Barriers and motivations for participation in preventive vaccine clinical trials: Experience of 5 clinical research sites

被引:22
作者
Detoc, M. [1 ,2 ,3 ]
Launay, O. [3 ,4 ,5 ]
Duale, C. [3 ,6 ]
Mutter, C. [3 ,7 ]
Le Huec, J-C [8 ]
Lenzi, N. [3 ]
Lucht, F. [1 ,2 ,3 ]
Gagneux-Brunon, A. [1 ,2 ,3 ]
Botelho-Nevers, E. [1 ,2 ,3 ]
机构
[1] Univ Hosp St Etienne, Clin Trial Ctr, INSERM CIC 1408, F-42055 St Etienne, France
[2] Univ Lyon, Med Sch St Etienne, GIMAP, EA3064, Lyon, France
[3] INSERM, F CRIN, Innovat Clin Res Network Vaccinol I REIVAC, Paris, France
[4] Univ Paris 05, Sorbonne Paris Cite, Paris, France
[5] Hop Cochin Broca Hotel Dieu, AP HP, INSERM, CIC Cochin Pasteur,CIC 1417, Paris, France
[6] CHU Clermont Ferrand, Ctr Pharmacol Clin INSERM CIC1405, Clermont Ferrand, France
[7] CHU Strasbourg, CIC Inserm 1434, Strasbourg, France
[8] Univ Bordeaux, Unite Rachis, Polyclin Bordeaux Nord Aquitaine, Deterca Lab, 15 Rue Boucher, F-33000 Bordeaux, France
关键词
Vaccine; Vaccine clinical trial; Motivations; Barriers; Participation; Recruitment; RANDOMIZED CONTROLLED-TRIALS; RECRUITMENT;
D O I
10.1016/j.vaccine.2019.09.048
中图分类号
R392 [医学免疫学]; Q939.91 [免疫学];
学科分类号
100102 ;
摘要
Recruitment in preventive vaccine trials (PVT) is challenging due to common barriers to clinical research and lack of vaccine confidence. Identifying determinants of participation can help to improve recruitment. A prospective survey was conducted in 5 French clinical investigational sites. People asked to participate in a PVT were given a questionnaire whether they decided to participate or not in the trial. A total of 341 people answered the survey: 210 accepting and 131 declining to participate in a PVT. Acceptors were significantly younger (38.5 vs 54.9 years old), more likely to be involved in early phase trials, had a higher level of education (p < 0.005) and a significantly better general opinion concerning vaccines (92.3% versus 72.3%, p < 0.005) compared with those who declined. Factors associated with acceptance or refusal were evaluated in 224 people in the 4 sites where both groups were included. In a multivariate analysis, three factors: older age, having heard about PVT through multiple sources and financial incentives were significantly associated with refusal to participate in the PVT. A generally favourable opinion of vaccines was associated with acceptance. The main motivation for participation was altruism (93.2%) whereas fear of side effects was at the forefront of the barriers (36.6%). Information given by the physician was a key point for decision-making in 70.2% of those who accepted. In brief, vaccine hesitancy may decrease recruitment in PVTs; reinforcing altruism and quality of information given are key points in acceptance of participation in PVT. (C) 2019 Published by Elsevier Ltd.
引用
收藏
页码:6633 / 6639
页数:7
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