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

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 impro...

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Autores principales: Ramdjee, Bruno, Husson, Mathilde, Hajage, David, Tubach, Florence, Estellat, Candice, Dechartres, Agnès
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Elsevier Inc. 2023
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10036148/
https://www.ncbi.nlm.nih.gov/pubmed/36965602
http://dx.doi.org/10.1016/j.jclinepi.2023.03.015
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author Ramdjee, Bruno
Husson, Mathilde
Hajage, David
Tubach, Florence
Estellat, Candice
Dechartres, Agnès
author_facet Ramdjee, Bruno
Husson, Mathilde
Hajage, David
Tubach, Florence
Estellat, Candice
Dechartres, Agnès
author_sort Ramdjee, Bruno
collection PubMed
description 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.
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spelling pubmed-100361482023-03-24 COVID-19 trials were not more likely to report intent to share individual data than non-COVID-19 trials in ClinicalTrials.gov Ramdjee, Bruno Husson, Mathilde Hajage, David Tubach, Florence Estellat, Candice Dechartres, Agnès J Clin Epidemiol Original Article 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. Elsevier Inc. 2023-06 2023-03-24 /pmc/articles/PMC10036148/ /pubmed/36965602 http://dx.doi.org/10.1016/j.jclinepi.2023.03.015 Text en © 2023 Elsevier Inc. All rights reserved. Since January 2020 Elsevier has created a COVID-19 resource centre with free information in English and Mandarin on the novel coronavirus COVID-19. The COVID-19 resource centre is hosted on Elsevier Connect, the company's public news and information website. Elsevier hereby grants permission to make all its COVID-19-related research that is available on the COVID-19 resource centre - including this research content - immediately available in PubMed Central and other publicly funded repositories, such as the WHO COVID database with rights for unrestricted research re-use and analyses in any form or by any means with acknowledgement of the original source. These permissions are granted for free by Elsevier for as long as the COVID-19 resource centre remains active.
spellingShingle Original Article
Ramdjee, Bruno
Husson, Mathilde
Hajage, David
Tubach, Florence
Estellat, Candice
Dechartres, Agnès
COVID-19 trials were not more likely to report intent to share individual data than non-COVID-19 trials in ClinicalTrials.gov
title COVID-19 trials were not more likely to report intent to share individual data than non-COVID-19 trials in ClinicalTrials.gov
title_full COVID-19 trials were not more likely to report intent to share individual data than non-COVID-19 trials in ClinicalTrials.gov
title_fullStr COVID-19 trials were not more likely to report intent to share individual data than non-COVID-19 trials in ClinicalTrials.gov
title_full_unstemmed COVID-19 trials were not more likely to report intent to share individual data than non-COVID-19 trials in ClinicalTrials.gov
title_short COVID-19 trials were not more likely to report intent to share individual data than non-COVID-19 trials in ClinicalTrials.gov
title_sort covid-19 trials were not more likely to report intent to share individual data than non-covid-19 trials in clinicaltrials.gov
topic Original Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10036148/
https://www.ncbi.nlm.nih.gov/pubmed/36965602
http://dx.doi.org/10.1016/j.jclinepi.2023.03.015
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