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预防疫苗试验的招募障碍:比利时的一项研究。

Recruitment barriers for prophylactic vaccine trials: A study in Belgium.

机构信息

GSK, Wavre, Belgium.

Centre for the Evaluation of Vaccination, Vaccine & Infectious Disease Institute, University of Antwerp, Belgium.

出版信息

Vaccine. 2017 Dec 4;35(48 Pt B):6598-6603. doi: 10.1016/j.vaccine.2017.10.041. Epub 2017 Oct 23.

DOI:10.1016/j.vaccine.2017.10.041
PMID:29074202
Abstract

Recruitment of volunteers is one of the main challenges in clinical trial management, and there is little information about recruitment barriers for preventative vaccine trials. We investigated both the recruitment barriers and recruitment strategies for preventive vaccine trials in Belgium. A 10 min survey was used as well as interviews of staff at all clinical trial sites in Belgium that regularly perform vaccine trials. We observed that there are successful recruitment strategies and few recruitment issues for trials involving healthy adults and those over 65 years old. However, challenges face the recruitment of paediatric populations, pregnant women, patients and the very elderly (over 85 years old). From these results, we identified three priority areas to increase recruitment for prophylactic vaccine trials in Belgium. These are: the lack of public knowledge about infectious diseases; the lack of resources of healthcare professionals to take part in clinical trials; and the burden to potential volunteers to take part in a trial. These were discussed with stakeholders and solutions were proposed.

摘要

志愿者招募是临床试验管理中的主要挑战之一,而对于预防性疫苗试验的招募障碍,相关信息却很少。我们调查了比利时预防疫苗试验的招募障碍和招募策略。使用了一份 10 分钟的调查问卷以及对所有定期进行疫苗试验的比利时临床试验点工作人员的访谈。我们观察到,对于涉及健康成年人和 65 岁以上老年人的试验,存在成功的招募策略和很少的招募问题。然而,对于儿科人群、孕妇、患者和非常高龄(85 岁以上)人群的招募却面临挑战。根据这些结果,我们确定了三个优先领域,以增加比利时预防性疫苗试验的招募。这些领域是:公众对传染病的认知度低;医疗保健专业人员参与临床试验的资源不足;以及潜在志愿者参与试验的负担。这些问题与利益相关者进行了讨论,并提出了解决方案。

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