The U.S. Food and Drug Administration (FDA) updated their “Guidance on Conduct of Clinical Trials of Medical Products During COVID-19 Public Health Emergency,” offering sponsors (industry, academic, gov, non-profit) recommendations for existing activities as well as forthcoming clinical trials. The U.S. regulatory agency is working to help sponsors and sites deal with the significant impediments introduced with the onset of the COVID-19 pandemic. All FDA guidance documents must be understood for what they are—recommendations. They are not legally enforceable responsibilities.
These changes are relevant for those interested—or with a professional duty—to understand how the FDA is thinking about the impact of quarantines, site closures, travel limitations and other interruptions to the supply chain for the investigational product or for that matter other considerations involving the infection of site personnel or of study participants. How can sponsors adjust the trial to deal with these issues?
Flexibility for Protocol Changes
The FDA “recognizes that protocol modifications may be required, and that there may be unavoidable protocol deviations due to COVID-19illness and/pr COVID-19 public health control measures.” The level and extent that sponsor and sites must consider health control measures for specific clinical trials actually depends on the specific disease under study, the nature of the trial (its design, etc.) and the geographic location (rural vs. urban, etc.).
FDA Recommendations based on Trial Status
The FDA breaks down or segments its advice based on the status of a clinical trial. For example, those studies that were in existence before the onset of the pandemic (e.g. ongoing trials) versus those clinical trials that are just starting (e.g. policies and procedures are actually not yet in place).
Call to Action: Follow the link for the finalized guidance.