A study on the prevalence and influencing factors of the willingness of healthy subjects to participate in clinical trials

一项关于健康受试者参与临床试验意愿的普遍性和影响因素的研究

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Abstract

OBJECTIVE: To investigate the willingness of healthy subjects to participate in clinical trials and its influencing factors, to improve recruitment efficiency. METHODS: A convenience sampling method was employed to conduct a questionnaire survey among healthy subjects using an online questionnaire system. Information on demographic characteristics, opinions on clinical trials, and willingness to participate in clinical trials was collected. Statistical description, along with univariate and multivariate unconditional logistic regression analyses, were used to evaluate the epidemiological characteristics of healthy subjects and the influence of related factors on their willingness to participate in clinical trials. RESULTS: A total of 423 valid questionnaires were collected. The average age of the healthy subjects was 29.13 ± 8.20 years old, with a gender ratio of 0.66:1. The willingness of healthy subjects to participate in clinical trials was 53.66% (227/423). Logistic regression analysis showed that urban subjects had higher willingness than rural subjects (OR = 2.175, 95% CI: 1.291-3.664). Unemployed individuals not actively seeking work subjects (OR = 2.891, 95% CI: 1.134-7.371) and those with a moderate level of understanding of clinical trials (OR = 3.906, 95% CI: 1.950-7.827) also showed higher willingness. In contrast, subjects who were aware of the functions of an ethics committee had lower willingness (OR = 0.565, 95% CI: 0.335-0.952). Factors such as age, gender, and average monthly income were not significantly associated. CONCLUSION: Residence, employment, and level of understanding of clinical trials significantly influence the willingness of healthy subjects to participate. Targeted strategies such as enhancing education in rural areas, optimizing recruitment among the unemployed individuals not actively seeking work, and improving ethical communication should be implemented to increase participation.

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