Publication of NIH funded trials registered in ClinicalTrials.gov: cross sectional analysis

Publication of NIH funded trials registered in ClinicalTrials.gov: cross sectional analysis
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DOI:
10.1136/bmj.d7292
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发表时间:
2012-01-03
影响因子:
105.7
通讯作者:
Krumholz, Harlan M.
Krumholz, Harlan M.
中科院分区:
医学1区
文献类型:
--
作者:
Ross, Joseph S.;Tse, Tony;Krumholz, Harlan M.

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目的回顾美国国立卫生研究院(NIH)资助的临床试验在Medline检索的同行评议生物医学期刊上发表的模式ClinicalTrials.gov。(clinicaltrials.gov),一个由美国国家医学图书馆维护的试验注册和结果数据库,2005年9月30日之后,并更新为在2008年12月31日之前完成,允许在试验完成后至少30个月发表。主要结局指标生物医学文献中的发表和发表时间,通过Medline检索确定,结果截至2008年12月31日完成的635项临床试验中,294项(46%)在试验完成后30个月内发表在同行评议的生物医学期刊上,由Medline检索。试验完成后的中位随访期为51个月(第25 - 75百分位数40-68个月),共发表了432篇(68%)。在已发表的试验中,发表的中位时间为23个月(14-36个月)。与2007年之前完成的试验相比,2007年或2008年完成的试验更有可能在研究完成后30个月内发表(54%(196/366)vs36%(98/269); P
Objective To review patterns of publication of clinical trials funded by US National Institutes of Health (NIH) in peer reviewed biomedical journals indexed by Medline.Design Cross sectional analysis.Setting Clinical trials funded by NIH and registered within ClinicalTrials.gov (clinicaltrials.gov), a trial registry and results database maintained by the US National Library of Medicine, after 30 September 2005 and updated as having been completed by 31 December 2008, allowing at least 30 months for publication after completion of the trial.Main outcome measures Publication and time to publication in the biomedical literature, as determined through Medline searches, the last of which was performed in June 2011.Results Among 635 clinical trials completed by 31 December 2008, 294 (46%) were published in a peer reviewed biomedical journal, indexed by Medline, within 30 months of trial completion. The median period of follow-up after trial completion was 51 months (25th-75th centiles 40-68 months), and 432 (68%) were published overall. Among published trials, the median time to publication was 23 months (14-36 months). Trials completed in either 2007 or 2008 were more likely to be published within 30 months of study completion compared with trials completed before 2007 (54% (196/366) v 36% (98/269); P