FDA Introduces Guidance on Conduct of Clinical Trials During the COVID-19 Pandemic

FDA Introduces Guidance on Conduct of Clinical Trials During the COVID-19 Pandemic

The U.S. Food and Drug Administration (FDA) issued guidance for industry, investigators, and institutional review boards conducting clinical trials during the coronavirus (COVID-19) pandemic, the agency recently announced. The agency is exhibiting a pragmatic sense of urgency, sharing with those conducting clinical trials the federal authority’s understanding of the extreme conditions now faced by the nation. The FDA seeks to keep clinical research going and is offering a level of flexibility to work with sponsors to manage how clinical trials may be impacted by changing conditions on the ground.

Challenges Associated with this Pandemic

The agency recognizes that the COVID-19 pandemic may impact the conduct of clinical trials of medical products, such as drugs, devices, and biological products. They indicate that considerable challenges could manifest—for example, involving quarantines, site closures, travel limitations, interruptions to the supply chain for the investigational product, or other material factors if investigator site personnel become infected with SARS-CoV-2.

The Implications of the Challenges?

Sponsors and sites may face increasing difficulty in conduc...

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