Cytel's Response: FDA Guidance On Conduct Of Clinical Trials During The COVID-19 Pandemic

The FDA recently issued a guidance on how the COVID-19 Pandemic may affect the conduct of clinical trials. following are some key messages from the guidance along with some interpretations and recommendations on topics including

• Completing Data Collection
• Handling Missing Information
• Protocol Modifications for Efficacy Assessments
• Amendments to Data Management and Statistical Analysis Plan