Covid Guidance on Clinical Trials Revised

FDA has added content to a question-and-answer appendix in its guidance titled Conduct of Clinical Trials of Medical Products During Covid-19 Public Health Emergency. The updated document’s added question pertains to considerations for disposing unused investigational drug products when a study participant cannot return it to the study site. It addresses considerations for using alternative procedures for the disposition of the investigational product provided that such procedures do not expose humans to risks from the drug.

FDA issued the guidance because it recognizes the potential challenges in conducting clinical trials may arise from isolation practices, site closures, travel limitations, interruptions to the supply chain for the investigational product, or other considerations if site personnel or clinical trial participants contract Covid-19. “FDA is aware that protocol modifications may be required, and that there may be unavoidable protocol deviations due to Covid-19,” the document says.