Design of Clinical Trials in new onset type 1 diabetes: Regulatory considerations for drug development

On June 15-16, C-Path organised a workshop about Design of Clinical Trials in New-Onset Type 1 Diabetes: Regulatory Considerations for Drug Development. Together with the U.S. Food and Drug Administration (FDA), European Medicines Agency (EMA), and in collaboration with Benaroya Research Institute, INNODIA and JDRF, this 2-day public workshop focused on the implementation of endpoints and outcome measures for clinical trials in new onset type 1 diabetes (T1D). More than 300 researchers, pharmaceutical representatives, academia members, investigators, T1D patients and regulatory experts from throughout the United States and Europe gathered virtually to hear 15 presentations about T1D research and medical product development. Kyle J. Rose - INNODIA PAC member - stressed the importance of patient involvement.