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
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

10-17

Informations de copyright

Copyright © 2023 Elsevier Inc. All rights reserved.

Auteurs

Bruno Ramdjee (B)

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

Mathilde Husson (M)

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

David Hajage (D)

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.

Florence Tubach (F)

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.

Candice Estellat (C)

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.

Agnès Dechartres (A)

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. Electronic address: agnes.dechartres@aphp.fr.

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