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COVID-19 临床试验:在试验注册和发表时声明数据共享意向。

COVID-19 trials: declarations of data sharing intentions at trial registration and at publication.

机构信息

Vivli, Cambridge, USA.

Harvard, Center for Bioethics, Boston, MA, USA.

出版信息

Trials. 2021 Feb 18;22(1):153. doi: 10.1186/s13063-021-05104-z.

Abstract

BACKGROUND

The sharing of individual participant-level data from COVID-19 trials would allow re-use and secondary analysis that can help accelerate the identification of effective treatments. The sharing of trial data is not the norm, but the unprecedented pandemic caused by SARS-CoV-2 may serve as an impetus for greater data sharing. We sought to assess the data sharing intentions of interventional COVID-19 trials as declared in trial registrations and publications.

METHODS

We searched ClinicalTrials.gov and PubMed for COVID-19 interventional trials. We analyzed responses to ClinicalTrials.gov fields regarding intent to share individual participant level data and analyzed the data sharing statements in eligible publications.

RESULTS

Nine hundred twenty-four trial registrations were analyzed. 15.7% were willing to share, of which 38.6% were willing to share immediately upon publication of results. 47.6% declared they were not willing to share. Twenty-eight publications were analyzed representing 26 unique COVID-19 trials. Only seven publications contained data sharing statements; six indicated a willingness to share data whereas one indicated that data was not available for sharing.

CONCLUSIONS

At a time of pressing need for researchers to work together to combat a global pandemic, intent to share individual participant-level data from COVID-19 interventional trials is limited.

摘要

背景

分享 COVID-19 试验的个体参与者水平数据,可以进行再利用和二次分析,从而有助于加速确定有效治疗方法。但目前数据共享并不常见,不过由 SARS-CoV-2 引起的这场史无前例的大流行可能会成为推动数据共享的动力。我们试图评估在试验注册和出版物中声明的 COVID-19 干预性试验的数据共享意向。

方法

我们在 ClinicalTrials.gov 和 PubMed 上搜索 COVID-19 干预性试验。我们分析了 ClinicalTrials.gov 中关于是否打算分享个体参与者水平数据的字段的回复,并分析了符合条件的出版物中的数据共享声明。

结果

分析了 924 项试验注册,其中 15.7%的注册者愿意共享数据,其中 38.6%的注册者愿意在结果公布后立即共享。47.6%的注册者表示不愿意共享数据。分析了 28 篇出版物,这些出版物代表了 26 项独特的 COVID-19 试验。只有 7 篇出版物包含数据共享声明;其中 6 篇表示愿意共享数据,而 1 篇表示数据不可用。

结论

在迫切需要研究人员共同合作抗击全球大流行的情况下,COVID-19 干预性试验分享个体参与者水平数据的意愿有限。

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