监护人参与儿童药物临床试验的经历与知情同意认知度调研  

Investigation on Guardians’Cognition and Experience of Involvement in Pediatric Drug Clinical Trials

作　　者：李莉霞[1] 陆晓彤[1] Li Lixia;Lu Xiaotong(Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine,Shanghai 200092,China)

机构地区：[1]上海交通大学医学院附属新华医院,上海200092

出　　处：《儿科药学杂志》2021年第8期39-42,共4页Journal of Pediatric Pharmacy

基　　金：上海市科学技术委员会科研计划项目,编号17DZ1930402。

摘　　要：目的:了解监护人参与儿童药物临床试验的经历与知情同意认知度,为推进儿童药物临床试验开展提供参考。方法:选择2017年1-8月上海交通大学医学院附属新华医院、上海复旦大学附属儿科医院、上海交通大学附属儿童医院、哈尔滨儿童医院住院患儿的监护人,进行问卷调查。结果:回收有效问卷468份,仅有4.9%的监护人有参与儿童药物临床试验经历,6.4%的监护人有参与儿童药物临床试验意愿,小学学历监护人无参加意愿,52.1%的监护人需看情况,学历因素对监护人参与意愿的影响有统计学意义(P<0.01)。监护人愿意参与儿童药物临床试验的主要原因是疾病需要。73.1%的监护人认为,儿童需要了解并签署知情同意书。57.7%的监护人认为,12岁及以上儿童能够理解知情同意书内容,并可以签署知情同意书。结论:大部分监护人没有参加儿童药物临床试验的经历,不同学历的监护人对儿童药物临床试验的内容认识度及知情同意书的理解有差异。提高儿童药物临床试验的社会认知度,是保障儿童药物临床试验积极开展的重要条件。Objective:To investigate the guardians’experiences and cognition of involvement in pediatric drug clinical trials,so as to provide reference for promoting the development of pediatric drug clinical trials.Methods:Guardians of children hospitalized in Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine,Children’s Hospital of Fudan University,Children’s Hospital of Shanghai Jiaotong University and Harbin Children’s Hospital from Jan.to Aug.2017 were extracted for the questionnaire survey.Results:Totally 468 valid questionnaires were returned,and only 4.9%of the guardians had experience of involvement in pediatric drug clinical trials.And 6.4%of guardians had the willingness to participate in pediatric drug clinical trials,primary school-educated guardians had no willingness to participate,and 52.1%of the guardians depended on the situation,the influence of educational factors on guardians’willingness was statistically significant(P<0.01).The primary reason for guardians’willingness to participate in pediatric drug clinical trials was disease necessity.And 73.1%of guardians considered that children need to understand and sign the informed consent.And 57.7%of guardians considered that children aged 12 years and above were able to understand the content of the informed consent and could sign it.Conclusion:Most guardians had no experience of involvement in pediatric drug clinical trials,and there are differences in the degree of cognition of content of pediatric drug clinical trials and the understanding of informed consent among guardians with different education levels.The improvement of social cognition of pediatric drug clinical trials is the important factor to ensure the positive development of pediatric drug clinical trials.

关 键 词：药物临床试验 监护人 儿童 认知度 

分 类 号：R95[医药卫生—药学]