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
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.
Food and Drug Administration(FDA)COVID-19drugclinical trialoutpatientsymptomassessmentguidance
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