雖然新型冠狀病毒肺炎 （COVID-19） 緊急狀態(tài)已結(jié)束 ， 但新型冠狀病毒 （SARS-CoV-2） 還在繼續(xù)傳播 ，COVID-19 對(duì)某些人來說仍然是嚴(yán)重的健康風(fēng)險(xiǎn)。為促進(jìn)開發(fā)治療和預(yù)防 COVID-19 的藥物和生物制品，F(xiàn)DA 于 2024 年 2 月發(fā)布了“在 COVID-19 預(yù)防或治療藥物和生物制品臨床試驗(yàn)中，門診成人和青少年受試者的 COVID-19 相關(guān)癥狀評(píng)估供企業(yè)用的指導(dǎo)原則”。該指導(dǎo)原則討論了這種門診臨床試驗(yàn)中，檢測(cè)和分析 COVID-19 相關(guān)常見癥狀的方法，包括一般建議；主要癥狀的示例評(píng)估；試驗(yàn)終點(diǎn)選擇；數(shù)據(jù)處理和其他相關(guān)的評(píng)估。而我國目前還沒有類似的指導(dǎo)原則，詳細(xì)介紹該指導(dǎo)原則，期望對(duì)我國這類研究和監(jiān)管有啟示。

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.

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