Report Now Available: Mitigating Clinical Study Disruptions During Disasters and Public Health Emergencies

The report on the two-day virtual public meeting, “Mitigating Clinical Study Disruptions During Disasters and Public Health Emergencies (PHEs),” convened by the U.S. Food and Drug Administration (FDA) in collaboration with the Clinical Trials Transformation Initiative (CTTI), is now available. 

The meeting, which was held on October 18 and 19, 2023 with 720 global attendees, discussed recommendations provided by the FDA during the COVID-19 public health emergency to mitigate disruption of clinical studies, including recommendations detailed in the guidance entitled “Conduct of Clinical Trials of Medical Products During the COVID-19 Public Health Emergency, Guidance for Industry, Investigators, and Institutional Review Boards.” The meeting also featured speakers and panelists from across the clinical trials enterprise, including representatives from Medtronic, the National Cancer Institute (NCI), the National Institutes of Health (NIH), Roche, and many more, who shared the experiences, best practices, and strategies they used to effectively navigate disruptions to clinical studies during the COVID-19 public health emergency.  

The meeting fulfilled a requirement under section 3605 of the Food and Drug Omnibus Reform Act of 2022 (FDORA). For more information about this meeting, visit CTTI’s website to view the resources including the final report, the presentation slides and the recording of the meeting.