Outcome reporting among drug trials registered in ClinicalTrials.gov.
Outcome reporting among drug trials registered in ClinicalTrials.gov.
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DOI：
10.7326/0003-4819-153-3-201008030-00006
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发表时间：
2010-08-03
影响因子：
39.2
通讯作者：
Mandl KD
中科院分区：
文献类型：
--
作者：
Bourgeois FT;Murthy S;Mandl KD
临床试验注册被广泛用于提高试验及其结果的透明度。描述ClinicalTrials.gov中列出的药物试验的特征，并检查这些试验的资金来源是否与有利的已发表结果相关。一项2000年至2006年期间进行的抗抑郁药、抗精神病药、质子泵抑制剂和血管扩张剂安全性和有效性试验的观察性研究。ClinicalTrials.gov是一个基于网络的临床试验注册中心，于1999年推出。确定了5种关注药物类别试验产生的出版物，并对试验记录和出版物中的数据进行了摘要，包括注册时间、研究设计要素、资金来源、出版日期和研究结局。评估是基于行业，政府机构和非营利或非联邦组织的主要资金类别。在546项药物试验中，346项（63%）主要由行业资助，74项（14%）由政府资助，126项（23%）由非营利或非联邦组织资助。由行业资助的试验更有可能是3期或4期试验（88.7%;组间P < 0.001），在对照试验中使用活性对照药物（36.8%;各组间P = 0.010），多中心（89.0%;各组P < 0.001），并招募更多的参与者（中位数样本量，306名参与者;各组P < 0.001）。总体而言，362项（66.3%）试验已发表结果。在85.4%的出版物中，行业资助的试验报告了积极的结果，而政府资助的试验为50.0%，非营利性或非联邦组织资助的试验为71.9%（P < 0.001）。由非营利或非联邦来源资助的试验，与没有行业资助的试验相比，也更有可能报告积极的结果（85.0%对61.2%; P = 0.013）。研究完成后24个月内的试验发表率从行业资助的试验中的32.4%到非营利或非联邦组织资助的无行业贡献的试验中的56.2%（各组间P = 0.005）。试验的发表状态并非总能得到确认，这可能导致分类错误。关于研究方案和综合试验结果的其他信息不可用，无法进一步探索资金来源和结局报告之间相关性的潜在因素。在这个注册药物试验的样本中，由行业资助的试验在研究完成后2年内发表的可能性较小，并且比其他来源资助的试验更有可能报告积极的结果。国家医学图书馆和国家儿童健康和人类发展研究所，国家卫生研究院。
Clinical trial registries are in widespread use to promote transparency around trials and their results. To describe characteristics of drug trials listed in ClinicalTrials.gov and examine whether the funding source of these trials is associated with favorable published outcomes. An observational study of safety and efficacy trials for anticholesteremics, antidepressants, antipsychotics, proton-pump inhibitors, and vasodilators conducted between 2000 and 2006. ClinicalTrials.gov, a Web-based registry of clinical trials launched in 1999. Publications resulting from the trials for the 5 drug categories of interest were identified, and data were abstracted on the trial record and publication, including timing of registration, elements of the study design, funding source, publication date, and study outcomes. Assessments were based on the primary funding categories of industry, government agencies, and nonprofit or nonfederal organizations. Among 546 drug trials, 346 (63%) were primarily funded by industry, 74 (14%) by government sources, and 126 (23%) by nonprofit or nonfederal organizations. Trials funded by industry were more likely to be phase 3 or 4 trials (88.7%; P < 0.001 across groups), to use an active comparator in controlled trials (36.8%; P = 0.010 across groups), to be multicenter (89.0%; P < 0.001 across groups), and to enroll more participants (median sample size, 306 participants; P < 0.001 across groups). Overall, 362 (66.3%) trials had published results. Industry-funded trials reported positive outcomes in 85.4% of publications, compared with 50.0% for government-funded trials and 71.9% for nonprofit or nonfederal organization–funded trials (P < 0.001). Trials funded by nonprofit or nonfederal sources with industry contributions were also more likely to report positive outcomes than those without industry funding (85.0% vs. 61.2%; P = 0.013). Rates of trial publication within 24 months of study completion ranged from 32.4% among industry-funded trials to 56.2% among nonprofit or nonfederal organization–funded trials without industry contributions (P = 0.005 across groups). The publication status of a trial could not always be confirmed, which could result in misclassification. Additional information on study protocols and comprehensive trial results were not available to further explore underlying factors for the association between funding source and outcome reporting. In this sample of registered drug trials, those funded by industry were less likely to be published within 2 years of study completion and were more likely to report positive outcomes than were trials funded by other sources. National Library of Medicine and National Institute of Child Health and Human Development, National Institutes of Health.
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