The FDA acknowledged that protocol modifications or deviations may be required for clinical trials during the COVID-19 pandemic.
The FDA today issued a guidance on clinical trials during the novel coronavirus (COVID-19) pandemic for industry, investigators and institutional review boards (IRBs).1 The guidance emphasizes patient safety, compliance with good clinical practice, and maintaining the integrity of clinical trials.1,2
In a statement, the FDA said that potential challenges caused by this pandemic may affect clinical trials for medical products, including drugs, devices, and biological products. Some possible challenges include quarantines of patients or site personnel, site closures, travel limitations, and interruptions to the supply chain for the investigational product.1
“With this guidance issued today, the FDA is helping industry and investigators navigate the COVID-19 pandemic, and help assess how to move forward with critical clinical trials,” said Anand Shah, MD, FDA deputy commissioner for Medical and Scientific Affairs, in a prepared statement.1
The FDA acknowledged that protocol modifications or deviations may be required for clinical trials during the COVID-19 pandemic, and outlined considerations in the guidance for sponsors. Considerations recommended by the FDA include, among others, sponsors evaluating alternative methods for assessments, such as contacting patients by phone or virtual visits, and offering additional safety monitoring for those trial participants who may not have access to the investigational product or the trial site.1,2
The FDA also recommends, among other things, consultation with appropriate review divisions regarding protocol modifications in the collection of efficacy endpoints. Protocol changes leading to the amendment of data management or statistical analysis plans should be made under consultation with review divisions. 2
Those sponsors, clinical investigators, and IRBs without existing contingency measures should consider implementing these measures.2