COVID-19’s Impact on Clinical Research

During the COVID-19 pandemic, federal and state restrictions hindered many aspects of clinical trials, such as recruiting patients, which made completing required research tasks difficult or impossible. Many existing guidance documents and policies were redesigned rapidly during the pandemic to accommodate COVID-19-related emergencies. Such policies laid the foundation for change in clinical research. The purpose of this clinical research regulatory review is to determine how regulatory bodies such as the Food and Drug Administration, Office of Human Research Protections, and institutional review boards have responded to challenges in running clinical trials during the COVID-19 pandemic.