Common problems and countermeasures in pediatric clinical trials of in vitro diagnostic reagents
10.3969/j.issn.1673-9701.2025.01.016
- VernacularTitle:体外诊断试剂临床试验在儿科开展的问题及对策
- Author:
Yi ZHOU
1
;
Sang ZHU
1
;
Pingfan LI
1
Author Information
1. 江南大学附属儿童医院(无锡市儿童医院)药物临床试验机构办公室,江苏 无锡 214023
- Publication Type:Journal Article
- Keywords:
Clinical trials of in vitro diagnostic reagent;
Children;
Common problems;
Countermeasures
- From:
China Modern Doctor
2025;63(1):67-70
- CountryChina
- Language:Chinese
-
Abstract:
Objective To grasp the common problems in the implementation of in vitro diagnostic reagent(IVD)clinical trials,and put forward countermeasures to improve the quality of IVD clinical trials.Methods Quality control reports of all IVD clinical trial projects in Wuxi Children's Hospital medical device clinical trial institutions since 2018 were collected,common problems were summarized,causes were analyzed,and solutions were proposed.Results Clinical trials of IVD have many problems in the following five aspects:ethical review,clinical trial preparation and program implementation,informed consent signing,biological sample and reagents management,and clinical trial records,some of which were related to the particularity of the subjects being children.The relevant regulatory system was not perfect,the sponsor's clinical trial concept was backward,the quality management system was incomplete,and investigators were lack of training and understaffed,the lack of quality control experience in the institutional office and the weak professional review ability of the ethics committee were the root causes of the problems.Conclusion Improve the construction of the regulatory system,strengthen the sponsor's awareness of the main responsibility to carry out clinical trials,improve the management system and standard operating procedures of sponsor and institutions,implement personnel training,improve the practical level of investigators,so as to improve the implementation level of IVD clinical trials,and promote the healthy development of IVD industry.
