The FDA has issued the guidance document, Conduct of Clinical Trials of Medical Products During COVID-19 Public Health Emergency, because the agency recognizes that the public health emergency caused by COVID-19 has impacted the conduct of clinical trials of medical products, including drugs, devices, and biologics. These challenges may arise from isolation practices, site closures, travel limitations, interruptions to the supply chain, or other concerns if site personnel or trial participants contract COVID-19.
The FDA has updated this guidance document with a new question and answer regarding considerations for disposing unused investigational drug product when a trial participant is unable to return to the study site. Considerations are addressed for using alternative methods for the disposition of the product provided that such procedures do not expose humans to risks from the drug.
COVID-19’s impact on trial studies will vary, causing protocol modifications that may be required as well as protocol deviations. The FDA’s guidance also outlines general considerations in order to assist sponsors in assuring the safety of trial participants as well as maintaining compliance with good clinical practice and minimizing risk to trial integrity.
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