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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...
Autores principales: | , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
Elsevier Inc.
2023
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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 |
Sumario: | 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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