Discontinuation and Nonpublication of Randomized Clinical Trials Conducted in Children
Discontinuation and Nonpublication of Randomized Clinical Trials Conducted in Children
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DOI：
10.1542/peds.2016-0223
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发表时间：
2016-09-01
期刊：
影响因子：
8
通讯作者：
Bourgeois, Florence
中科院分区：
文献类型：
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作者：
Pica, Natalie;Bourgeois, Florence
背景：试验中止和不发表是研究资源的潜在浪费，并导致医学证据的妥协。鉴于在儿童身上进行试验遇到的挑战，儿科试验可能特别容易受到这些结果的影响。我们的目的是确定在儿童人群中进行的随机临床试验(RCT)的中断和未发表的流行率。方法：对登记在临床试验中的儿童随机临床试验进行回顾性横断面研究。政府从2008年到2010年。数据来自注册中心和相关出版物(2015年9月1日最终检索)。结果：在559项试验中，104项(19%)提前终止，估计有8369名儿科参与者。患者负担困难(37%)是最常被引用的停药原因。与学术机构相比，如果试验是由行业资助的，那么中止的可能性较小(优势比[OR]0.46，95%可信区间[CI]0.27-0.77)。在455项已完成的试验中，136项(30%)未发表，代表69 165名儿科参与者。42项未发表的试验公布了临床试验的结果。政府。由行业资助的试验在24个月和36个月时导致未发表的可能性是前者的两倍以上(OR 2.21，95%CI 1.35-3.64；OR 3.12，95%CI 1.6-6.08)，并且与学术界资助的试验(33个月比24个月，P<；.001)相比，平均发表时间更长。结论：在这一样本的儿科随机对照试验中，停止和未发表的情况很常见，数千名儿童暴露在不会导致信息性或已发表结果的干预措施中。试验资金来源是这些结果的一个重要决定因素，学术和行业赞助商都造成了效率低下。
BACKGROUND: Trial discontinuation and nonpublication represent potential waste in research resources and lead to compromises in medical evidence. Pediatric trials may be particularly vulnerable to these outcomes given the challenges encountered in conducting trials in children. We aimed to determine the prevalence of discontinuation and nonpublication of randomized clinical trials (RCTs) conducted in pediatric populations.METHODS: Retrospective, cross-sectional study of pediatric RCTs registered in ClinicalTrials. gov from 2008 to 2010. Data were collected from the registry and associated publications identified (final search on September 1, 2015).RESULTS: Of 559 trials, 104 (19%) were discontinued early, accounting for an estimated 8369 pediatric participants. Difficulty with patient accrual (37%) was the most commonly cited reason for discontinuation. Trials were less likely to be discontinued if they were funded by industry compared with academic institutions (odds ratio [OR] 0.46, 95% confidence interval [CI] 0.27-0.77). Of the 455 completed trials, 136 (30%) were not published, representing 69 165 pediatric participants. Forty-two unpublished trials posted results on ClinicalTrials. gov. Trials funded by industry were more than twice as likely to result in nonpublication at 24 and 36 months (OR 2.21, 95% CI 1.35-3.64; OR 3.12, 95% CI 1.6-6.08, respectively) and had a longer mean time to publication compared with trials sponsored by academia (33 vs 24 months, P < .001).CONCLUSIONS: In this sample of pediatric RCTs, discontinuation and nonpublication were common, with thousands of children exposed to interventions that did not lead to informative or published findings. Trial funding source was an important determinant of these outcomes, with both academic and industry sponsors contributing to inefficiencies.