVT 的汇总数据与其他试验专业进行比较。多变量逻辑回归用于评估与提高试验质量指标相关的因素，包括盲法和随机化。
结果
2005 年 7 月 1 日至 2010 年 9 月 27 日，有 5035 项（7%）注册试验针对儿科人群，其中包括 213 项 PCVT（4.2%）、1176 项儿科传染病试验（23%）、664 项儿科心理健康试验（13%）和 346 项儿科血液肿瘤学/肿瘤学试验（7%）。PCVT 招募的中位数（四分位距）为 65 例（36-186 例），中位研究时间为 2.3 年（1.3-3.7 年）。最常见的 PCVT 针对获得性疾病，包括高血压（n = 41，14%）、肥胖症（n = 26，9%）、肺动脉高压（n = 25，9%）和血脂异常（n = 19，7%）。与提高质量指标相关的重要因素包括美国国立卫生研究院（National Institutes of Health）而非工业资金（比值比，1.9；P <.0001）；试验地点（既有美国参与者也有国外参与者的试验与仅有美国或仅有国外参与者的试验相比，P =.02）和仅招募年龄较小儿童的试验与包括青少年的试验相比（比值比，1.4；P <.0001）。
结论
PCVT 相对于其他儿科亚专业而言，在临床试验中所占比例较小。大多数 PCVT 倾向于与成人发病率平行，而针对先天性心脏病的试验相对较少。这些数据可能有助于利益相关者在开展 PCVT 方面做出决策，并为改善 PCVT 基础设施的机制提供深入了解。
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