Publication bias in the medical literature: a review by a Canadian Research Ethics Board
Publication bias in the medical literature: a review by a Canadian Research Ethics Board
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DOI：
10.1007/bf03022661
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发表时间：
2007-05-01
期刊：
影响因子：
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通讯作者：
Webber, Adam
中科院分区：
文献类型：
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作者：
Hall, Richard;de Antueno, Cecilia;Webber, Adam
背景资料：我们审查了1995-1996年期间提交给新斯科舍省哈利法克斯的首都地区卫生当局研究伦理委员会（REB）的所有方案的出版记录。由于提高认识的问题，我们假设，将有较少的出版偏见（未能报告阴性结果）和较高的出版率，从已完成的研究，比以前reported.Methods：关闭的研究，确定从REB数据库。出版物由研究者、申办者要求和文献综述确定。对于每一篇出版物，我们确定了作者、标题、期刊、入组的受试者数量以及出版物是否为随机临床试验报告。比较使用学生的t检验，卡方统计量，或Fisher的精确检验酌情。结果：从数据库的封闭研究，106仍然未发表，而完成的调查导致84出版物（44%的出版率）。发表的中位时间为32.5个月。84项试验中有71项发表了具有统计学意义的结果。科室提交的方案发表率从91%（麻醉; 10/11）到25%（护理; 2/8（P < 0.05））不等。在3期或4期研究中研究新药的试验比在1期或2期研究药物的试验更有可能被发表（P < 0.05），并且如果由制药公司赞助，则不太可能被发表（P < 0.05）。我们的研究结果表明，需要一种不同的方法来减少发表偏倚。REB和同行评审期刊可能发挥的作用需要进一步探索。
Background: We reviewed the publication record of all protocols submitted to the Capital District Health Authority Research Ethics Board (REB) in Halifax, Nova Scotia, for the period 1995-1996. Because of a heightened awareness of the issue, we hypothesized that there would be less publication bias (a failure to report negative results) and a higher publication rate from completed studies, than previously reported.Methods: Closed studies were identified from the REB database. Publications were identified by the investigators, requests from sponsors, and a literature review. For each publication, we identified authors, title, journal, number of subjects enrolled, and whether or not the publication was a report of a randomized clinical trial. Comparisons were done using a Student's t test, the Chi-square statistic, or Fisher's exact test as appropriate.Results: From the database of closed studies, 106 remained unpublished, while completed investigations resulted in 84 publications (44% publication rate). The median time to publication was 32.5 months. Publication of statistically significant results occurred in 71/84 trials. Publication of protocols submitted by departments ranged from 91% (anesthesia; 10/11) to 25% [nursing; 2/8 (P < 0.05)]. Trials investigating new drugs in Phase 3 or 4 studies were more likely to be published than trials investigating agents in Phase 1 or 2 (P < 0.05), and were less likely to be published if sponsored by a pharmaceutical company (P < 0.05).Conclusions: Publication bias continues to be a problem, particularly for early phase investigative studies. Our results suggest that a different approach is required to reduce publication bias. The role that REBs and peer-reviewed journals might play requires further exploration.