Characteristics, Motivations, and Preferences of Healthy Volunteers in Phase I Clinical Trials in Sweden.

IF 1.1 4区 哲学 Q2 ETHICS Journal of Empirical Research on Human Research Ethics Pub Date : 2025-02-01 Epub Date: 2025-01-27 DOI:10.1177/15562646241309142
Erik Rein-Hedin, Mårten Schultzberg, Folke Sjöberg, Fredrik Huss
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Abstract

This study examined the characteristics, experiences, motivations, and preferences of healthy volunteers participating in Phase I clinical trials in Sweden. A descriptive, cross-sectional survey was conducted among 135 healthy volunteers who had participated in at least one Phase I clinical trial from 2021 to 2024. Volunteers considered trial personnel, financial compensation, and regulatory review and approval as highly important factors in their decision to participate. Willingness to participate varied depending on trial characteristics, with greater reluctance for trials involving discomfort or perceived higher risks. Experiences, motivations, and preferences were comparable irrespective of age, gender, occupation, or income. Participants had disproportionately low incomes but reported financial satisfaction comparable to the general population. Unlike findings in other regions, there was no overrepresentation of migrants or the unemployed. Insights from this study can help guide trial design considerations to facilitate equitable recruitment and reduce the burden of participation.

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瑞典I期临床试验中健康志愿者的特征、动机和偏好
本研究考察了在瑞典参加一期临床试验的健康志愿者的特征、经历、动机和偏好。研究人员对135名健康志愿者进行了一项描述性横断面调查,这些志愿者在2021年至2024年期间至少参加了一项I期临床试验。志愿者认为,试验人员、经济补偿、监管审查和批准是他们决定参加试验的重要因素。受试者的参与意愿因试验特点而异,对于不舒服或风险较高的试验,受试者更不愿意参与。无论年龄、性别、职业或收入如何,经历、动机和偏好都具有可比性。参与者的收入低得不成比例,但报告的财务满意度与一般人群相当。与其他地区的调查结果不同,该地区的移民或失业人数并未过多。本研究的见解可以帮助指导试验设计考虑,以促进公平招募和减轻参与负担。
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来源期刊
CiteScore
3.50
自引率
7.70%
发文量
30
审稿时长
>12 weeks
期刊介绍: The Journal of Empirical Research on Human Research Ethics (JERHRE) is the only journal in the field of human research ethics dedicated exclusively to empirical research. Empirical knowledge translates ethical principles into procedures appropriate to specific cultures, contexts, and research topics. The journal''s distinguished editorial and advisory board brings a range of expertise and international perspective to provide high-quality double-blind peer-reviewed original articles.
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