注册型与非注册型药物临床试验研究模式管理的比较

Comparative study on the management of registered and non-registered clinical trials

注册型临床试验以药物临床试验为主,指在人体进行的药物系统性研究,以研究药物的安全性和有效性,是医疗学科发展的重要基础。非注册型的临床试验指由研究者发起的临床研究,不是以盈利或药品注册为目的,而是以学术或医疗保健目的为主,由医务人员发起,更加贴近患者的临床需求。本文从机构、伦理、研究者、申办者和临床监察员5个方面分析比较注册型与非注册型临床试验的管理模式,为我国临床试验管理体系构建提供参考。

Registered clinical trials are mainly drug clinical trials,which refer to the systematic research of drugs in humans to study the safety and effectiveness of drugs,which is an important foundation for the development of medical disciplines.Non-registered clinical trials are based on clinical research initiated by researchers,not for profit or drug registration,but for academic or medical care purposes,initiated by medical staff,and closer to the clinical needs of patients.This article analyzes and compares the management models of registered and unregistered clinical trials from five aspects:institutions,ethics,investigators,sponsors and clinical monitors,and provides references for the construction of my country’s clinical trial management system.