背景:2019年冠状病毒病(COVID-19)大流行迫切需要进行临床试验,以发现安全有效的治疗方法。我们检查了COVID-19的经历,临床试验意识,对疫苗安全过程的信任与参与COVID-19临床试验的意愿相关。目的是调查在COVID-19大流行期间的18个月内,在四个不同的时间点,对联邦疫苗安全性监督的信任与参与COVID-19治疗临床试验的意愿之间的关系。
方法:我们使用了从2021年9月至2023年3月在582名费城居民中收集的四波数据(数据缺失率为0.9%)。广义估计方程估计了参与COVID-19临床试验的意愿与参与者对联邦政府监督COVID-19疫苗安全性的信任之间的关联,COVID-19相关变量(COVID-19相关健康挑战,COVID-19感染史),了解临床试验以及如何注册,和社会人口统计学特征(年龄,种族/民族,性取向,性别,父母身份,教育,和保险)。
结果:平均而言,参加COVID-19临床试验的意愿与联邦政府对疫苗安全性监督的更大信任呈正相关[β=0.34,95%置信区间(CI):0.15-0.53],患有COVID-19(β=0.40,95%CI:0.08-0.73),对临床试验的认识(β=0.38,95%CI:0.04-0.73),以及如何注册的知识(β=0.83,95%CI:0.44-1.23)。在社会人口统计学特征中,种族/民族(p=0.001)和性别(p=0.018)被确定为COVID-19试验意愿的预测因子。
结论:通过加强公众对联邦政府在疫苗安全监督中的作用的信任,可以增强参与临床试验的意愿,增加临床试验与个人健康和福祉的感知相关性,并提供量身定制的信息,以教育不同的社区关于正在进行的试验以及如何注册。
BACKGROUND: The Coronavirus Disease 2019 (COVID-19) pandemic precipitated an urgent need for clinical trials to discover safe and efficacious treatments. We examined how COVID-19 experiences, clinical trial awareness, and trust in the vaccine safety process were associated with willingness to participate in COVID-19 clinical trials. The objective was to investigate the relationship between trust in federal oversight of vaccine safety and willingness to participate in clinical trials for COVID-19 treatment across four distinct time points over an 18-month period during the COVID-19 pandemic.
METHODS: We used four waves of data collected from September 2021 to March 2023 among 582 Philadelphia residents (with a missing data rate of 0.9%). Generalized estimating equations estimated the association between willingness to participate in COVID-19 clinical trials and participants\' trust in the federal government\'s oversight of COVID-19 vaccine safety, COVID-19-related variables (COVID-19 related health challenges, history of COVID-19 infection), awareness of clinical trials and how to enroll in them, and sociodemographic characteristics (age, race/ethnicity, sexual orientation, gender, parental status, education, and insurance).
RESULTS: On average, willingness to participate in a COVID-19 clinical trial was positively associated with greater trust in the federal government\'s oversight of vaccine safety [β = 0.34, 95% confidence interval (CI): 0.15-0.53], having COVID-19 (β = 0.40, 95% CI: 0.08-0.73), awareness of clinical trials (β = 0.38, 95% CI: 0.04-0.73), and knowledge of how to enroll (β = 0.83, 95% CI: 0.44-1.23). Among sociodemographic characteristics, race/ethnicity (p = 0.001) and gender (p = 0.018) were identified as predictors for COVID-19 trial willingness.
CONCLUSIONS: Willingness to participate in clinical trials may be bolstered by strengthening the public\'s trust in the federal government\'s role within vaccine safety oversight, increasing the perceived relevance of clinical trials to individuals\' health and well-being, and offering tailored information to educate diverse communities about ongoing trials and how to enroll in them.