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 fnding 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 feld, 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 diferent 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 diferences were found. As for enrolling modalities, no diferences emerged between in-person and interviews for motivation to enrol, understanding of information and trust in researchers. Email modality led to signifcantly lower volunteers’ satisfaction and understanding of information but similar trust in research. Conclusions This study supports the validity of diferent 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.
Russo, S., Bani, M., Terraneo, M., Quaglia, V., Nuvolati, G., Cavaliere, R., et al. (2022). Why not? Motivations for entering a volunteer register for clinical trials during the COVID-19 pandemic. EUROPEAN JOURNAL OF CLINICAL PHARMACOLOGY, 78, 1791-1800 [10.1007/s00228-022-03385-0].
Why not? Motivations for entering a volunteer register for clinical trials during the COVID-19 pandemic
Quaglia, V.;
2022
Abstract
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 fnding 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 feld, 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 diferent 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 diferences were found. As for enrolling modalities, no diferences emerged between in-person and interviews for motivation to enrol, understanding of information and trust in researchers. Email modality led to signifcantly lower volunteers’ satisfaction and understanding of information but similar trust in research. Conclusions This study supports the validity of diferent 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.| File | Dimensione | Formato | |
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Russo_Why-not-Motivations_2022.pdf
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Appendix 1 – Participants’ psycho-social COVID19-related variables.pdf
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