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Why not? Motivations for entering a volunteer register for clinical trials during the COVID-19 pandemic

BACKGROUNDS: Healthy volunteers play a key role in clinical trials and it is crucial to develop recruitment strategies that capitalise on their motivations and maximise their participation. The COVID-19 pandemic has shown the importance of finding motivated healthy volunteers for the development of...

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Autores principales: Russo, Selena, Bani, Marco, Terraneo, Marco, Quaglia, Valeria, Nuvolati, Giampaolo, Cavaliere, Rebecca, Capici, Serena, Cazzaniga, Marina Elena, Strepparava, Maria Grazia
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Springer Berlin Heidelberg 2022
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9471028/
https://www.ncbi.nlm.nih.gov/pubmed/36102931
http://dx.doi.org/10.1007/s00228-022-03385-0
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author Russo, Selena
Bani, Marco
Terraneo, Marco
Quaglia, Valeria
Nuvolati, Giampaolo
Cavaliere, Rebecca
Capici, Serena
Cazzaniga, Marina Elena
Strepparava, Maria Grazia
author_facet Russo, Selena
Bani, Marco
Terraneo, Marco
Quaglia, Valeria
Nuvolati, Giampaolo
Cavaliere, Rebecca
Capici, Serena
Cazzaniga, Marina Elena
Strepparava, Maria Grazia
author_sort Russo, Selena
collection PubMed
description BACKGROUNDS: Healthy volunteers play a key role in clinical trials and it is crucial to develop recruitment strategies that capitalise on their motivations and maximise their participation. The COVID-19 pandemic has shown the importance of finding motivated healthy volunteers for the development of new vaccines. Public registers represent a promising way to promote the participation of healthy volunteers in the research field, but their adoption is still limited. The current study aimed to explore the motivations of healthy volunteers to enrol in an Italian public register for clinical trials during the COVID-19 pandemic and their attitude toward participating in a phase 1 COVID-19 vaccine clinical trial. The impacts of different enrolling interview modalities (in person, by phone, by mail) on motivation, understanding of information and trust in researchers were also investigated. METHODS: An online survey investigating experience with COVID-19, motivations to enrol, trust in researchers, political and healthcare authorities and pharmacological companies was presented to people applying as healthy volunteers in the public register for clinical trials at Phase 1 Unit Research Centre of ASST Monza, Italy, and considering to participate in a COVID-19 vaccine clinical trial. Data were collected in June 2021. RESULTS: Altruistic motivations were the main driver for enrolling in the public register, while self-interested motivations were secondary. No gender differences were found. As for enrolling modalities, no differences emerged between in-person and interviews for motivation to enrol, understanding of information and trust in researchers. Email modality led to significantly lower volunteers’ satisfaction and understanding of information but similar trust in research. CONCLUSIONS: This study supports the validity of different interview modalities (in person and by phone) for the enrolment of healthy volunteers for clinical trials and highlights the positive role of public registers for the recruitment procedures. SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1007/s00228-022-03385-0.
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spelling pubmed-94710282022-09-14 Why not? Motivations for entering a volunteer register for clinical trials during the COVID-19 pandemic Russo, Selena Bani, Marco Terraneo, Marco Quaglia, Valeria Nuvolati, Giampaolo Cavaliere, Rebecca Capici, Serena Cazzaniga, Marina Elena Strepparava, Maria Grazia Eur J Clin Pharmacol Clinical Trial BACKGROUNDS: Healthy volunteers play a key role in clinical trials and it is crucial to develop recruitment strategies that capitalise on their motivations and maximise their participation. The COVID-19 pandemic has shown the importance of finding motivated healthy volunteers for the development of new vaccines. Public registers represent a promising way to promote the participation of healthy volunteers in the research field, but their adoption is still limited. The current study aimed to explore the motivations of healthy volunteers to enrol in an Italian public register for clinical trials during the COVID-19 pandemic and their attitude toward participating in a phase 1 COVID-19 vaccine clinical trial. The impacts of different enrolling interview modalities (in person, by phone, by mail) on motivation, understanding of information and trust in researchers were also investigated. METHODS: An online survey investigating experience with COVID-19, motivations to enrol, trust in researchers, political and healthcare authorities and pharmacological companies was presented to people applying as healthy volunteers in the public register for clinical trials at Phase 1 Unit Research Centre of ASST Monza, Italy, and considering to participate in a COVID-19 vaccine clinical trial. Data were collected in June 2021. RESULTS: Altruistic motivations were the main driver for enrolling in the public register, while self-interested motivations were secondary. No gender differences were found. As for enrolling modalities, no differences emerged between in-person and interviews for motivation to enrol, understanding of information and trust in researchers. Email modality led to significantly lower volunteers’ satisfaction and understanding of information but similar trust in research. CONCLUSIONS: This study supports the validity of different interview modalities (in person and by phone) for the enrolment of healthy volunteers for clinical trials and highlights the positive role of public registers for the recruitment procedures. SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1007/s00228-022-03385-0. Springer Berlin Heidelberg 2022-09-14 2022 /pmc/articles/PMC9471028/ /pubmed/36102931 http://dx.doi.org/10.1007/s00228-022-03385-0 Text en © The Author(s) 2022 https://creativecommons.org/licenses/by/4.0/Open AccessThis article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/ (https://creativecommons.org/licenses/by/4.0/) .
spellingShingle Clinical Trial
Russo, Selena
Bani, Marco
Terraneo, Marco
Quaglia, Valeria
Nuvolati, Giampaolo
Cavaliere, Rebecca
Capici, Serena
Cazzaniga, Marina Elena
Strepparava, Maria Grazia
Why not? Motivations for entering a volunteer register for clinical trials during the COVID-19 pandemic
title Why not? Motivations for entering a volunteer register for clinical trials during the COVID-19 pandemic
title_full Why not? Motivations for entering a volunteer register for clinical trials during the COVID-19 pandemic
title_fullStr Why not? Motivations for entering a volunteer register for clinical trials during the COVID-19 pandemic
title_full_unstemmed Why not? Motivations for entering a volunteer register for clinical trials during the COVID-19 pandemic
title_short Why not? Motivations for entering a volunteer register for clinical trials during the COVID-19 pandemic
title_sort why not? motivations for entering a volunteer register for clinical trials during the covid-19 pandemic
topic Clinical Trial
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9471028/
https://www.ncbi.nlm.nih.gov/pubmed/36102931
http://dx.doi.org/10.1007/s00228-022-03385-0
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