The U.S. Food and Drug Administration (FDA) issued a guidance for industry, investigators and institutional review boards conducting clinical trials during the coronavirus (COVID-19) pandemic.
The guidance is designed to advise researchers conducting clinical trials for drugs, devices and biologic products about how to address challenges that may occur as a result of the COVID-19 pandemic.
In the guidance, the FDA says it outlines considerations to assist sponsors in assuring the safety of trial participants, maintaining compliance with good clinical practice and minimizing risks to trial integrity. Some of the recommendations include evaluating alternative methods for assessments, such as phone contacts or virtual visits, and offering additional safety monitoring for those trial participants who may no longer have access to investigational product or the investigational site.
Some of the challenges sponsors of clinical trials may have to overcome include quarantines, site closures, travel limitations or interruptions to the supply chain for the investigational product. It’s also possible that site personnel or trial subjects become infected with SARS-CoV-2, the virus that causes COVID-19, the FDA said in a statement.
