背景:VACCELERATE泛欧科学网络旨在通过遵循公平原则来加强整个欧洲疫苗试验研究的基础,inclusion,和多样性。VACCELERATE志愿者注册网络提供对整个欧洲地区疫苗试验地点的访问,并支持可持续的志愿者平台,以确定即将进行的疫苗临床研究的潜在参与者。
目的:本研究的目的是与欧洲各地的患者倡导团体(PAG)成员联系,以评估他们注册VACCELERATE志愿者注册的意愿以及他们参与疫苗试验的观点。
方法:为了了解如何增加VACCELERATE志愿者注册的招募,用英语开发了一项标准化调查,并翻译成8种不同的语言(荷兰语,英语,法语,德语,希腊语,意大利语,西班牙语,和瑞典语)由各自的国家协调员小组负责。在网上,匿名调查被分发,从2022年3月到2022年5月,到10个欧洲国家的PAG(比利时,塞浦路斯,丹麦,法国,德国,希腊,爱尔兰,意大利,西班牙,和瑞典)与其成员分享。问卷由多项选择和开放式问题组成,评估参与者对参与疫苗试验的看法及其参与VACCELERATE志愿者注册的意愿。
结果:总计,收集和分析520个响应。PAG成员报告说,影响他们决定参与临床试验的主要标准是(1)所涉及的风险,(2)从他们的潜在参与中获得的利益,(3)提供的有关审判的信息的质量和数量。调查显示,在520名受访者中,所有年龄段的133个人对在VACCELERATE志愿者登记处注册表示“积极”,另有47人报告“非常积极”。来自北欧国家的受访者愿意参加VACCELERATE志愿者注册的可能性是南欧国家的1.725倍(95%CI1.206-2.468)。
结论:阻碍参与者加入疫苗试验注册或临床试验的因素主要包括对新型疫苗安全性的担忧以及对参与疫苗开发的参与者缺乏信任。这些结果有助于确定当前登记册中的问题和挫折,向VACCELERATE网络提供有关如何潜在地增加整个欧洲试验的参与和注册的反馈。在不同的公共社区中制定欧洲健康传播策略,尤其是通过PAG,是提高患者参与临床研究意愿的关键。
BACKGROUND: The VACCELERATE Pan-European Scientific network aims to strengthen the foundation of vaccine
trial research across Europe by following the principles of equity, inclusion, and diversity. The VACCELERATE Volunteer Registry network provides access to vaccine
trial sites across the European region and supports a sustainable volunteer platform for identifying potential participants for forthcoming vaccine clinical research.
OBJECTIVE: The aim of this
study was to approach members of patient advocacy groups (PAGs) across Europe to assess their willingness to register for the VACCELERATE Volunteer Registry and their perspectives related to participating in vaccine trials.
METHODS: In an effort to understand how to increase recruitment for the VACCELERATE Volunteer Registry, a standardized survey was developed in English and translated into 8 different languages (Dutch, English, French, German, Greek, Italian, Spanish, and Swedish) by the respective National Coordinator team. The online, anonymous survey was circulated, from March 2022 to May 2022, to PAGs across 10 European countries (Belgium, Cyprus, Denmark, France, Germany, Greece, Ireland, Italy, Spain, and Sweden) to share with their members. The questionnaire constituted of multiple choice and open-ended questions evaluating information regarding participants\' perceptions on participating in vaccine trials and their willingness to become involved in the VACCELERATE Volunteer Registry.
RESULTS: In total, 520 responses were collected and analyzed. The PAG members reported that the principal criteria influencing their decision to participate in clinical trials overall are (1) the risks involved, (2) the benefits that will be gained from their potential participation, and (3) the quality and quantity of information provided regarding the
trial. The survey revealed that, out of the 520 respondents, 133 individuals across all age groups were \"positive\" toward registering in the VACCELERATE Volunteer Registry, with an additional 47 individuals reporting being \"very positive.\" Respondents from Northern European countries were 1.725 (95% CI 1.206-2.468) times more likely to be willing to participate in the VACCELERATE Volunteer Registry than respondents from Southern European countries.
CONCLUSIONS: Factors discouraging participants from joining vaccine
trial registries or clinical trials primarily include concerns of the safety of novel vaccines and a lack of trust in those involved in vaccine development. These outcomes aid in identifying issues and setbacks in present registries, providing the VACCELERATE network with feedback on how to potentially increase participation and enrollment in trials across Europe. Development of European health communication strategies among diverse public communities, especially via PAGs, is the key for increasing patients\' willingness to participate in clinical studies.