新型冠状病毒肺炎疫情常态化研究者发起的临床研究随访管理面临的挑战与建议  

Challenges and suggestions for follow-up management of investigator initiated clinical trials under the normalization of COVID-19

作　　者：王美容[1] 鲁尧 李会娟[1] Wang Meirong;Lu Yao;Li Huijuan(Peking University Clinical Research Institute,Beijing 100191,China)

机构地区：[1]北京大学临床研究所,100191

出　　处：《中华医学科研管理杂志》2021年第6期401-406,共6页Chinese Journal of Medical Science Research Management

摘　　要：目的提出新型冠状病毒肺炎疫情常态化下提高研究者发起的临床研究随访质量相关措施建议。方法通过结合相关文献与既往临床研究经验的方式,分析研究者发起的临床研究随访管理现状及新型冠状病毒肺炎疫情常态化研究者发起的临床研究随访管理面临的挑战。结果研究者发起的临床研究随访管理在随访内容、随访方式、随访人员和随访辅助工具等方面呈现多样性。研究经费相对不足及缺乏专业的临床研究团队支持,导致研究者发起的临床研究存在随访到访率低、随访人员不足、缺乏电子随访平台和随访时间窗不明等挑战,相关影响在疫情期间更为明显。结论新型冠状病毒肺炎疫情常态下,研究者发起的临床研究应根据研究疾病特点、主要研究终点、研究关键随访的关键指标内容、随访方式、随访频率和随访工具等方面进行多方论证,综合考虑研究的科学性和可行性,在遵循临床研究相关法律法规及伦理审查要求下修订研究方案随访管理内容,如调整随访内容、方式、模式、频率和时间窗,实施过程中重视知情同意过程的再次充分告知并严格按照调整后获批的研究方案执行,从而提高临床研究的随访质量。Objective Proposed suggestions to improve the quality of investigator-initiated trials follow-up management under the normalization of COVID-19.Methods Analyzed current status and challenges of follow-up management in China investigator initiated trial through a combination of literature review and previous work reflection,in the context of normalization of COVID-19.Results Follow-up management of investigator initiated trial had shown variations in follow-up contents,methods,personnel and auxiliary tools.The insufficient research funding and lacking of professional clinical research team support have led to the challenges of low follow-up visits,insufficient follow-up personnel,lack of electronic follow-up platforms,and unknown follow-up time windows for investigator-initiated trials,which became more prominent in the context of COVID-19.Conclusions In order to improve the quality of follow-up management during the normalization of COVID-19,appropriate amendment of the investigator-initiated trials follow up should be carefully considered.For instance,taking into account of the characteristics of the research disease,the main research endpoints,the content of the key indicators of the research key follow-up,follow-up methods,follow-up frequency,and follow-up tools to make sure the scientific validity and feasibility,as well as the mandate of clinical research related laws,regulations and ethical requirement.The possible amendments may include follow content,method,mode,frequency,time window.At the same time,re-consent or sufficient disclosure of information should be carried out with compliance of the updated protocols to assure the quality of clinical research follow up.

关 键 词：临床研究 随访管理 现状 建议 

分 类 号：R197.323[医药卫生—卫生事业管理]