研究者主导的药物临床试验招募实施  

Implementation of investigator-led drug clinical trial recruitment

作　　者：宋霞 阚婷婷 朱玲 陈佩玲 章海涛 SONG Xia;KAN Tingting;ZHU Ling;CHEN Peiling;ZHANG Haitao(National Clinical Research Center of Kidney Diseases,General Hospital of Eastern Theater Command PLA,Nanjing,Jiangsu 210016,China)

机构地区：[1]中国人民解放军东部战区总医院,国家肾脏疾病临床医学研究中心,江苏南京210016

出　　处：《中国临床研究》2024年第12期1940-1944,共5页Chinese Journal of Clinical Research

基　　金：国家重点研发计划课题(2021YFC2501302)。

摘　　要：目的以一项药物临床试验招募工作的实施为例,从研究者组织开展招募的视角,探讨研究者主导的药物临床试验招募的实施方法,以期为优化临床试验招募工作以及加强研究团队建设提供参考。方法2020年4月14日至2022年7月4日,东部战区总医院肾脏科开展了一项国际多中心Ⅲ期药物临床试验EMPA-KIDNEY研究,招募工作无第三方机构参与,均由研究者主导实施。研究通过开展“慢性肾脏病患者登记研究”储备患者、现场招募、医生推荐和数据库筛查等方式招募受试者,采取制定招募工作制度,明确成员职责提高团队效能,加强质控等措施进行招募管理。结果研究最终筛选受试者356例,单中心入组受试者305例,成功完成招募计划。其中,通过“登记研究”招募受试者196例,占EMPA项目入组人数的三分之二,其余患者来源于现场招募、门诊推荐和数据库筛查。尽管“登记研究”取得较好的招募效果,但门诊推荐的患者数量及入组成功率低于预期。结论相较于第三方招募团队,研究者对方案的理解和在入组标准的把控上更加专业,也更容易获得患者的信赖,对医院环境更为熟悉,因此在医院的招募实施中具有一定优势。研究者不应将职能完全转嫁给招募公司或者临床研究助理,应更多的参与到招募具体工作中发挥作用。临床试验招募受方案设计、团队组织架构、招募策略等多种因素影响,因此,建立高效的研究团队,选择适当的招募策略,加强招募管理对于招募实施十分重要。Objective Taking the implementation of recruitment for a drug clinical trial as an example,to discuss the implementation method of investigator-led recruitment for drug clinical trials from the perspective of the investigator's organization,with a view to providing a reference for optimizing the recruitment for clinical trials as well as strengthening the construction of the research team.Methods From April 14,2020 to July 4,2022,General Hospital of Eastern Theater Command conducted an international multicenter phase Ⅲ clinical trial for the EMPA-KIDNEY study,with no third-party involvement in the recruitment process,which was led by the investigator.The study recruited subjects from the Chronic Kidney Disease Patient Registry Study patient pool,on-site recruitment,physician referral,and database screening,and took measures such as developing a recruitment system,clarifying personnel responsibilities to improve team efficiency,and strengthening quality control to manage recruitment.Results A total of 356 subjects were screened and 305 subjects were enrolled in the study,successfully completing the recruitment plan.Among them,196 subjects were recruited through the“registration study”,accounting for two-thirds of the EMPA enrolment,while the rest of the patients were recruited on-site,referred by the clinic and screened by the database.“The enrolment study”achieved good recruitment results,but the number of outpatient referrals and the success rate of enrolment were lower than expected.Conclusion Compared to the third-party recruitment team,the investigators are more professional in their understanding of the protocol and in their control of the enrolment criteria,and are also more likely to gain the trust of the patients and be more familiar with the hospital environment,and therefore,have an advantage in the implementation of recruitment in hospitals.Researchers should not transfer their functions to recruiting companies or clinical research assistants,but should be more involved in the recruitment pro

关 键 词：临床试验 招募 招募策略 招募流程 研究者 

分 类 号：R95[医药卫生—药学]