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; Availability

摘要

The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled "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." Sponsors may encounter challenges in identifying methods to assess the numerous and heterogeneous Coronavirus Disease 2019 (COVID-19)-related symptoms across subjects when designing clinical trials of drugs to treat or prevent COVID-19 in adult and adolescent outpatient subjects. To assist sponsors, this guidance describes an example with a set of common COVID-19-related symptoms as well as an approach to their measurement for use in clinical trials. Given the public health emergency presented by COVID- 19, this guidance document is being implemented without prior public comment because FDA has determined that prior public participation is not feasible or appropriate, but it remains subject to comment in accordance with the Agency's good guidance practices.