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首页> 外文期刊>Journal of stroke and cerebrovascular diseases: The official journal of National Stroke Association >Reporting Compliance of Stroke Trials: Cross-Sectional Analysis
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Reporting Compliance of Stroke Trials: Cross-Sectional Analysis

机译：报告卒中试验的顺应性：横截面分析

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Background: The FDA mandates timely reporting of all clinical trials conducted in the United States. However, often the results are not reported in a timely manner, resulting in wastage of finite resources. We assessed the reporting of results of completed stroke trials and compared the reporting trends between U.S. and non U.S. stroke trials. Methods: We assessed consecutive clinical stroke trials registered as completed in ClinicalTrials. gov between January 1, 2008 and January 1, 2015. Descriptive data collected included study phase, study type, participant age, number of enrolled patients, study locations, start and primary completion dates, result availability, time to reporting (months), sponsorship, funding sources, and publication status. We also performed manual search for stroke trials in Pubmed, Web of Science, and Google scholar. Results: Out of a total 140 completed trials, 39 trials (35,359 patients) involved at least 1 U.S. center and 101 trials (58,542 patients) were conducted in non-U.S. centers. Of the trials involving at least a single U.S. center, 31 of 39 (79%) reported their results, whereas only 6 of 31 (19%) reported their results within 1 year. Of the trials conducted at non-U.S. centers, 72 of 101 (71%) reported their results, whereas results for 24 of 72 (33%) trials were available within a year of completion. The time to reporting of results was significantly lower for all the included clinical trials in the 2012-2014 period (P < .001, Cohen's d = .726) as compared to the 2008-2011 period. Conclusion: Only one fifth of completed stroke trials involving at least a single U.S. center report their results within 1 year. Additionally, every fifth completed trial involving stroke patients at U.S. centers remain unreported.
机译：背景：FDA授权及时报告美国在美国进行的所有临床试验。然而，通常不会及时报告结果，导致有限资源的浪费。我们评估了已完成的中风试验结果的报告，并比较了美国和非美国卒中试验之间的报告趋势。方法：我们评估了在临床上注册的连续临床中风试验。 Gov于2008年1月1日和2015年1月1日之间。收集的描述性数据包括研究阶段，学习类型，参与年龄，注册患者的数量，学习地点，开始和主要完成日期，结果可用性，报告时间（月份），赞助（月份） ，资金来源和出版状态。我们还在PubMed，Science，Science和Google Scholar中进行了手动搜索中风试验。结果：占140项完工试验，39名试验（35,359名患者）涉及至少1个美国和101名试验（58,542名患者）在非美国。涉及至少一个美国中心的试验，39名，共39名（79％）报告其结果，而仅有31个（19％）的6个（19％）在1年内报告其结果。在非美国的试验中进行的审判。101个（71％）的72名（71％）报告其结果，而在完成的一年内可获得72例（33％）试验中的24例的结果。与2008-2011期间相比，在2012-2014期间的所有临床试验中报告结果的时间明显降低了（P <.001，COHEN的D = .726）。结论：只有五分之一的完成中风试验，涉及至少一个美国中心在1年内报告其结果。此外，每个第五次完成的试验涉及美国中风患者的脑卒中患者仍未被报告。

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