患儿法定监护人对药物临床试验的认识、态度及关注点研究

Study on cognition, attitude, and focus of parents to clinical trials

为了解临床试验知情同意主要对象即患儿法定监护人对药物临床试验的认识、态度及关注点,以探讨儿童受试者保护方案和临床试验教育策略,提高儿童临床试验的参与度和依从性。通过分层随机抽样在某三甲儿童综合医院随机调查300位监护人,以住院病房为单位,每个病房随机抽取12张病床作为抽样床位,该床位住院患儿法定监护人即为调查对象,发现有较高受教育程度、较高家庭月收入以及听说过临床试验的监护人对临床试验的认识更好;受试者直接获益、受试者风险、受试者保护、经济利益是监护人的主要关注点,建议通过提高监护人认识、加强医患沟通和加强有效的伦理审查等保护受试者权益,促进儿童药物临床试验的合理开展。

To know parents＇ cognition, attitude and focus on clinical trials, to explore the protection plan of human subjects and education strategy, to encourage the participation and compliance of human subjects, a questionnaire was randomly surveyed in one children＇ s hospital. Twelve patients were choosing from each clinical department as the respondents. The results of questionnaire showed that parents who had a better education and higher incomes, knew clinical trials well or had heard of it, would have a better understanding. Parents mainly focused on human subjects＇ benefit, risks, protection and economic interests out of protection of children. To promote the rational development of clinical trials for children, investigators should designed strategies to improve parents＇ cognition, strengthen the communication between researchers and parents, and explain the protocols and ethical review strictly.