论文标题：Adherence to the International Committee of Medical Journal Editors’ (ICMJE) prospective registration policy and implications for outcome integrity: a cross-sectional analysis of trials published in high-impact specialty society journals

期刊：Trails

作者：Anand D. Gopal, Joshua D. Wallach, Jenerius A. Aminawung, Gregg Gonsalves, Rafael Dal-Ré, Jennifer E. Miller and Joseph S. Ross

发表时间：2018/08/23

数字识别码：10.1186/s13063-018-2825-y

原文链接：https://trialsjournal.biomedcentral.com/articles/10.1186/s13063-018-2825-y?utm_source=WeChat&utm_medium=Website_linksSocial_media_organic&utm_content=CelZha-MixedBrand-multijournal-Multidisciplinary-China&utm_campaign=ORG_AWA_CZH_BMCWechat_dailyposts_blogs

微信链接：https://mp.weixin.qq.com/s/HeWDO4Aev93vwfaYfGT7JQ

原文作者：Anand D. Gopal, Joshua D. Wallach, Jenerius A. Aminawung, Gregg Gonsalves, Rafael Dal-Ré, Jennifer E. Miller and Joseph S. Ross

前瞻性试验注册的目的在于发现和预防选择性报告和发表偏倚。 今天在Trials上发表的一项研究评估了10本高影响力专业医学团体期刊上发表的多个临床试验的注册情况，作者探讨了试验注册对医学领域发展的影响以及我们该如何解决回顾性注册可能带来的问题。

我们可能需要为期刊编辑和审稿人制定关于临床试验注册评估更详细的指南以促进科研透明。

为提高医学研究的完整性和透明度，前瞻性临床试验注册是大势所趋。临床试验普遍登记有助于发现和预防选择性（或歪曲）报告，包括未详细描述的试验修改和/或在已发表的研究中添加有利的（即统计学有意义的）的结果或去除不利结果。今天发表在Trials上发表的研究评估了10本高影响力专业医学团体期刊上发表的大量临床试验的注册情况。

2005年，国际医学期刊编辑委员会（ICMJE）采取了一项鼓励临床试验前瞻性注册的政策。ICMJE要求所有从2005年7月开始的临床试验必须在招募第一个患者时或招募前（即“前瞻性”）进行登记，这一条将作为在ICMJE成员期刊上发表研究的条件。尽管大部分期刊现在都参照ICMJE稿件发表指南，但有证据表明期刊编辑和出版商通常并不能坚持遵循前瞻性注册的政策。

曾有研究对高影响力综合医学期刊所发表试验的注册率进行评估，结果表明超过四分之一的已发表试验进行的是回顾性注册，这意味着研究人员可以更改研究设计和试验结果。

虽然现在因为多种举措的推出，临床研究注册和预说明已经变得越来越普遍，但大家对高影响力专业团体期刊上发表试验的注册情况仍知之甚少。这些期刊一般由专业组织（如美国神经病学协会（ANA）、美国肝病研究协会（AASLD））管理，通常体现其成员专家的观点。因此，专家们常常倾向于通过这些期刊了解临床试验和相关指南。

Trials最近发表的研究目的在于评估ICMJE前瞻性试验注册政策的遵循情况。作者想知道的是，有多少试验的注册时间过晚以致于研究人员已有机会对所收集的数据进行初步分析。此外，研究人员还分析了进行前瞻性注册的试验都具有哪些特征，以及注册和发表的主要结果之间的不同。

研究发现，2010年1月1日至2015年12月31日期间发表在10个影响力最大的美国专业医学团体期刊上的487项试验中，近10％未注册。这些试验中约有25％进行的是回顾性注册，其中大部分（68％）注册的时间比较晚，因而研究人员有机会在登记前对数据进行了初步分析。总体而言，未注册试验比注册试验更有可能报告有利结果。

期刊是这些研究结果最终的发表渠道，因此期刊在保证研究完整性中扮演了非常重要的角色。此外，专业团体期刊发表的研究通常可能对其目标临床读者产生重大影响。因此，这些期刊有责任确保充分且及时的临床试验注册以最大限度地减少结果报告偏差。

为改进现有系统，期刊编辑在评估临床试验投稿时需要进行更严格的审查。尽管期刊通常要求将公开试验注册信息作为同行评议过程的一部分，但研究表明，注册和报告材料之间的潜在差异不会影响稿件的录用。在一项对支持ICMJE指南的期刊编辑的调研中，大约三分之二的编辑表示会考虑发表回顾性注册的临床研究。

今后可能有必要为期刊编辑、审稿人和作者提供关于临床试验注册评估方面更详细的指导意见。例如：

1. 在投稿文章中，作者必须明确说明注册日期；如果是回顾性注册，也应明确说明。

2. 在同行评审过程中，编辑和/或审稿人应核查试验进行的前瞻性注册还是回顾性注册。

3. 在处理未注册或回顾性注册研究时，编辑和/或审稿人应特别注意结果的显著性（比如，只报告有利结果）。

4. 如果期刊最终决定要发表未注册或进行回顾性注册的试验，则应采取措施确保读者了解试验推迟注册的事实，比如在发表的文章中加入解释为何没有注册/延迟注册的声明。

5. 如果期刊最终决定要发表未注册或进行回顾性注册的试验，编辑应要求作者提供原始试验方案及其后续的修正。如果不能提供这些方案，那文章中应明确说明为什么无法获得这些材料。

也许这些措施有助于减少非标准临床试验前瞻性注册的潜在负面影响。总之，此项研究表明，更严格地遵循ICMJE试验前瞻性注册政策有助于提高临床研究的完整性和透明度。

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摘要：

Background

Registration of clinical trials is critical for promoting transparency and integrity in medical research; however, trials must be registered in a prospective fashion to deter unaccounted protocol modifications or selection of alternate outcomes that may enhance favorability of reported findings. We assessed adherence to the International Committee of Medical Journal Editors’ (ICMJE) prospective registration policy and identified the frequency of registrations occurring after potential observation of primary outcome data among trials published in the highest-impact journals associated with US professional medical societies. Additionally, we examined whether trials that are unregistered or registered after potential observation of primary outcome data were more likely to report favorable findings.

Methods

We conducted a retrospective, cross-sectional analysis of the 50 most recently published clinical trials that reported primary results in each of the ten highest-impact US medical specialty society journals between 1 January 2010 and 31 December 2015. We used descriptive statistics to characterize the proportions of trials that were: registered; registered retrospectively; registered retrospectively potentially after initial ascertainment of primary outcomes; and reporting favorable findings, overall and stratified by journal and trial characteristics. Chi-squared analyses were performed to assess differences in registration by journal and trial characteristics.

Results

We reviewed 6869 original research reports published between 1 January 2010 and 31 December 2015 to identify a total of 486 trials across 472 publications. Of these 486 trials, 47 (10%) were unregistered. Among 439 registered trials, 340 (77%) were registered prospectively and 99 (23%) retrospectively. Sixty-seven (68%) of these 99 retrospectively registered trials, or 15% of all 439 registered trials, were registered after potential observation of primary outcome data ascertained among participants enrolled at inception. Industry-funded trials, those with enrollment sites in the US, as well as those assessing FDA-regulated interventions each had lower rates of retrospective registration. Unregistered trials were more likely to report favorable findings than were registered trials (89% vs. 64%; relative risk (RR) = 1.38, 95% confidence interval (CI) = 1.20–1.58; p = 0.004), irrespective of registration timing.

Conclusions

Adherence to the ICMJE’s prospective registration policy remains sub-standard, even in the highest-impact journals associated with US professional medical societies. These journals frequently published unregistered trials and trials registered after potential observation of primary outcome data.

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https://trialsjournal.biomedcentral.com/articles/10.1186/s13063-018-2825-y?utm_source=WeChat&utm_medium=Website_linksSocial_media_organic&utm_content=CelZha-MixedBrand-multijournal-Multidisciplinary-China&utm_campaign=ORG_AWA_CZH_BMCWechat_dailyposts_blogs

期刊介绍:

Trials(https://trialsjournal.biomedcentral.com/, 2.067 - 2-year Impact Factor, 2.343 - 5-year Impact Factor) encompasses all aspects of the performance and findings of randomized controlled trials in health. We publish articles on general trial methodology and research into trial processes, as well as study protocols and statistical analysis plans for randomised controlled trials, commentaries and traditional results papers - regardless of outcome or significance of findings.

（来源：科学网）