Challenges and suggestions for follow-up management of investigator initiated clinical trials under the normalization of COVID-19
10.3760/cma.j.cn113565-20210305-00044
- VernacularTitle: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
- Author:
Meirong WANG
1
;
Yao LU
;
Huijuan LI
Author Information
1. 北京大学临床研究所 100191
- Keywords:
Clinical study;
Follow-up management;
Current status;
Suggestions
- From:
Chinese Journal of Medical Science Research Management
2021;34(6):401-406
- CountryChina
- Language:Chinese
-
Abstract:
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.
