FDA 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

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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[附网盘链接]是于之前发布的FDA标准，适用于US。

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标准文档类型为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[附网盘链接]高清PDF版本（文字版），标准文档内可进行搜索，可以复制原文，可粘贴。

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Contains Nonbinding Recommendations 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 1

Guidance for Industry This guidance represents the current thinking of the Food and Drug Administration (FDA or Agency) on this topic. It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations. To discuss an alternative approach, contact the FDA staff or Office responsible for this guidance as listed on the title page. I. INTRODUCTION FDA plays a critical role in protecting the United States from threats such as emerging infectious diseases, including the Coronavirus Disease 2019 (COVID-19) pandemic. FDA is committed to providing timely guidance to support response efforts to this pandemic. FDA is issuing this guidance to provide sponsors and investigators with considerations for approaches on how common COVID-19-related symptoms can be measured and analyzed in 2

clinical trials evaluating drugs or biological products for the prevention or treatment of COVID-

3 4

19 in outpatient adult and adolescent subjects. This guidance is not intended for development programs evaluating products to treat or prevent postinfectious COVID-19 conditions such as multisystem inflammatory syndrome in children or to development programs for preventative vaccines. This guidance does not address considerations for clinical trial design other than those pertaining to the measurement and analysis of COVID-19-related symptoms among outpatients. 1

This guidance has been prepared by the Office of New Drugs in the Center for Drug Evaluation and Research in cooperation with the Center for Biologics Evaluation and Research at the Food and Drug Administration. 2

For the purposes of this guidance, all references to drugs include both human drugs and biological products unless otherwise specified. 3

For the purposes of this guidance, adolescents are defined as 12 years of age to younger than 18 years of age. 4

Sponsors of clinical trials to evaluate drugs and biological products to treat or prevent COVID-19 should see the guidance for industry, investigators, and institutional review boards FDA Guidance on Conduct of Clinical Trials of Medical Products During COVID-19 Public Health Emergency (March 2020, updated July 2020) and the guidance for industry COVID-19: Developing Drugs and Biological Products for Treatment or Prevention (May 2020). We update guidances periodically. To make sure you have the most recent version of a guidance, check the FDA guidance web page at https://www.fda.gov/regulatory-information/search-fda-guidance-documents.

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