大分子药物Ⅰ期临床试验风险的控制  

Risk control in phaseⅠclinical trials of macromolecular drugs

作　　者：白文静[1] 王娟 刘岳[1] 汪婷婷 王缇缇 王雅茹 殷钰莹 王欣[1] BAI Wen-jing;WANG Juan;LIU Yue;WANG Ting-ting;WANG Ti-ti;WANG Ya-ru;YIN Yu-ying;WANG Xin(Clinical Trial Center,Bejing Hospital/National Center of Gerontology/Institute of Geriatric Medicine,Chinese Academy of Medical Sciences,Beijing 100730,China)

机构地区：[1]北京医院国家老年医学中心中国医学科学院老年医学研究院临床试验研究中心,北京100730

出　　处：《中国临床药理学杂志》2024年第16期2424-2427,共4页The Chinese Journal of Clinical Pharmacology

摘　　要：通过对大分子药物Ⅰ期临床试验特点,大分子药物Ⅰ期临床试验评价指标的特点,如安全性评价方面、药代动力学以及药效学评价方面、疗效评价方面,以及大分子药物Ⅰ期临床试验风险管理控制实施中受试者管理方面、试验用大分子药物管理方面、大分子药物已识别的和潜在的风险因素三方面的控制要点,结合既往临床试验研究经验展开深入探讨。通过讨论分析,本课题组建议各研究中心能根据实际情况制定风险控制策略,提高风险管控效能,有利于临床试验的顺利实施,提高临床试验试验质量。The author analyzed the characteristics of phaseⅠclinical trials of macromolecular drugs,the characteristics of evaluation indicators of phaseⅠclinical trials of macromolecular drugs,such as safety evaluation,pharmacokinetic and pharmacodynamic evaluation,and efficacy evaluation.And the control points of subjects management,management of experimental macromolecule drugs,and identified and potential risk factors of macromolecule drugs in the implementation of risk management for phaseⅠclinical trials of macromolecule drugs were discussed in depth based on previous clinical trial research experience.Through discussion and analysis,the author suggests that each research center can formulate risk control strategies according to the actual situation,improve the efficiency of risk control,and facilitate the smooth implementation of clinical trials and improve the quality of clinical trials.

关 键 词：大分子药物 Ⅰ期临床试验 风险的控制 

分 类 号：R97[医药卫生—药品]