Sponsorship and design characteristics of trials registered in ClinicalTrials.gov
Sponsorship and design characteristics of trials registered in ClinicalTrials.gov
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DOI：
10.1016/j.cct.2013.01.004
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发表时间：
2013-03-01
影响因子：
2.2
通讯作者：
Wagner, Todd H.
中科院分区：
文献类型：
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作者：
Roumiantseva, Dina;Carini, Simona;Wagner, Todd H.
目标：我们检查 ClinicalTrials.gov 在多大程度上实现了对人体临床试验提供监督和透明度的目标。我们分析了截至 2011 年 6 月的 ClinicalTrials.gov 数据库内容，按申办者类型比较了干预措施、医疗条件和试验特征。我们还对不完整的数据进行了详细分析。 结果：在仅由政府资助的试验中（N=9252），36%为观察性试验，64%为干预性试验；相比之下，几乎所有（90%）仅由行业赞助的试验都是干预性的。仅由行业赞助的干预试验 (N=30,036) 最有可能报告药物干预 (81%)，其次是生物制剂 (9%) 和设备 (8%)。仅限政府的干预试验 (N=5886) 比仅限行业的试验更有可能测试行为干预 (28%) 和程序 (13%) (p
Objective: We examine the extent to which ClinicalTrials.gov is meeting its goal of providing oversight and transparency of clinical trials with human subjects. We analyzed the ClinicalTrials.gov database contents as of June 2011, comparing interventions, medical conditions, and trial characteristics by sponsor type. We also conducted a detailed analysis of incomplete data.Results: Among trials with only government sponsorship (N=9252), 36% were observational and 64% interventional; in contrast, almost all (90%) industry-only sponsored trials were interventional. Industry-only sponsored interventional trials (N=30,036) were most likely to report a drug intervention (81%), followed by biologics (9%) and devices (8%). Government-only interventional trials (N=5886) were significantly more likely to test behavioral interventions (28%) and procedures (13%) than industry-only trials (p