Statistical Considerations for Clinical Trials During COVID-19: Accurate COVID-19 Testing in Clinical Trials

The World Health Organization (WHO) states that the Coronavirus Disease 2019 (COVID‑19) is caused by a new coronavirus strain of severe acute respiratory syndrome coronavirus‑2 (SARS‑CoV‑2). With such a large number of patients potentially carrying the virus clinical trial results can be affected whether or not a specific trial is for the development of a treatment of COVID-19 or other disease. The issue is that patients during the COVID-19 spread need to be classified by infection through either diagnostic test or antibody test. Due to lack of uniform standards, trials need to collect technical specifications such as sensitivity and specificity. The tests need to correctly measure the COVID-19 virus and have very high sensitivity and specificity; far above 80%.