2019冠状病毒病大流行期间个人参与者数据共享意图和做法:快速回顾

IF 1.8 Q3 PUBLIC ADMINISTRATION Data & policy Pub Date : 2023-08-15 DOI:10.1017/dap.2023.26
P. Kamath, Nachiket Gudi, C. Staunton, A. Jacob, Oommen John
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引用次数: 0

摘要

2019冠状病毒病(COVID-19)大流行导致临床用药不合理,缺乏临床管理指南。从临床试验中获取个体参与者数据(IPD)有助于证据合成方法。我们根据COVID-19背景下药物和疫苗试验的主要研究者(pi)的数据可用性声明进行了快速审查,以推断IPD共享意图。在PubMed (NCBI)上进行了搜索。我们纳入了2020年1月1日至2021年10月31日的随机对照试验(RCT)出版物。根据全文手稿出版物中的数据可用性声明推断IPD共享意图。我们纳入了180篇文章。其中,81.7%(147/180)的出版物来自单独的随机对照试验的结果,12.8%(23/180)的出版物是单独的方案出版物,5.6%(10/180)的随机对照试验同时发表了试验结果的方案和出版物。我们分别在RCT方案出版物(n = 23 + 10)和RCT结果出版物(n = 147 + 10)中报道了IPD共享意向。在RCT方案出版物中,三分之一(11/33)的pi打算共享IPD。事实上,在他们发表的RCT研究结果中,超过一半的pi(52.2%, 82/157)打算分享IPD。然而,57.6%(19/33)的RCT方案和38.2%(60/157)的已发表的RCT结果缺少关于IPD的信息共享。利益攸关方必须共同努力,确保精简管理临床试验实践的立法等首要因素,以加强IPD共享机制。
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Individual participant data sharing intentions and practices during the coronavirus disease-2019 pandemic: A rapid review
Abstract The coronavirus disease-2019 (COVID-19) pandemic has led to the irrational use of drugs in the absence of clinical management guidelines. Access to individual participant data (IPD) from clinical trials aids the evidence synthesis approaches. We undertook a rapid review to infer IPD sharing intentions based on data availability statements by the principal investigators (PIs) of drug and vaccine trials in the context of COVID-19. Searches were conducted on PubMed (NCBI). We considered randomized controlled trial (RCT) publications from January 1, 2020, to October 31, 2021. IPD sharing intentions were inferred based on the data availability statements in the full-text manuscript publications. We included 180 articles. Of these, 81.7% (147/180) of the publications have arrived from the findings of the RCTs alone, 12.8% (23/180) of the publications were protocol publications alone, and 5.6% (10/180) of the RCTs had both published protocol and publication from the trial findings. We have reported IPD sharing intentions separately in RCT protocol publications (n = 23 + 10) and publications from RCT findings (n = 147 + 10). Among RCT protocol publications, one-third (11/33) of the PIs intended to share IPD. In fact, over half of the PIs (52.2%, 82/157) in their published RCT findings intended to share IPD. However, information to share about IPD was missing for 57.6% (19/33) of RCT protocols and 38.2% (60/157) of published RCT findings. Stakeholders must work together to ensure that overarching factors, such as legislation that governs clinical trial practices, are streamlined to bolster IPD sharing mechanisms.
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CiteScore
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自引率
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审稿时长
12 weeks
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