《数据监查委员会在临床试验中的应用(草案)》[Use of Data Monitoring Committees in Clinical Trials,Guidance for Industry(draft guidance),以下简称“《草案》”]系美国FDA于2024年2月颁布的更新草案,旨在适应数据监查委员会(Data...《数据监查委员会在临床试验中的应用(草案)》[Use of Data Monitoring Committees in Clinical Trials,Guidance for Industry(draft guidance),以下简称“《草案》”]系美国FDA于2024年2月颁布的更新草案,旨在适应数据监查委员会(Data Monitoring Committee,DMC)自2006年指南颁布以来的发展需求。《草案》的更新主要针对DMC的组织结构和操作流程,在2006年指南的基础上重点完善了6项核心内容:适用范围扩展、创新临床试验设计整合、章程内容细化、全球化趋势、监查范围升级、职能扩大。本文基于DMC近20年的实践和发展历程,以六大更新点为核心展开对《草案》的系统解读与分析,以期帮助众多临床研究人员更好地理解并掌握《草案》,推动DMC在临床试验中的规范化应用,更有效地发挥其数据监查功能。展开更多
2025年,本专栏的2篇文章《无替代,何谈取消》[1]和《非动物实验替代知多少》[2]从宏观层面梳理了动物实验替代的现状、方法和适用范围,系统、全面地介绍了动物实验替代的法规、技术等内容。本期,我们将探讨目前美国食品药品监督管理局(F...2025年,本专栏的2篇文章《无替代,何谈取消》[1]和《非动物实验替代知多少》[2]从宏观层面梳理了动物实验替代的现状、方法和适用范围,系统、全面地介绍了动物实验替代的法规、技术等内容。本期,我们将探讨目前美国食品药品监督管理局(Food and Drug Administration,FDA)的新政策在推动非人灵长类(non-human primate,NHP)实验动物替代方面存在的局限性,通过对比分析,指出需在保持科学严谨性的同时兼顾动物福利,在二者之间找到平衡点,而非“完全替代”,才是更可行的路径。展开更多
Objective:Artemether is a semi-synthetic derivative of artemisinin and is widely used in the treatment of Plasmodium(P.)falciparum malaria.This study aimed to characterize the safety profile of artemether based on 15-...Objective:Artemether is a semi-synthetic derivative of artemisinin and is widely used in the treatment of Plasmodium(P.)falciparum malaria.This study aimed to characterize the safety profile of artemether based on 15-year data retrived from FDA adverse event reporting system(FAERS).Methods:This is a retrospective analysis on 15-year data of artemether-related adverse effects(AEs)retrieved from the FAERS.AEs were classified according to System Organ Class(SOC)and Preferred Terms(PT).Signal detection was performed using Reporting Odds Ratios(ROR),Proportional Reporting Ratios(PRR),and Empirical Bayes Geometric Mean(EBGM).Stratified analyses examined the impact of demographic factors such as sex,age,and time-to-onset.Temporal patterns and associated risk factors were also investigated.Results:Haemolytic anaemia and haemolysis emerged as the most frequently reported AEs,exhibiting significantly elevated RORs(males:ROR 381.36,95%CI 247.06-588.60;females:ROR 455.11,95%CI 286.43-723.12).Sex-specific differences were evident,with females showing a higher incidence of reproductive-related AEs,including spontaneous abortion and premature labour.Temporal trend analysis revealed that the majority of AEs occurred within the first 30 days after the initiation of artemether administration,indicating a rapid onset.The most affected SOCs were blood and lymphatic system disorders and hepatobiliary disorders.Conclusions:Artemether is associated with a notable frequency of early-onset AEs,particularly hematological and hepatobiliary disorders.The observed sex-specific vulnerability to reproductive AEs highlights the need for sex-conscious clinical approaches.Enhanced post-treatment monitoring and further investigations into the drug’s pharmacokinetics and mechanistic pathways are recommended.展开更多
文摘《数据监查委员会在临床试验中的应用(草案)》[Use of Data Monitoring Committees in Clinical Trials,Guidance for Industry(draft guidance),以下简称“《草案》”]系美国FDA于2024年2月颁布的更新草案,旨在适应数据监查委员会(Data Monitoring Committee,DMC)自2006年指南颁布以来的发展需求。《草案》的更新主要针对DMC的组织结构和操作流程,在2006年指南的基础上重点完善了6项核心内容:适用范围扩展、创新临床试验设计整合、章程内容细化、全球化趋势、监查范围升级、职能扩大。本文基于DMC近20年的实践和发展历程,以六大更新点为核心展开对《草案》的系统解读与分析,以期帮助众多临床研究人员更好地理解并掌握《草案》,推动DMC在临床试验中的规范化应用,更有效地发挥其数据监查功能。
文摘2025年,本专栏的2篇文章《无替代,何谈取消》[1]和《非动物实验替代知多少》[2]从宏观层面梳理了动物实验替代的现状、方法和适用范围,系统、全面地介绍了动物实验替代的法规、技术等内容。本期,我们将探讨目前美国食品药品监督管理局(Food and Drug Administration,FDA)的新政策在推动非人灵长类(non-human primate,NHP)实验动物替代方面存在的局限性,通过对比分析,指出需在保持科学严谨性的同时兼顾动物福利,在二者之间找到平衡点,而非“完全替代”,才是更可行的路径。
文摘Objective:Artemether is a semi-synthetic derivative of artemisinin and is widely used in the treatment of Plasmodium(P.)falciparum malaria.This study aimed to characterize the safety profile of artemether based on 15-year data retrived from FDA adverse event reporting system(FAERS).Methods:This is a retrospective analysis on 15-year data of artemether-related adverse effects(AEs)retrieved from the FAERS.AEs were classified according to System Organ Class(SOC)and Preferred Terms(PT).Signal detection was performed using Reporting Odds Ratios(ROR),Proportional Reporting Ratios(PRR),and Empirical Bayes Geometric Mean(EBGM).Stratified analyses examined the impact of demographic factors such as sex,age,and time-to-onset.Temporal patterns and associated risk factors were also investigated.Results:Haemolytic anaemia and haemolysis emerged as the most frequently reported AEs,exhibiting significantly elevated RORs(males:ROR 381.36,95%CI 247.06-588.60;females:ROR 455.11,95%CI 286.43-723.12).Sex-specific differences were evident,with females showing a higher incidence of reproductive-related AEs,including spontaneous abortion and premature labour.Temporal trend analysis revealed that the majority of AEs occurred within the first 30 days after the initiation of artemether administration,indicating a rapid onset.The most affected SOCs were blood and lymphatic system disorders and hepatobiliary disorders.Conclusions:Artemether is associated with a notable frequency of early-onset AEs,particularly hematological and hepatobiliary disorders.The observed sex-specific vulnerability to reproductive AEs highlights the need for sex-conscious clinical approaches.Enhanced post-treatment monitoring and further investigations into the drug’s pharmacokinetics and mechanistic pathways are recommended.
