Delayed publication of clinical trials in cystic fibrosis.
Delayed publication of clinical trials in cystic fibrosis.
复制标题
DOI：
10.1016/j.jcf.2011.08.004
复制
发表时间：
2012-01
期刊：
影响因子：
--
通讯作者：
Smyth AR
中科院分区：
文献类型：
--
作者：
Hurley MN;Prayle AP;Smyth AR
当重要的试验数据的发表被延迟，或者数据从未被发表时，这将阻止通过强有力的系统性综述进行循证医学的适当实践。临床试验登记允许研究人员询问试验方案，并提供机会识别已完成的研究，从而确定完成和发表之间的时间差。我们用关键词“囊性纤维化”搜索了ClinicalTrials.gov。选择1998年1月1日至2010年12月31日完成的干预试验。计算了在同行评审期刊上发表的时间。使用对数秩检验进行生存分析。我们发现了142个记录。其中，62个国家有完整的纸质出版物。发表的中位时间为3.25年。研究阶段（I期研究更延迟，p = 0.024）但不是资金来源（p = 0.34）与发表时间相关。囊性纤维化的临床试验需要相当长的时间来报告他们的发现。更重要的是，大量审判根本没有报告。
When the publication of important trial data is delayed, or data are never published, this will prevent the proper practice of evidence based medicine through robust systematic reviews. Clinical trial registries allow researchers to interrogate the trial protocol and afford the opportunity to identify studies that have been completed and so determine the time lag between completion and publication. We searched ClinicalTrials.gov with the keywords ‘cystic fibrosis’. Intervention trials which had completed 1st Jan 1998–31st Dec 2010 were selected. Time to publication in a peer-reviewed journal was calculated. Survival analyses using the log rank test were undertaken. We identified 142 records. Of these, 62 had full paper publications. The median time to publication was 3.25 years. Phase of study (phase one studies more delayed, p = 0.024) but not source of funding (p = 0.34) was associated with time to publication. Clinical trials in cystic fibrosis take a considerable amount of time to report their findings. More importantly, a large number of trials fail to report at all.