Faculty of Life Sciences and Medicine, King's College London, London, UK.
Imperial College Healthcare NHS Trust, London, UK.
Int J Cardiol. 2017 Oct 1;244:309-315. doi: 10.1016/j.ijcard.2017.06.020. Epub 2017 Jun 7.
Appropriate dissemination of clinical data is crucial for minimising bias. Despite this, high rates of study discontinuation and non-publication have been reported among clinical trials. Cardiovascular medicine receives a substantial proportion of academic funding; however, predictors of non-publication among cardiovascular trials are not well-established.
The National Clinical Trials database was searched for cardiovascular trials completed between January 2010 and January 2014. Associated publications were identified in Medline or Embase. Relevant variables were extracted and subject to chi-squared and logistic regression to identify predictors of discontinuation and non-publication.
After reviewing 2035 trials, 431 trials were included, of which 82.1% (n=354; 119,233 participants) were completed. Among completed trials, 70.3% (n=249; 99,095 participants) were published. Industry funding was associated with increased likelihood of non-publication (odds ratio [OR] 2.84; 95% confidence interval [CI] 1.47-5.51; P=0.002), while non-randomised studies were more likely to remain unpublished than randomised counterparts. Industry-funded studies were over three times more likely to be discontinued than those sponsored by academic institutions (OR 3.89; CI 1.54-9.83; P=0.004). Trials studying heart failure and atrial fibrillation were more likely to be discontinued compared to trials studying coronary artery disease (OR 2.83; CI 1.23-6.51; and OR 3.10; CI 1.21-7.96, respectively). Of the total 135,714 participants, 25,565 were recruited into unpublished studies.
Discontinuation and non-publication of cardiovascular trials are common, resulting in data from thousands of participants remaining unpublished. Funding source and randomisation are strong predictors of non-publication, while sponsor type, phase and blinding status are key predictors of discontinuation.
适当传播临床数据对于最小化偏倚至关重要。尽管如此，临床试验中报告的研究中止和不发表率仍然很高。心血管医学获得了大量的学术资助；然而，心血管试验中不发表的预测因素尚未得到很好的确定。
在 2010 年 1 月至 2014 年 1 月期间，对国家临床试验数据库进行了搜索，以寻找已完成的心血管试验。在 Medline 或 Embase 中确定相关出版物。提取相关变量，并进行卡方检验和逻辑回归，以确定中止和不发表的预测因素。
在审查了 2035 项试验后，纳入了 431 项试验，其中 82.1%（n=354；119233 名参与者）完成。在已完成的试验中，70.3%（n=249；99095 名参与者）发表了论文。工业资助与不发表的可能性增加相关（优势比[OR]2.84；95%置信区间[CI]1.47-5.51；P=0.002），而非随机研究比随机研究更有可能未发表。工业资助的研究比由学术机构资助的研究更有可能被中止（OR3.89；CI1.54-9.83；P=0.004）。与研究冠状动脉疾病的试验相比，研究心力衰竭和心房颤动的试验更有可能被中止（OR2.83；CI1.23-6.51；和 OR3.10；CI1.21-7.96）。在总共 135714 名参与者中，有 25565 名参与者被纳入未发表的研究中。
心血管试验的中止和不发表很常见，导致数千名参与者的数据未发表。资金来源和随机化是不发表的有力预测因素，而资助类型、试验阶段和盲法状态是中止的关键预测因素。
