The Role of FDA CDER Statisticians in Response Efforts to the COVID-19 Pandemic

The current outbreak of respiratory disease is caused by a novel coronavirus. The virus has been named severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), and the disease it causes has been named coronavirus disease 2019 (COVID-19). On January 31, 2020, the Department of Health and Human Services (HHS) issued a declaration of a public health emergency related to COVID-19, effective January 27, 2020, and mobilized the Operating Divisions of HHS1. In addition, on March 13, 2020, the President of the United States declared a national emergency in response to COVID-192. The Food and Drug Administration (FDA), an HHS agency, plays a critical role in protecting the United States from threats such as emerging infectious diseases, including the COVID-19 pandemic. For example, FDA is committed to providing timely guidance to support responses to this pandemic. The Office of Biostatistics (OB) in the Center for Drug Evaluation and Research (CDER) has worked on numerous Guidances for Industry related to COVID-19, including four of particular interest to statisticians.