受试者信息管理系统在生物等效性试验中的应用

Application of Subject Information Management System in Bioequivalence Test

随着我国化学仿制药一致性评价工作的快速推进,人体生物等效性试验的需求快速增加,各研究中心对受试者的需求也不断增加。准确的识别受试者身份信息,避免受试者短时间内、多中心重复参加试验,保证临床试验数据的真实性和科学性,是当前临床试验面临的问题之一。我院Ⅰ期临床研究中心生物等效性研究中应用的受试者信息管理系统,能实现对受试者参加临床试验项目的全过程进行管理。本文主要总结该系统的核心工具及主要功能,分析其在临床试验中的应用效果,旨在解决试验项目中健康受试者身份的真实性问题,以提高研究者的工作效率及临床试验质量。

With the rapid advancement of the consistency evaluation of chemical generic drugs in my country,the demand for human bioequivalence testing is rapidly increasing,and the demand for subjects in various research centers is also increasing.Accurately identifying subjects'identity information,avoiding subjects from repeatedly participating in trials in a short period of time and from multiple centers,and ensuring the authenticity and scientificity of clinical trial data are one of the current clinical trials facing problems.The subject information management system used in the bioequivalence study of the Phase I clinical research center of our hospital can manage the whole process of subjects participating in clinical trial projects.This article mainly summarizes the core tools and main functions of the system,analyzes its application effects in clinical trials,and aims to solve the authenticity of the identity of healthy subjects in the trial project,so as to improve the work efficiency of researchers and the quality of clinical trials.