PDF(Pubmed)
Abstract：
Randomized controlled trials (RCTs) affect clinical decisions and their number is increasing. However, trends in international collaboration on RCTs and involvement of healthcare-related industries, the latter of which may contribute to bias, are not known. The objectives were to identify concerns surrounding RCTs, and to quantify changes in (1) the numbers of RCT articles in journals of high clinical importance, (2) international collaboration, and (3) commercial involvement in RCTs by authors in countries that contribute the most to the scientific literature. This was not a systematic review of the medical literature. It is a descriptive study of trends during the past two decades. We extracted RCT articles from MEDLINE data (1997-2019). When grouped by authors\' country, the analyses were limited to the 10 leading countries in the natural sciences, as defined by the Nature Index 2019 Annual Tables. The Core Clinical Journals (CCJ) filter in PubMed was used to identify journals that were likely to be highly relevant to clinical practice. RCT articles that included authors from multiple countries were used as examples of international collaboration, and RCTs in which at least one author\'s affiliation was corporate were considered to have commercial involvement. The annual number of RCT articles more than doubled (from 10,360 to 22,384), but the number published in the CCJ was essentially unchanged (from 2,245 to 2,346). The vast majority of RCT articles had US-based authors. International collaboration increased in nine of the 10 countries studied, and it was particularly common among researchers in Europe, Canada, and Australia. In contrast, international collaboration decreased in China. Regarding commercial involvement, between 1997 and 2019 the proportion of single-country RCTs with commercial involvement decreased (from 12.4% to 3.8% for the United States, and from 2.5% to 0.0% for Europe-Canada-Australia). In contrast, the proportion of international-collaborative RCTs with commercial involvement increased (from 9.2% to 17.6% for the United States, and from 17.9% to 21.3% for Europe-Canada-Australia). The largest change in commercial involvement was the 12-fold increase in Japan: from 3% to 36% (1997-2019). Japan was also noteworthy for its 28-percentage-point decrease in first-authorship of RCT articles from 2012 to 2019. In conclusion, recent increases in the number of RCT articles have occurred almost exclusively outside the CCJ. Thus, many newer RCT articles might have relatively low clinical relevance or impact. International collaboration has generally increased, along with commercial involvement. The latter has become particularly common in Japan, increasing the potential for sponsorship bias. The effects of ongoing attempts to reverse that trend should be evaluated.
摘要：
随机对照试验（RCT）影响临床决策，其数量正在增加。然而,RCT国际合作趋势和医疗保健相关行业的参与，后者可能会导致偏见，不知道。目标是确定围绕RCT的问题，并量化（1）高临床重要性期刊中RCT文章数量的变化，(2)国际合作,和（3）作者在对科学文献贡献最大的国家对RCT的商业参与。这不是对医学文献的系统回顾。这是对过去二十年趋势的描述性研究。我们从MEDLINE数据（1997-2019年）中提取了RCT文章。按作者国家/地区分组时，分析仅限于自然科学领域的10个主要国家，由自然指数2019年表定义。PubMed中的核心临床期刊（CCJ）过滤器用于识别可能与临床实践高度相关的期刊。包括来自多个国家的作者的RCT文章被用作国际合作的例子，至少有一位作者的从属关系是公司的RCT被认为有商业参与。RCT文章的年度数量增加了一倍以上（从10,360到22,384），但CCJ公布的数字基本没有变化(从2,245到2,346)。绝大多数RCT文章都有美国作者。在所研究的10个国家中，有9个国家的国际合作有所增加，这在欧洲的研究人员中尤其常见，加拿大,和澳大利亚。相比之下,中国的国际合作减少。关于商业参与，在1997年至2019年期间，具有商业参与的单一国家RCT的比例下降(美国从12.4%下降到3.8%，欧洲-加拿大-澳大利亚从2.5%到0.0%）。相比之下,具有商业参与的国际合作RCT的比例增加(美国从9.2%增加到17.6%，欧洲-加拿大-澳大利亚的比例从17.9%降至21.3%）。商业参与的最大变化是日本的12倍增长：从3％增加到36％（1997-2019）。日本也值得注意的是，从2012年到2019年，RCT文章的第一作者人数下降了28个百分点。总之,最近RCT文章数量的增加几乎完全发生在CCJ之外。因此，许多较新的RCT文章可能具有相对较低的临床相关性或影响.国际合作普遍增加，以及商业参与。后者在日本变得特别普遍，增加赞助偏见的可能性。应该评估正在进行的扭转这一趋势的努力的效果。
