COVID-19 Pandemic: Response To Regulatory Guidance

A number of non-COVID related trials are facing disruptions due to the coronavirus pandemic. Cancelled patient visits, new comorbidities, and more resource constraints have resulted in missing data, questions about recalibrated SAPs, and concerns about maintaining statistical power. Cytel co-hosted a panel with Simon Day (Former Manager of the Statistics Unit, MHRA) and Greg Campbell (Former FDA Biostatistics Director), to talk through some of these challenges.