Statistical Considerations for Clinical Trials During COVID-19: Background

The emergence of COVID-19 in a few weeks has posted various unprecedented challenges world-wide, including overwhelming stress on health care infrastructures of different countries. This also substantially affects current ongoing or near future clinical trials for drug development for various diseases, including cancer and other serious diseases, particularly where patients are immunocompromised. In response, the U.S. Food and Drug Administration (FDA) issued the guidance on Conduct of Clinical Trials of Medical Products during COVID-19 Pandemic. To mitigate challenges in conducting clinical trials during COVID-19, the FDA recognizes that protocol modifications may be required. Specifically, the guidance states...