山西省在校医学生对药物Ⅰ期临床试验认知现状及参与意愿调查

Survey on Cognition Status and Willingness to Participate in Phase Ⅰ Clinical Trials of Drugs among Medical Students in Shanxi Province

目的调查医学生对药物Ⅰ期临床试验的认知现状及参与意愿,为药物Ⅰ期临床试验开展提供指导。方法自编问卷对山西省某医学院校各年级学生抽样调查,结果进行统计分析。结果回收有效问卷732份,总知晓率86.6%,家庭医疗支出和年级影响知晓率高低。愿意参加试验的大学生共97名,占13.25%,主要动机是“为医学事业做贡献”(71.11%);388名学生拒绝参与试验,主要原因为“担心药物不安全”(84.02%);247名学生对是否参与试验表示犹豫不决,理由集中在“不了解药物风险和副作用,怕损害身体”(87.45%)。调查还显示,不论医学生对药物Ⅰ期试验持何种态度,家庭选项都是影响其决定的重要因素。结论医学生总体对于药物Ⅰ期临床试验认知较好,但参与意愿较低。药物安全和家庭因素是学生决策的重要角色。知情同意过程中重点解释药物不良反应及对策,同时应尽可能地与受试者家庭沟通,以获得支持。

Objective:To investigate the cognitive status and willingness of medical students to participate in phase Ⅰ clinical trials of drugs, so as to provide guidance for the development of phase Ⅰ clinical trials of drugs.Methods:A self-designed questionnaire was used to investigate the students of each grade in a medical college in Shanxi Province.Results:732 valid questionnaires were collected, the total awareness rate was 86.6%, and family medical expenditure and grade impacted the awareness rate. 97 college students(13.25%) were willing to participate in the experiment, and the main motivation was "to contribute to the medical cause"(71.11%).388 students refused to participate in the experiment, the main reason was "worried about drug insecurity"(84.02%). 247 students were hesitant to participate in the experiment, the reason was the lack of knowledge of drug risk and vice side effects(87.45%). The survey also showed that family choices were important factors in students who choose to participate or not. Conclusion:In general, medical students have a better understanding of phase I clinical trials, but a lower willingness to participate. Drug safety and family factors play an important role in students’ decision-making. In the process of informed consent, it is important to explain the adverse drug reactions and countermeasures, and at the same time, it is necessary to communicate with the subjects’ families as much as possible to obtain support.