Note: This news item was updated March 31, 2020, to note the new appendix FDA has added to the guidance.
FDA has released the guidance document FDA Guidance on Conduct of Clinical Trials of Medical Products during the COVID-19 Pandemic. This guidance for industry, investigators, and IRBs seeks “support continuity and response efforts” to the pandemic and is being implemented immediately.
For ongoing trials, “ensuring safety of trial participants is paramount.” FDA recommends that sponsors assess each situation and modify study activities as appropriate to minimize the potential impact on participant safety. These changes will vary depending on the protocol and local situation. Sponsors and investigators should be sure to document any such contingency measures and the rationale for implementing the changes.
FDA encourages sponsors and investigators to engage proactively with the study’s IRB of record when developing contingency plans. Any study changes made in response to the current pandemic should be reported to the IRB according to standard reporting requirements.
When necessary to eliminate apparent immediate hazards to participants, researchers may implement changes prior to IRB review and approval of the research changes—however, those changes must still be reported promptly to the IRB.
FDA amended this guidance on March 27, 2020, to include the appendix “Questions And Answers” to address questions FDA has received regarding clinical trial conduct during the COVID-19 pandemic.
Advarra has policies and processes in place to keep IRB, IBC, and all other operations functioning as normal during this public health emergency. For more information, review the article Impact on COVID-19 Outbreak on Ongoing Research and Protocols Under Advarra IRB Review.