1 Duke University Medical Center, Durham, North Carolina; and.
Ann Am Thorac Soc. 2013 Oct;10(5):411-7. doi: 10.1513/AnnalsATS.201305-111OC.
ClinicalTrials.gov is the largest trial registry in the world. Strengthened registration requirements, including federal mandates in 2007, have increased study representation. A systematic evaluation of all registered studies has been limited by the absence of an aggregate data set and specialty-specific search terms.
We leveraged a newly transformed database containing annotated data from ClinicalTrials.gov to define the portfolio of interventional clinical research in pulmonary, critical care, and sleep medicine.
Analysis was restricted to studies registered after September 2007 through September 2010 and defined as "interventional" (n = 40,970). A specialty-specific study data set (n = 2,226) was created using disease condition terms provided by data submitters and medical subject heading terms generated by a National Library of Medicine algorithm. Trial characteristics were extracted and summarized using descriptive statistics.
Pulmonary, critical care, and sleep medicine trials composed 5.4% of all interventional studies registered over the 3-year period. In contrast, oncology and cardiovascular disease composed 21.9 and 8.4% of trials, respectively. Within pulmonary trials, asthma and chronic obstructive pulmonary disease were the most studied conditions (27.4 and 21.8% of studies, respectively), and measures of lung function or safety were the most frequent primary outcomes. Nearly two-thirds of trials indicated enrollment of 100 patients or fewer, and a majority of studies were phase II or III trials. The single largest funding source (43.5%) was industry, and study characteristics varied by funding source.
We applied a novel approach to describe the portfolio of interventional clinical research in pulmonary medicine. Our results indicate a disparity between trial representation and the burden of respiratory disease. Resources should be targeted across the spectrum of pulmonary research to address this discrepancy.
ClinicalTrials.gov 是世界上最大的试验注册库。2007 年加强了注册要求，包括联邦政府的要求，这增加了研究的代表性。由于缺乏综合数据集和特定专业的搜索词，对所有已注册研究进行系统评估的工作受到限制。
我们利用一个新转化的数据库，其中包含来自 ClinicalTrials.gov 的注释数据，来定义在肺部、危重病和睡眠医学领域的干预性临床研究组合。
分析仅限于 2007 年 9 月至 2010 年 9 月期间注册的研究，并定义为“干预性”（n=40970）。使用数据提交者提供的疾病状况术语和美国国立医学图书馆算法生成的医学主题词术语，创建了一个特定专业的研究数据集（n=2226）。使用描述性统计方法提取和总结试验特征。
在 3 年期间，肺部、危重病和睡眠医学试验占所有注册干预性研究的 5.4%。相比之下，肿瘤学和心血管疾病分别占试验的 21.9%和 8.4%。在肺部试验中，哮喘和慢性阻塞性肺疾病是研究最多的疾病（分别占研究的 27.4%和 21.8%），并且肺功能或安全性的衡量标准是最常见的主要结果。近三分之二的试验表示纳入了 100 名或更少的患者，大多数研究是 2 期或 3 期试验。最大的单一资金来源（43.5%）是工业界，研究特征因资金来源而异。
我们采用了一种新方法来描述肺部医学中的干预性临床研究组合。我们的结果表明，试验代表性与呼吸道疾病负担之间存在差距。应该针对肺部研究的各个方面来分配资源，以解决这一差异。
