• 文献检索
  • 文档翻译
  • 深度研究
  • 学术资讯
  • Suppr Zotero 插件Zotero 插件
  • 邀请有礼
  • 套餐&价格
  • 历史记录
应用&插件
Suppr Zotero 插件Zotero 插件浏览器插件Mac 客户端Windows 客户端微信小程序
定价
高级版会员购买积分包购买API积分包
服务
文献检索文档翻译深度研究API 文档MCP 服务
关于我们
关于 Suppr公司介绍联系我们用户协议隐私条款
关注我们

Suppr 超能文献

核心技术专利：CN118964589B侵权必究
粤ICP备2023148730 号-1Suppr @ 2026

文献检索

告别复杂PubMed语法，用中文像聊天一样搜索，搜遍4000万医学文献。AI智能推荐，让科研检索更轻松。

立即免费搜索

文件翻译

保留排版，准确专业，支持PDF/Word/PPT等文件格式，支持 12+语言互译。

免费翻译文档

深度研究

AI帮你快速写综述，25分钟生成高质量综述，智能提取关键信息，辅助科研写作。

立即免费体验

在 ClinicalTrials.gov 上，COVID-19 试验比非 COVID-19 试验更不可能报告分享个体数据的意向。

COVID-19 trials were not more likely to report intent to share individual data than non-COVID-19 trials in ClinicalTrials.gov.

机构信息

AP-HP, Hôpital Pitié Salpêtrière, Département de Santé Publique, F75013, Paris, France.

Sorbonne Université, INSERM, Institut Pierre Louis d'Epidémiologie et de Santé Publique, AP-HP, Hôpital Pitié Salpêtrière, Département de Santé Publique, CIC-1901, F75013, Paris, France.

出版信息

J Clin Epidemiol. 2023 Jun;158:10-17. doi: 10.1016/j.jclinepi.2023.03.015. Epub 2023 Mar 24.

DOI:10.1016/j.jclinepi.2023.03.015
PMID:36965602
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC10036148/
Abstract

OBJECTIVES

To compare intent to share individual participant data (IPD) between COVID-19 and non-COVID-19 trials registered at ClinicalTrials.gov between 01/09/2020, and 01/03/2021. We also evaluated factors independently associated with intent to share IPD and whether intent to share IPD has improved as compared with the prepandemic period.

METHODS

We searched ClinicalTrials.gov for all interventional phase 3 studies registered between 01/09/2020, and 01/03/2021. Then, we identified COVID-19 trials and selected a random sample of non-COVID-19 trials with a ratio 2:1. We compared the intent to share IPD between these trials and with 292 trials registered between 01/12/2019, and 01/03/2020 (prepandemic period).

RESULTS

We included 148 COVID-19 trials and 296 non-COVID-19 trials. Intent to share IPD did not significantly differ between COVID-19 and non-COVID-19 trials (22.3% vs. 27.0%, P = 0.3). Intent to share IPD was independently associated with industry-sponsorship (odds ratio [OR] = 2.92; 95% confidence interval [CI]: 1.65-5.27) and location in the United States (OR = 2.93; 95% CI: 1.64-5.41) or the European Union (OR = 2.06; 95% CI: 1.03-4.19). The intent to share IPD has not significantly improved compared with the prepandemic period (P = 0.16).

CONCLUSION

Data-sharing intent at registration does not seem better for COVID-19 trials.

摘要

目的

比较 2020 年 9 月 1 日至 2021 年 1 月 3 日期间在 ClinicalTrials.gov 注册的 COVID-19 试验和非 COVID-19 试验之间分享个体参与者数据（IPD）的意向。我们还评估了与分享 IPD 的意向独立相关的因素，以及与大流行前相比，分享 IPD 的意向是否有所改善。

方法

我们在 ClinicalTrials.gov 上搜索了所有在 2020 年 9 月 1 日至 2021 年 1 月 3 日期间注册的干预性 3 期研究。然后，我们确定了 COVID-19 试验，并随机选择了一组与 COVID-19 试验比例为 2:1 的非 COVID-19 试验。我们比较了这些试验与 2019 年 12 月 12 日至 2020 年 1 月 3 日（大流行前）期间注册的 292 个试验之间分享 IPD 的意向。

结果

我们纳入了 148 项 COVID-19 试验和 296 项非 COVID-19 试验。COVID-19 试验和非 COVID-19 试验之间分享 IPD 的意向没有显著差异（22.3%与 27.0%，P=0.3）。分享 IPD 的意向与工业赞助（优势比[OR]为 2.92；95%置信区间[CI]：1.65-5.27）和试验地点在美国（OR=2.93；95%CI：1.64-5.41）或欧盟（OR=2.06；95%CI：1.03-4.19）独立相关。与大流行前相比，分享 IPD 的意向并没有显著改善（P=0.16）。

结论

注册时的数据共享意向似乎并没有因 COVID-19 试验而变得更好。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/ea0f/10036148/b3a2f59572b4/gr3_lrg.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/ea0f/10036148/ef3054072a7f/gr1_lrg.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/ea0f/10036148/1441301847c6/gr2_lrg.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/ea0f/10036148/b3a2f59572b4/gr3_lrg.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/ea0f/10036148/ef3054072a7f/gr1_lrg.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/ea0f/10036148/1441301847c6/gr2_lrg.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/ea0f/10036148/b3a2f59572b4/gr3_lrg.jpg

相似文献

1
COVID-19 trials were not more likely to report intent to share individual data than non-COVID-19 trials in ClinicalTrials.gov.在 ClinicalTrials.gov 上，COVID-19 试验比非 COVID-19 试验更不可能报告分享个体数据的意向。
J Clin Epidemiol. 2023 Jun;158:10-17. doi: 10.1016/j.jclinepi.2023.03.015. Epub 2023 Mar 24.
2
COVID-19 interventional trials: Analysis of data sharing intentions during a time of pandemic.COVID-19干预试验：大流行期间数据共享意图分析
Contemp Clin Trials. 2022 Apr;115:106709. doi: 10.1016/j.cct.2022.106709. Epub 2022 Feb 16.
3
Breaking the silence of sharing data in medical research.打破医学研究中数据共享的沉默。
PLoS One. 2024 May 29;19(5):e0301917. doi: 10.1371/journal.pone.0301917. eCollection 2024.
4
Primed to comply: Individual participant data sharing statements on ClinicalTrials.gov.准备遵守：ClinicalTrials.gov 上的个体参与者数据共享声明。
PLoS One. 2020 Feb 18;15(2):e0226143. doi: 10.1371/journal.pone.0226143. eCollection 2020.
5
COVID-19 trials: declarations of data sharing intentions at trial registration and at publication.COVID-19 临床试验：在试验注册和发表时声明数据共享意向。
Trials. 2021 Feb 18;22(1):153. doi: 10.1186/s13063-021-05104-z.
6
Sharing of Individual Participant Data from Clinical Trials: General Comparison and HIV Use Case.临床试验中个体参与者数据的共享：总体比较与艾滋病病毒用例
AMIA Annu Symp Proc. 2020 Mar 4;2019:647-654. eCollection 2019.
7
Evaluating the discoverability of supporting research materials in ClinicalTrials.gov for US federally funded COVID-19 clinical studies.评估 ClinicalTrials.gov 中美国联邦资助的 COVID-19 临床研究支持研究材料的可发现性。
J Med Libr Assoc. 2024 Jul 1;112(3):250-260. doi: 10.5195/jmla.2024.1799. Epub 2024 Jul 29.
8
Updating insights into rosiglitazone and cardiovascular risk through shared data: individual patient and summary level meta-analyses.通过共享数据更新罗格列酮与心血管风险的认识：个体患者和汇总水平荟萃分析。
BMJ. 2020 Feb 5;368:l7078. doi: 10.1136/bmj.l7078.
9
To share or not to share data: how valid are trials evaluating first-line ovulation induction for polycystic ovary syndrome?数据共享与否：评估多囊卵巢综合征一线促排卵治疗的试验有多可靠？
Hum Reprod Update. 2020 Nov 1;26(6):929-941. doi: 10.1093/humupd/dmaa031.
10
Availability of Clinical Trial Data From Industry-Sponsored Cardiovascular Trials.行业资助的心血管试验的临床试验数据可用性。
J Am Heart Assoc. 2016 Apr 20;5(4):e003307. doi: 10.1161/JAHA.116.003307.

引用本文的文献

1
Practice of data sharing plans in clinical trial registrations and concordance between registered and published data sharing plans: a cross-sectional study.临床试验注册中数据共享计划的实施情况以及注册数据共享计划与发表数据共享计划之间的一致性：一项横断面研究。
BMC Med. 2025 Sep 1;23(1):510. doi: 10.1186/s12916-025-04328-z.
2
Data-Sharing Statements Requested from Clinical Trials by Public, Environmental, and Occupational Health Journals: Cross-Sectional Study.公共卫生、环境与职业健康期刊要求临床试验提供的数据共享声明：横断面研究
J Med Internet Res. 2025 Feb 7;27:e64069. doi: 10.2196/64069.