FDA的"在COVID-19预防或治疗药物和生物制品临床试验中,门诊成人和青少年受试者COVID-19相关症状评估的供企业用的指导原则"介绍
Introduction to FDA's Assessing COVID-19-Related Symptoms in Outpatient Adult and Adolescent Subjects in Clinical Trials of Drugs and Biological Products for COVID-19 Prevention or Treatment Guidance for Industry
萧惠来1
作者信息
- 1. 国家药品监督管理局药品审评中心,北京 100076
- 折叠
摘要
虽然新型冠状病毒肺炎(COVID-19)紧急状态已结束,但新型冠状病毒(SARS-CoV-2)还在继续传播,COVID-19对某些人来说仍然是严重的健康风险.为促进开发治疗和预防COVID-19的药物和生物制品,FDA于2024年2月发布了"在COVID-19预防或治疗药物和生物制品临床试验中,门诊成人和青少年受试者的COVID-19相关症状评估供企业用的指导原则".该指导原则讨论了这种门诊临床试验中,检测和分析COVID-19相关常见症状的方法,包括一般建议;主要症状的示例评估;试验终点选择;数据处理和其他相关的评估.而我国目前还没有类似的指导原则,详细介绍该指导原则,期望对我国这类研究和监管有启示.
Abstract
Although the COVID-19 emergency has ended,SARS-CoV-2 continues to circulate,and COVID-19 remains a serious health risk for some individuals.FDA issued the"Assessing COVID-19-Related Symptoms in Outpatient Adult and Adolescent Subjects in Clinical Trials of Drugs and Biological Products for COVID-19 Prevention or Treatment Guidance for Industry"in February 2024 to facilitate the development of drugs and biological products for the treatment and prevention of COVID-19.This guideline discusses the approaches for measurement and analysis of common symptoms associated with COVID-19 in this outpatient clinical trial,including general recommendations,example assessment of key symptoms,trial endpoint selection,handling data and additional related assessments.However,there is currently no similar guidance in China.This article provides a detailed introduction to this guidance,hoping to provide inspiration for research and regulation in this field in China.
关键词
美国食品药品管理局(FDA)/新型冠状病毒肺炎(COVID-19)/药物/临床试验/门诊患者/症状/评估/指导原则Key words
Food and Drug Administration(FDA)/COVID-19/drug/clinical trial/outpatient/symptom/assessment/guidance引用本文复制引用
出版年
2024
NETL
NSTL
万方数据