摘要
目的探讨临床试验受试者招募工作中存在的问题及对策。方法基于一项中药辅助化疗治疗结肠癌的多中心临床试验,借鉴实施性研究方法思路,通过医院内招募和媒体招募两种措施,观察并记录受试者招募过程、分析影响招募效果的原因并提出改进建议。结果2019年9—11月共筛选246例患者。其中通过医院内招募筛选合格患者23例,最后入组9例;通过媒体招募3个月来电咨询的患者分别为118、47、58例,每月筛选合格患者分别为4、6、10例,最后入组0、0、1例。认为影响招募效果的因素可能有:严格的合格性标准、招募人员难确定、试验筛选表记录不及时、招募信息不详细、招募信息发放频次少、招募实施资源需求大、患者对参与临床试验的认知偏差。结论提高临床试验受试者招募效果应在医院内招募基础上结合媒体招募;招募信息应详略得当,对招募条件做出明确注释;要综合患者、医生、临床研究者的实际情况展开,丰富招募渠道。
Objective To explore the problems and countermeasures in the recruitment of clinical trial subjects.Methods Based on a multi-center clinical trial of traditional Chinese medicine adjuvant chemotherapy for the treatment of colon cancer,drawing on the idea of implementation research methods,through 2 measures of hospital recruitment and media recruitment,the recruitment process of subjects were observed and recorded,and the reasons that affected the recruitment were analyzed and improvements were proposed.Results From September to November 2019,a total of 246 patients were screened.Among them,23 qualified patients were recruited and screened through the hospitals,and 9 patients were finally enrolled.There were 118,47,and 58 patients were called for consultation in the three-month media recruitment,with 4,6,and 10 patients eligible for recruitment on a monthly basis,and finally 0,0,and 1 were enrolled.It was believed that the factors affecting the recruitment may include strict eligibility criteria,difficulty in determining recruiters,untimely record of the trial screening form,incomplete recruitment information,low frequency of recruitment information,high demand for recruitment and implementation resources,and the bias of patients′willingness to participate in clinical cognitive trials.Conclusion To improve the recruitment efficacy of clinical trial subjects,the media recruitment should be combined with the recruitment in the hospital;the recruitment information should be detailed and appropriate,and the recruitment conditions should be clearly explained;the actual situation of patients,doctors,and clinical researchers should be integrated to enrich the recruitment channel.
作者
文玲子
杨宇飞
许云
訾明杰
赵娜
闫蕴孜
闫韶花
刘建平
费宇彤
WEN Lingzi;YANG Yufei;XUYun;ZI Mingjie;ZHAO Na;YAN Yunzi;YAN Shaohua;LIU Jian-ping;FEI Yugtong(Centre for Evidence-Based Chinese Medicine,Beijing University of Chinese Medicine,Beijing,100029;Xiyuan Hospital,China Academy of Chinese Medical Sciences,Beijing;The Third Affiliated Hospital of Beijing University of Chinese Medicine;Beijing University of Chinese Medicine,Beijing)
出处
《中医杂志》
CSCD
北大核心
2020年第21期1888-1893,共6页
Journal of Traditional Chinese Medicine
基金
国家自然科学基金(81830115)
国家重点研发计划(2017YFC1700600,2017YFC1700604)。
关键词
临床试验方法
受试者招募
结肠癌
methodology of clinical trials
subject recruitment
colon cancer
