The Food and Drug Administration (FDA) recognizes that the COVID-19 pandemic may impact the conduct of clinical trials of medical products, including drugs, devices and biological products.
Challenges may arise, for example, from quarantines, site closures, travel limitations, interruptions to the supply chain for the investigational product, or other considerations if site personnel or trial subjects become infected. These challenges may lead to difficulties in conducting the clinical trials.
The FDA is aware that protocol modifications may be required, and that there may be unavoidable protocol deviations due to COVID-19.