药物临床试验中受试者风险最小化管理探讨

发布时间：2018-02-14 13:28

本文关键词： 临床试验风险管理受试者权益风险分级风险最小化　出处：《中国新药杂志》2015年16期 　论文类型：期刊论文

【摘要】：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。
[Abstract]:Objective: to explore the methods of subject risk minimization in clinical trials of new drugs in China. Results: the high risk and uncertainty of clinical trials often exposed the subjects to high risks. The severity was closely related to compensation, treatment, adverse event reporting, etc. The grades can be roughly divided into four grades: no greater than the minimum risk, low risk, moderate risk, and high risk. Possible risks include physical damage, psychological harm, Conclusion: the risk management of clinical trials should be improved. When the risk taken by the subjects is higher than the minimum risk, measures should be taken to reduce the risk level and protect the rights and interests of the subjects. In particular, vulnerable groups... can take appropriate measures to prevent risk management events and reduce the number of possible incidents by raising the level of risk awareness, enhancing responsibility and awareness of prevention, Risk transfer or loss caused by the subject involved at his own risk to reduce the likelihood of damage or to limit its severity or duration.
【作者单位】：解放军总医院转化医学中心;
【基金】：国家“重大新药创制”科技重大专项子课题项目(2012ZX09303004-002)
【分类号】：R95

【共引文献】