COVID-19 trials were not more likely to report intent to share individual data than non-COVID-19 trials in ClinicalTrials.gov.
COVID-19
Clinical trials
Data sharing
Individual participant data
Intent to share
Registration
Journal
Journal of clinical epidemiology
ISSN: 1878-5921
Titre abrégé: J Clin Epidemiol
Pays: United States
ID NLM: 8801383
Informations de publication
Date de publication:
Jun 2023
Jun 2023
Historique:
received:
07
09
2022
revised:
30
01
2023
accepted:
21
03
2023
medline:
17
7
2023
pubmed:
26
3
2023
entrez:
25
3
2023
Statut:
ppublish
Résumé
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. 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). 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). Data-sharing intent at registration does not seem better for COVID-19 trials.
Identifiants
pubmed: 36965602
pii: S0895-4356(23)00066-5
doi: 10.1016/j.jclinepi.2023.03.015
pmc: PMC10036148
pii:
doi:
Types de publication
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
10-17Informations de copyright
Copyright © 2023 Elsevier Inc. All rights reserved.