Analysis of problems and management of in vitro diagnostic reagent clinical trials in medical laboratory
10.3760/cma.j.cn112150-20240408-00284
- VernacularTitle:医学检验实验室开展体外诊断试剂临床试验的问题与管理分析
- Author:
Yuhuan MAO
1
;
Tianran CAO
;
Lihua CHEN
;
Jinwei HU
;
Linying ZHOU
;
Qionghui MA
;
Xiaoyun SONG
;
Kun YUAN
Author Information
1. 中南大学湘雅医学院附属长沙医院（长沙市第一医院）检验科，长沙 410005
- Keywords:
In vitro diagnostic reagents;
Clinical trial;
Drug (Medical instrument) clinical trial institutions;
Medicine laboratory
- From:
Chinese Journal of Preventive Medicine
2024;58(9):1473-1477
- CountryChina
- Language:Chinese
-
Abstract:
Clinical trials are an important method for evaluating the safety and efficacy of in vitro diagnostic reagents, and are a key basis for product registration review and approval. In order to strengthen the management of clinical trials of in vitro diagnostic reagents, the National Medical Products Administration and relevant departments have formulated a series of regulations at the regulatory level, and require applicants and clinical trial institutions to establish a quality management system for clinical trials of in vitro diagnostic reagents. Medical laboratory is the main department and implementer of in vitro diagnostic reagent clinical trials in medical institutions. In recent years, with the rapid development of the in vitro diagnostic industry, the clinical trial projects of in vitro diagnostic reagents conducted by medical laboratory have been increasing day by day. However, there are currently few discussions on the clinical trial of in vitro diagnostic reagents from the perspective of researchers. Therefore, this article summarizes the characteristics of clinical trials of in vitro diagnostic reagents, analyzes the problems and difficulties in conducting clinical trials of in vitro diagnostic reagents in current medical laboratories, and introduces the laboratory′s experience in management; to provide reference for medical testing laboratories that have not yet conducted or have already conducted clinical trials of in vitro diagnostic reagents, in order to improve the quality and efficiency of clinical trials.
