药物临床试验受试者入组速度的影响因素分析  

Influencing factors of enrollment speed in drug clinical trials

作　　者：陈诚 鲁晓雨 盛丽婷 虞燕霞[1] CHEN Cheng;LU Xiao-yu;SHENG Li-ting;YU Yan-xia(Clinical TrialsInstitution,Suzhou Municipal Hospital,The Affiliated Hospital of Nanjing Medical University,Suzhou 215002,Jiangsu Province,China)

机构地区：[1]苏州市立医院,南京医科大学附属苏州医院临床试验机构,江苏苏州215002

出　　处：《中国临床药理学杂志》2023年第17期2544-2547,共4页The Chinese Journal of Clinical Pharmacology

基　　金：苏州市科技发展计划基金资助项目(SLT2022020)。

摘　　要：目的 分析药物临床试验受试者入组速度的影响因素,从受试者、研究者和临床试验机构3个层面探讨改进策略,积极推进药物临床试验的开展。方法 对药物临床试验的相关人员进行问卷调研,内容包括参与药物临床试验的基本情况、临床试验难易程度评分、影响受试者招募困难的原因、提高受试者和研究者积极性的方法、医疗机构可以采取的措施等。结果 临床试验难易程度分值为6.28分;83.39%的调研人员认为受试者招募困难是影响临床试验入组进度的主要因素,进一步分析招募困难的原因是由于受试者对临床试验缺乏基本了解;73.42%的调研人员认为医院应该给予研究团队一定的经济和精神奖励来鼓励研究者积极参与临床试验;78.07%的调研人员同意医疗机构应该着重采取措施促进多院区和多科室互推受试者。结论 受试者入组速度是评价药物临床试验完成度的一个指标,可以通过建立多院区和社区联动体系、给予推荐人员奖励、对研究者人事职称聘任给予加分、积极做好项目宣传和受试者宣教工作等改进措施,提高受试者的入组速度,加快药物临床试验进度。Objective Analyze the influencing factors affecting the enrollment speed of subjects in drug clinical trials,explore the improvement strategies from the three levels of subjects,researchers and clinical trial institutions,so as to actively promote the development of drug clinical trials.Methods Investigate the relevant personnel in drug clinical trials,including the basic information of participating in trials,the difficulty score of clinical trials,the reasons for affecting the recruitment difficulties of subjects,the methods to improve the enthusiasm of subjects and researchers,and the measures that medical institutions can take.Results The clinical trial difficulty score was 6.28 points;83.39%believed that the difficulty in recruiting subjects was the main factor affecting the progress of clinical trials,further analyzed that the reason for the difficulty in recruiting subjects was the lack of basic understanding of clinical trials.73.42%believed that hospitals should give certain financial and spiritual rewards to research teams to encourage researchers to participate in clinical trials actively;78.07%of the respondents agreed that medical institutions should focus on taking measures to promote the mutual referral of subjects from multiple hospitals and departments.Conclusion The enrollment speed of subjects is an index to evaluate the completion of drug clinical trials.We can improve the enrollment speed of subjects and accelerate the progress of drug clinical trials by establishing a multi-hospital and community linkage system,giving rewards to recommenders,giving bonus points to researchers'personnel and professional titles,and actively doing project publicity and subject education.

关 键 词：药物临床试验 受试者 入组速度 项目管理 

分 类 号：R97[医药卫生—药品]