新冠肺炎疫情影响下健康志愿者参与药物临床试验意愿调查

Investigation of Willingness of Healthy Volunteers to Participate in Drug Clinical Trials Under the Influence of COVID-19

目的了解健康志愿者在新冠肺炎疫情影响下参与药物临床试验的意愿,为药物临床试验的开展提供参考。方法通过线上问卷对18周岁以上的健康志愿者进行调查,运用SPSS 22.0进行描述性统计分析和交叉分析。结果回收有效问卷187份,愿意参加药物临床试验的健康志愿者占97.3%。大多数健康志愿者(74.3%)希望能在2020年4月参加试验,少数人(6.4%)希望在国内无新增病例、无境外输入病例的情况下参加。健康志愿者参加临床试验主要关注“试验补贴”(45.6%),但在性别因素上存在显著性差异,对于“试验地点是否在疫情高发区”(27.47%)和“新型冠状病毒感染的可能性”(19.23%)的关注度较低。在希望试验中心提供防护措施上,排名前3位分别是“佩戴口罩”(62.09%)、“体温监测”(53.85%)和“健康码”(51.56%)。结论在新冠肺炎疫情影响下,健康志愿者参加药物临床试验的积极性仍较高,但防护意识不足。各试验中心应积极做好防护措施,加强宣传教育,以保障广大志愿者的健康安全和试验项目的顺利开展。

OBJECTIVE To understand the willingness of healthy volunteers to participate in drug clinical trials under the influence of COVID-19 epidemic,so as to provide reference for the development of drug clinical trials.METHODS Healthy volunteers over 18 years old were investigated through online questionnaires,and descriptive statistical analysis and cross analysis were conducted by SPSS 22.0.RESULTS 187 valid questionnaires were collected,and 97.3%of the healthy volunteers were willing to participate in clinical trials.The majority of healthy volunteers(74.3%)wished to participate in the trial in April 2020,and a minority(6.4%)wished to participate in the trial without new domestic cases or imported cases from abroad.Participation of healthy volunteers in clinical trials focuses on"trial subsidy"(45.6%),but there were significant differences in gender factors.Healthy volunteers were less concerned about"whether drug trials are being carried out in areas where outbreaks are high"(27.47%)and"possibility of novel coronavirus infection"(19.23%).The top three protective measures that healthy volunteers expected the drug clinical trial center to provide were"wearing a mask"(62.09%),"temperature monitoring"(53.85%)and"health code"(51.56%).CONCLUSION Under the influence of COVID-19 epidemic,healthy volunteers were still highly motivated to participate in drug clinical trials,but lack of awareness of protection.In order to ensure the health and safety of the volunteers and the smooth development of the program,the clinical trial centers should take preventive measures and strengthen publicity and education.