Characteristics of Clinical Trials Registered in ClinicalTrials.gov, 2007-2010
Characteristics of Clinical Trials Registered in ClinicalTrials.gov, 2007-2010
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DOI：
10.1001/jama.2012.3424
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发表时间：
2012-05-02
影响因子：
120.7
通讯作者：
Tasneem, Asba
中科院分区：
文献类型：
--
作者：
Califf, Robert M.;Zarin, Deborah A.;Tasneem, Asba
背景最近的报告强调了基于指南的治疗建议与支持这些建议的临床试验证据之间的差距。目的考察在ClinicalTrials.gov数据库中注册的介入临床试验的基本特征。方法2010年9月27日从ClinicalTrials.gov下载包含96 346项临床研究的数据集，并将其输入关系数据库以分析汇总数据。确定了干预性试验，重点分析了3个临床专科--心血管、心理健康和肿瘤学--这三个专科合计包含了美国最多的残疾调整寿命年损失。主要结果衡量登记的临床试验的特征，作为试验登记处中报告的数据元素；这些特征随着时间的变化；作为临床专业的功能特征的差异；结果共登记介入临床试验28881篇(2004年10月-2007年9月)至40970篇(2007年10月-2010年9月)，缺失数据元素的数量总体呈下降趋势。2007至2010年间登记的大多数干预试验规模较小，62%的参与者人数在100人或更少。许多临床试验是单中心的(66%；24788/37520)，由工业或美国国立卫生研究院(NIH)以外的组织资助(47%；17592/37520)。根据临床专业、赞助商类型以及报道的DMCs、随机和盲法的使用，所报道的方法的异质性很明显。例如，在工业赞助与NIH赞助的试验(调整后的优势比[OR]，0.11；95%CI，0.09-0.14)、早期阶段的VS阶段试验(调整后的OR，0.83；95%的CI，0.76-0.91)以及心理健康试验中，使用DMCs的报告较少使用其他两个专科的试验。在类似的比较中，随机和盲法在早期阶段、肿瘤学和设备试验中报告的频率较低。结论在ClinicalTrials.gov注册的临床试验以小型试验为主，在方法学方法上存在显著的异质性，包括报告的随机化、盲法和DMCS的使用。贾玛2012；307(17)：1838-1847 www.jama.com
Context Recent reports highlight gaps between guidelines-based treatment recommendations and evidence from clinical trials that supports those recommendations. Strengthened reporting requirements for studies registered with ClinicalTrials.gov enable a comprehensive evaluation of the national trials portfolio.Objective To examine fundamental characteristics of interventional clinical trials registered in the ClinicalTrials.gov database.Methods A data set comprising 96 346 clinical studies from ClinicalTrials.gov was downloaded on September 27, 2010, and entered into a relational database to analyze aggregate data. Interventional trials were identified and analyses were focused on 3 clinical specialties-cardiovascular, mental health, and oncology-that together encompass the largest number of disability-adjusted life-years lost in the United States.Main Outcome Measures Characteristics of registered clinical trials as reported data elements in the trial registry; how those characteristics have changed over time; differences in characteristics as a function of clinical specialty; and factors associated with use of randomization, blinding, and data monitoring committees (DMCs).Results The number of registered interventional clinical trials increased from 28 881(October 2004-September 2007) to 40 970 (October 2007-September 2010), and the number of missing data elements has generally declined. Most interventional trials registered between 2007 and 2010 were small, with 62% enrolling 100 or fewer participants. Many clinical trials were single-center (66%; 24 788/37 520) and funded by organizations other than industry or the National Institutes of Health (NIH) (47%; 17 592/37 520). Heterogeneity in the reported methods by clinical specialty; sponsor type; and the reported use of DMCs, randomization, and blinding was evident. For example, reported use of DMCs was less common in industry-sponsored vs NIH-sponsored trials (adjusted odds ratio [OR], 0.11; 95% CI, 0.09-0.14), earlier-phase vs phase 3 trials (adjusted OR, 0.83; 95% CI, 0.76-0.91), and mental health trials vs those in the other 2 specialties. In similar comparisons, randomization and blinding were less frequently reported in earlier-phase, oncology, and device trials.Conclusion Clinical trials registered in ClinicalTrials.gov are dominated by small trials and contain significant heterogeneity in methodological approaches, including reported use of randomization, blinding, and DMCs. JAMA. 2012;307(17):1838-1847 www.jama.com