药物临床试验中受试者风险最小化管理探讨

Minimization methods of subjects' risk management approach to drug clinical trials

目的:探讨在我国新药临床试验中进行受试者风险最小化管理的方法。方法:结合国内外相关临床试验风险管理条例以及对我国现行相关法规分析,分析目前临床试验风险、受试者权益、受试者风险分级管理等。结果:临床试验的高风险及不确定性使受试者常暴露于高风险中,严重程度与赔偿、治疗、不良事件报告等密切相关,等级大致可以划分为不大于最小风险、低风险、中等风险、高风险4个等级。可能受到的风险包括身体损害、心理危害、法律风险和经济危害。结论:应提高对临床试验的风险管理认识,当受试者承担的风险高于最小风险时,应采取措施降低风险等级保障受试者权益,特别是弱势群体。可通过提高风险认识水平,增强责任和防范意识、采取相应措施预防风险管理事件、减少事件可能发生的次数、风险转移或由涉及主体自行承担风险所造成的损失,来降低损害发生的可能性,或限制其严重程度或持续时间。

Objective： To explore the minimization methods of subjects＇ risk management approach to drug clinical trials. Methods： Referencing to foreign-related risk management regulations and China current laws on clinical trial risk, we analyzed the hierarchical management of risk, subjects＇ rights and benefits. Results ： Subjects participating in a study which has high-risk uncertainty exposed to a final potential risk. Identification and assess- ment of risks from physical harms, psychological harms, social and economic harms and rights of subjects are im- portant, and are used in guidelines for magnitude of harm in categorizing risk level. Clinical trials of high risk make the subject often exposed to high risk, and closely relate to the severity of the compensation, treatment and adverse event reports. Grades can generally be divided into 4 levels, namely no more than minimal risk, low risk, moderate risk, and high risk. Potential risks may include physical damage, psychological harm, legal risk and economic harm. Conclusion： People participating in clinical trials should raise awareness of the risk management when the risk of subjects is higher than the minimum risk that should take measures to reduce the risk to protect the benefits of the subjects, especially vulnerable groups. By increasing awareness of the risks, awareness of responsibility should be enhanced, and appropriate risk management measures should be taken to prevent incidents. These will reduce the number of events that may occur, risk transfer or risk of loss caused by the involved subject themselves, and the possibility of damage; or limit damage severity or duration.