新冠肺炎疫情下抗肿瘤药物临床试验中受试者访视管理的紧急应对

Emergency Response of Subject Visiting Management in Clinical Trials of Anticancer Drugs During the Epidemic of COVID-19

目的结合当前新冠肺炎(COVID-19)疫情防控形势,优化受试者访视管理,保障药物临床试验中受试者权益,降低感染风险,确保临床试验的顺利进行。方法在COVID-19疫情防控期间,对我院受试者访视进行分类调研。根据常见不良事件评价标准(CTCAE)分级、试验药物特性、统计方判定不可缺失的关键访视及疫情防控要求,探讨受试者访视管理的紧急应对模式。结果抗肿瘤药物临床试验访视指引为:访视类别一至三就近就医,类别四至七返院就医(特殊情况无法返院,允许就近就医),类别八无需返院就医。访视类别一至三(A组)访视完成率90.70%,其中72.76%获得试验用药;访视类别四至七(B组)访视完成率89.30%,其中87.75%返院访视,未返院访视者中,53.26%获得试验用药;A、B两组访视完成率比较,差异无统计学意义(P>0.05);访视类别八访视完成率100%。通过访视管理,有效避免了失访,且未发生与疫情相关的不良事件。结论COVID-19疫情防控期间,对药物临床试验受试者的访视进行分类管理,既可达到疫情防控要求,又能有效保障受试者权益,保证临床试验的顺利开展。

Objective To optimize the subject visiting management to protect the rights of subjects in clinical trials,reduce the risk of infection and ensure the success of clinical trials in the current situation of COVID-19 epidemic prevention and control.Methods The subject visiting were classified and investigated in our hospital during the epidemic prevention and control period.In this study,the emergency response mode of subject visiting management was established based on the Common Terminology Criteria for Adverse Events Standard(CTCAE),the characteristics of trial drugs,the critical visits that cannot be missed and the requirements of epidemic prevention and control.Results The guidelines for clinical trial visiting of anti-tumor drugs are as follows:subjects in visiting class 1 to 3 go for nearby medical treatment.Those in visiting class to should return to the original hospital(in the special case that subjects are unable to return to the original hospital during the epidemic,they are allowed to go for nearby medical treatment).And those in visiting class are not required to hospital.In our study,90.0%subjects in visiting class 1 to 3(group A)completed their visits,of which 2.%received their trial drugs.In visiting class to(group B),9.30%subjects completed their visits,of which.%came to their original hospital.And 3.2%of subjects who did not visit the hospital also received their trial drugs.There were no statistical differences in the visits completion between group A and group B(P>0.0).Subjects in visiting class all completed their visits.No adverse events related to the COVID-19 occurred through the visiting management.Conclusion The visiting classification management not only met the requirements of epidemic prevention and control,but also effectively protected the rights and interests of subjects and ensured the successful development of the clinical trial.