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）。