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Characteristics of clinical trials of influenza and respiratory syncytial virus registered in ClinicalTrials.gov between 2014 and 2021

The randomized clinical trial (RCT) is the ideal and mandatory type of study to verify the effect and safety of a drug. Our aim is to examine the fundamental characteristics of interventional clinical trials on influenza and respiratory syncytial virus (RSV). This is a cross-sectional study of RCTs...

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Autores principales: Lora, David, García-Reyne, Ana, Lalueza, Antonio, Maestro de la Calle, Guillermo, Ruíz-Ruigómez, María, Calderón, Enrique J., Menéndez-Orenga, Miguel
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Frontiers Media S.A. 2023
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10569070/
https://www.ncbi.nlm.nih.gov/pubmed/37841720
http://dx.doi.org/10.3389/fpubh.2023.1171975
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author Lora, David
García-Reyne, Ana
Lalueza, Antonio
Maestro de la Calle, Guillermo
Ruíz-Ruigómez, María
Calderón, Enrique J.
Menéndez-Orenga, Miguel
author_facet Lora, David
García-Reyne, Ana
Lalueza, Antonio
Maestro de la Calle, Guillermo
Ruíz-Ruigómez, María
Calderón, Enrique J.
Menéndez-Orenga, Miguel
author_sort Lora, David
collection PubMed
description The randomized clinical trial (RCT) is the ideal and mandatory type of study to verify the effect and safety of a drug. Our aim is to examine the fundamental characteristics of interventional clinical trials on influenza and respiratory syncytial virus (RSV). This is a cross-sectional study of RCTs on influenza and RSV in humans between 2014 and 2021 registered in ClinicalTrials.gov. A total of 516 studies were identified: 94 for RSV, 423 for influenza, and 1 for both viruses. There were 51 RCTs of RSV vaccines (54.3%) and 344 (81.3%) for influenza virus vaccines (p < 0.001). Twelve (12.8%) RCTs for RSV were conducted only with women, and 6 were conducted only with pregnant women; for RCTs for influenza, 4 (0.9%) and 3, respectively. For RSV, 29 (31%) of the RCTs were exclusive to people under 5 years of age, and 21 (5%) for influenza virus (p < 0.001). For RSV, there are no RCTs exclusively for people older than or equal to 65 years and no phase 4 trials. RCTs on influenza virus and RSV has focused on vaccines. For the influenza virus, research has been consolidated, and for RSV, research is still in the development phase and directed at children and pregnant women.
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spelling pubmed-105690702023-10-13 Characteristics of clinical trials of influenza and respiratory syncytial virus registered in ClinicalTrials.gov between 2014 and 2021 Lora, David García-Reyne, Ana Lalueza, Antonio Maestro de la Calle, Guillermo Ruíz-Ruigómez, María Calderón, Enrique J. Menéndez-Orenga, Miguel Front Public Health Public Health The randomized clinical trial (RCT) is the ideal and mandatory type of study to verify the effect and safety of a drug. Our aim is to examine the fundamental characteristics of interventional clinical trials on influenza and respiratory syncytial virus (RSV). This is a cross-sectional study of RCTs on influenza and RSV in humans between 2014 and 2021 registered in ClinicalTrials.gov. A total of 516 studies were identified: 94 for RSV, 423 for influenza, and 1 for both viruses. There were 51 RCTs of RSV vaccines (54.3%) and 344 (81.3%) for influenza virus vaccines (p < 0.001). Twelve (12.8%) RCTs for RSV were conducted only with women, and 6 were conducted only with pregnant women; for RCTs for influenza, 4 (0.9%) and 3, respectively. For RSV, 29 (31%) of the RCTs were exclusive to people under 5 years of age, and 21 (5%) for influenza virus (p < 0.001). For RSV, there are no RCTs exclusively for people older than or equal to 65 years and no phase 4 trials. RCTs on influenza virus and RSV has focused on vaccines. For the influenza virus, research has been consolidated, and for RSV, research is still in the development phase and directed at children and pregnant women. Frontiers Media S.A. 2023-09-28 /pmc/articles/PMC10569070/ /pubmed/37841720 http://dx.doi.org/10.3389/fpubh.2023.1171975 Text en Copyright © 2023 Lora, García-Reyne, Lalueza, Maestro de la Calle, Ruíz-Ruigómez, Calderón and Menéndez-Orenga. https://creativecommons.org/licenses/by/4.0/This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) and the copyright owner(s) are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.
spellingShingle Public Health
Lora, David
García-Reyne, Ana
Lalueza, Antonio
Maestro de la Calle, Guillermo
Ruíz-Ruigómez, María
Calderón, Enrique J.
Menéndez-Orenga, Miguel
Characteristics of clinical trials of influenza and respiratory syncytial virus registered in ClinicalTrials.gov between 2014 and 2021
title Characteristics of clinical trials of influenza and respiratory syncytial virus registered in ClinicalTrials.gov between 2014 and 2021
title_full Characteristics of clinical trials of influenza and respiratory syncytial virus registered in ClinicalTrials.gov between 2014 and 2021
title_fullStr Characteristics of clinical trials of influenza and respiratory syncytial virus registered in ClinicalTrials.gov between 2014 and 2021
title_full_unstemmed Characteristics of clinical trials of influenza and respiratory syncytial virus registered in ClinicalTrials.gov between 2014 and 2021
title_short Characteristics of clinical trials of influenza and respiratory syncytial virus registered in ClinicalTrials.gov between 2014 and 2021
title_sort characteristics of clinical trials of influenza and respiratory syncytial virus registered in clinicaltrials.gov between 2014 and 2021
topic Public Health
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10569070/
https://www.ncbi.nlm.nih.gov/pubmed/37841720
http://dx.doi.org/10.3389/fpubh.2023.1171975
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