Recording of Virtual Public Meeting Now Available: Mitigating Clinical Study Disruptions During Disasters and Public Health Emergencies (PHEs)

A recording of the virtual public meeting “Mitigating Clinical Study Disruptions During Disasters and Public Health Emergencies (PHEs),” convened by the U.S. Food and Drug Administration (FDA) and Clinical Trials Transformation Initiative (CTTI) held October 18th and 19th, is now available.  

Day 1 of the virtual public meeting opened with welcoming remarks from Janet Woodcock, FDA’s Principal Deputy Commissioner. Following the opening remarks, Jacqueline Corrigan-Curay of the FDA’s Center for Drug Evaluation and Research (CDER) provided an overview of the FDA’s activities and responses to address the COVID-19 public health emergency and clinical trial conduct disruptions. Following the presentations, three panel sessions were held and panelists discussed various topics related to clinical trial disruptions during COVID-19. The first day concluded with closing remarks from CTTI Executive Director Sally Okun.    

Day 2 of the meeting began with opening remarks from Celia Witten of the FDA’s Center for Biologics Evaluation and Research (CBER). Following the opening remarks, panel discussions were held on federal partners’ experience related to trial disruptions and strategies for emergency preparedness in clinical studies. The second and final day of the meeting concluded with closing remarks from M. Khair ElZarrad of the Office of Medical Policy at CDER. 

View the full slide deck to learn more about methods to mitigate clinical study disruptions during disasters and public health emergencies. 

For additional information on the FDA guidance on conduct of clinical trials of medical products during the COVID-19 public health emergency, please see the updated final guidance document. This meeting fulfilled a requirement under section 3605 of the Food and Drug Omnibus Reform Act of 2022 (FDORA).  

Please join us on November 29 and 30, 2023, for another FDORA virtual public workshop on enhancing clinical study diversity. Registration information and a full workshop agenda can be found here.