研究者发起的临床研究受试者招募现状及对策

doi:10.3969/j.issn.1000-8535.2023.11.002

广州医药 ›› 2023, Vol. 54 ›› Issue (11): 11-15.DOI: 10.3969/j.issn.1000-8535.2023.11.002

研究者发起的临床研究受试者招募现状及对策

周晓妮¹, 朱兆华¹, 阮光峰², 窦智燕¹, 梅凤娇¹, 刘雪莲¹, 黄程¹, 丁长海¹

1 南方医科大学珠江医院临床研究中心（广东广州 510282）
2 广州市第一人民医院/华南理工大学附属第二医院临床研究中心（广东广州 510180）

收稿日期:2023-07-24 出版日期:2023-11-20 发布日期:2023-12-12
通讯作者: 丁长海,E-mail：changhai.ding@utas.edu.au

Current status of recruitment of subjects and strategies in investigator-initiated trails

ZHOU Xiaoni¹, ZHU Zhaohua¹, RUAN Guangfeng², DOU Zhiyan¹, MEI Fengjiao¹, LIU Xuelian¹, HUANG Cheng¹, DING Changhai¹

1 Clinical Research Center,Zhujiang Hospital of Southern Medical University,Guangzhou 510282,China;
2 Clinical Research Center,Guangzhou First People's Hospital,the Second Affiliated Hospital of South China University of Technology,Guangzhou 510180,China

Received:2023-07-24 Online:2023-11-20 Published:2023-12-12

摘要/Abstract

摘要： 受试者招募工作关乎临床研究质量与进度。无法按计划招募到合适的受试者,一直是研究者发起的临床研究（IIT）开展过程中面临的主要挑战之一。本文分析影响IIT项目受试者招募进度的常见因素,并借鉴国内外经验,从提高受试者认知度与信任度、拓宽招募渠道、加强人文关怀、建立多中心伦理协作审查机制等方面探讨推进受试者招募的具体措施,以期为IIT研究者及科研管理部门提供参考。

关键词: 研究者发起的临床研究, 受试者招募, 受试者筛选, 协作审查

Abstract: Recruitment of subjects is crucial to the quality and progress of clinical research．However,the inability to recruit suitable subjects according to the plan has been one of the major challenges faced by investigators in the process of conducting investigator-initiated trial（IIT）．This article analyzes the common factors that affect the recruitment progress of IIT projects,draws on domestic and international experiences,and explores specific measures to promote subject recruitment,including improving subject awareness and trust,expanding recruitment channels,enhancing humanistic care and establishing a multi-center ethical collaboration review mechanism,in order to provide reference for IIT researchers and research management departments．

Key words: investigator-initiated trail, subject recruitment, subject screening, collaborative review

周晓妮, 朱兆华, 阮光峰, 窦智燕, 梅凤娇, 刘雪莲, 黄程, 丁长海. 研究者发起的临床研究受试者招募现状及对策[J]. 广州医药, 2023, 54(11): 11-15.

ZHOU Xiaoni, ZHU Zhaohua, RUAN Guangfeng, DOU Zhiyan, MEI Fengjiao, LIU Xuelian, HUANG Cheng, DING Changhai. Current status of recruitment of subjects and strategies in investigator-initiated trails[J]. Guangzhou Medical Journal, 2023, 54(11): 11-15.

参考文献

[1] 杨志敏,耿莹,高晨燕. 对研究者发起的临床研究的认识和思考[J].中国新药杂志,2014,23(4):387-390.
[2] 陈旻,莫楠.论研究者发起临床研究的伦理自律[J].中国医学伦理学,2017,30(5):563-566.
[3] 牟钰洁,韩梅,王丽琼,等.中医药临床试验受试者招募过程中的策略制定[J].评价思路与方法,2013,30(5):261-264.
[4] WONG C A,SONG W B,JIAO M,et al.Strategies for research participant engagement:A synthetic review and conceptual framework[J].Clinical Trials,2021,18(4):457-465.
[5] BLATCH-JONES A,NUTTALL J,BULL A,et al.Using digital tools in the recruitment and retention in randomised controlled trials:survey of UK Clinical Trial Units and a qualitative study[J].Trials,2020,21(1):304.
[6] 李树婷,郝鹏,毛冬蕾,等.我国新药临床试验受试者教育工作的现状和推进策略[J].中国新药杂志,2019,28(20):2524-2528.
[7] 徐岩,张晓方,李海燕,等.公众对临床研究认知的调查分析及培训方案探讨[J].中国新药杂志,2017,26(14):1618-1622.
[8] 莫恩盼,陈琳,杨忠奇.广东省药物临床试验的发展现状分析与探讨[J].中国新药与临床杂志,2020,39(2):79-83.
[9] SINE S,de BRUIN A,GETZ K.Patient engagement initiatives in clinical trials:Recent trends and implications.[J].Ther Innov Regul Sci,2021,55(5):1059-1065.
[10] COYLE J,ROGERS A,COPLAND R,et al.A secondary qualitative analysis of stakeholder views about participant recruitment,retention,and adherence in decentralised clinical trials(DCTs)[J].Trials,2022,23(1):614.
[11] 严康. 临床试验中影响受试者招募的因素分析[D].南京:南京中医药大学,2015.
[12] 董瑞华,李丹丹,梁宇光,等.对一项Ⅰ期临床试验健康受试者筛选失败原因的分析探讨[J].中国临床药理学杂志,2018,34(8):444-445.
[13] 王天琪,杨静雯,屠建锋,等.不同招募方式对针灸临床试验中受试者的影响与思考[J].现代中医临床,2019,26(1):58-61.
[14] 孔维嘉,陈佳祺,张楚浛,等.中医药临床试验受试者招募的影响因素分析[J].天津中医药大学学报,2020,39(1):59-66.
[15] 陈燕銮,甘彬,陈晓玲,等.受试者参加药物临床试验影响因素分析[J].中国公共卫生,2020,36(1):123-125.
[16] DUGAS M,LANGE M,MÜLLER-TIDOW C,et al.Routine data from hospital information systems can support patient recruitment for clinical studies[J].Clinical Trials,2010,7(2):183-189.
[17] 曹端文,薇白,孙文雄,等.一种基于医院信息管理系统的临床试验免费诊疗信息模块设计和应用[J].中国临床药理学杂志,2020,36(15):2365-2372.
[18] 姚晨,赵文乐.新型冠状病毒肺炎(COVID-19)临床研究的启示与国家临床试验网络构想[J].中国循证医学杂志,2020,20(5):497-503.
[19] 蒋璐灿,陈勇川.我国药物临床试验中心伦理审查的实践瓶颈与路径探析——2020版GCP相关规定的启示[J].医学与哲学,2020,41(15):20-24.
[20] 董冲亚,阎小妍,姚亮,等.规范多中心临床试验势在必行[J].中国循证医学杂志,2018,18(7):654-656.
[21] 戴国华,张伯礼,郭治昕,等.大样本多中心临床试验协作单位的选择[J].中国临床药理学与治疗学,2006,11(6):717-720.
[22] 严晋,刘瑜,钟筱华,等.效率与质量的平衡——构建多中心临床试验伦理审查协调体系与平台的设想[J].中国新药与临床杂志,2017,36(10):586-592.
[23] 于明坤. 受试者依从性影响因素和改善策略研究及在中医药肿瘤试验中的探索[D].北京:北京中医药大学,2021.
[24] ALNAAMANI K,ALSINANI S,BARKUN A N.Medical research during the COVID-19 pandemic[J].World J Clin Cases,2020,8(15):3156-3163.
[25] HOUGHTON C,DOWLING M,MESKELL P,et al.Factors that impact on recruitment to randomised trials in health care:a qualitative evidence synthesis[J].Cochrane Database Syst Rev,2020(10):MR45.
[26] TREWEEK S,PITKETHLY M,COOK J,et al.Strategies to improve recruitment to randomised trials[J].Cochrane Database Syst Rev,2018(2):MR000013.
[27] 李婷,刘相武,李欣,等.药物临床试验医院信息系统免费医嘱系统的应用[J].中国临床药理学杂志,2019,35(7):712-717.
[28] 何高丽,涛曾,炜张,等.药物临床试验受试者就诊“绿色通道”及信息化建设[J].中国新药与临床杂志,2019,38(6):340-343.
[29] 杜静,陈红君,余自成.基于医院信息系统的药物临床试验信息系统的构建[J].中国新药与临床杂志,2019,38(1):29-32.
[30] 陶军秀,李晓东,梁海莉,等.补肾祛邪方联合恩替卡韦治疗慢性乙型肝炎多中心临床研究中受试者临床依从性及其影响因素[J].中医杂志,2018,59(19):1661-1666.
[31] 曹烨,葛洁英,岑华芳,等.临床研究助理/研究护士角色定位、职责与管理模式[J].中国新药与临床杂志,2017,36(11):647-652.
[32] 叶苗苗,陈苑,许小慧,等.多中心临床试验伦理审查工作的开展及完善[J].中华医学科研管理杂志,2018,30(1):69-72.
[33] 黄旭,汪秀琴.关于多中心临床试验伦理协作审查的思考[J].中国新药杂志,2018,27(11):1290-1293.

研究者发起的临床研究受试者招募现状及对策

Current status of recruitment of subjects and strategies in investigator-initiated trails

PDF

可视化

摘要/Abstract

引用本文

使用本文

参考文献

相关文章 0

编辑推荐

Metrics

本文评价