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Why an automated tracker finds poor sharing of clinical trial results for an academic sponsor: a bibliometric analysis
Scientometrics ( IF 3.9 ) Pub Date : 2021-01-04 , DOI: 10.1007/s11192-020-03775-0
E. Decullier , P. V. Tang , L. Huot , H. Maisonneuve

Objective: a Researchers have a duty to make the results of their research available publicly. According to the FDA, clinical trial data must be made public less than 12 months after the end of the trial. The trialstracker website (https://trialstracker.ebmdatalab.net/#/) ranks sponsors according to the proportion of unpublished clinical trials by extracting data from a prospective trial registry: clinicaltrials.gov. A low proportion of published trials could be explained by a failure to share results or the sponsor incorrectly filling out the clinicaltrials.gov database. The objective of this study was to assess for which of these reasons one academic sponsor was shown to have a high proportion of unpublished results. Methods: Bibliographic searches were performed and followed up with an email contact for the 104 HCL (Hospices Civils de Lyon, France) trials used by trialstracker to assess publication status. Results: Trialstracker considered that only 25 out of the 104 HCL trials had been published. By searching PubMed between February and April 2019, we rapidly identified publications for 27 further trials. A more advanced search and contact with the investigators allowed us to identify 24 more published trials. Overall, the proportion of trials published was 72.1% (n = 75) i.e. 3 times higher than the proportion provided by trialstracker. Even when restricted to the results found via a simple search, the proportion of publications was still higher with a two-fold increase. Conclusion: We found that trialstracker greatly underestimated the number of publications. All actors should therefore contribute to improving the visibility of clinical trial results by providing NCT numbers for all publications (investigator), and by updating clinicaltrials.gov (sponsor and investigator).



中文翻译:

为什么自动跟踪器发现学术赞助商的临床试验结果共享不佳:文献计量分析

目标:研究人员有责任公开其研究结果。根据FDA的规定,临床试验数据必须在试验结束后不到12个月内公开。teststracker网站(https://trialstracker.ebmdatalab.net/#/)通过从前瞻性试验注册中心中提取数据来根据未发表的临床试验的比例对申办者进行排序:未能发表结果或申办者错误地填写了Clinicaltrials.gov数据库,可能解释了已发表试验的比例低。这项研究的目的是评估出于何种原因,一个学术赞助商的未发表结果比例很高。方法:对书目进行了搜索,并随后通过电子邮件联系了104个HCL(Hospices Civils de Lyon,法国),triggertracker用于评估出版物状态的试验。结果:Trialstracker认为104项HCL试验中只有25项已经发表。通过在2019年2月至2019年4月之间搜索PubMed,我们迅速确定了27种进一步试验的出版物。通过更高级的搜索和与研究人员的联系,我们可以确定另外24项公开试验。总体而言,已发表试验的比例为72.1%(n  = 75),即比trialstracker提供的比例高3倍。即使仅限于通过简单搜索找到的结果,出版物的比例仍然更高,翻了两倍。结论:我们发现trialstracker大大低估了出版物的数量。因此,所有参与者都应通过提供所有出版物的NCT编号(研究者),以及更新Clinicaltrials.gov(赞助者和研究者),为提高临床试验结果的知名度做出贡献。

更新日期:2021-01-04
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