On March 18, 2020, the U.S. Food and Drug Administration (FDA) issued a guidance for industry, investigators, and institutional review boards conducting clinical trials during the COVID-19 coronavirus pandemic in recognition that it may affect the conduct of clinical trials of medical products, including drugs, devices, and biologic products.
Quarantines, site closures, travel limitations, interruptions to the supply chain for the investigational product, or other considerations if site personnel or trial subjects develop COVID-19 may lead to difficulties in conducting the clinical trials. FDA is aware that protocol modifications or deviations may be required or unavoidable because of COVID-19. Although COVID-19’s impact on trials will vary depending on many factors, including the nature of disease under study, the trial design, and regions in which the study is being conducted, the guideline outlines considerations to assist sponsors in ensuring the safety of trial participants, maintaining compliance with good clinical practice and minimizing risks to trial integrity.
Considerations recommended include sponsors evaluating alternative methods for assessments, such as phone contacts or virtual visits, and offering additional safety monitoring for clinical trial participants who may no longer have access to the investigational product or site.
“With this guidance, FDA is helping industry and investigators navigate the COVID-19 pandemic and help assess how to move forward with critical clinical trials,” Anand Shah, MD, FDA deputy commissioner for medical and scientific affairs, said. “The FDA released the guidance to emphasize that at all times, patients’ safety should continue to be at the forefront of considerations. We want to support the continuance of these clinical trials in compliance with good clinical practice and minimizing risks to trial integrity, while also safeguarding the health and well-being of study participants.”