
Recommendations provided include:
- Modifying study conduct accordingly to ensure safety
- Evaluate alternative methods for trial participants
- Take into account COVID-19 standards in the health care system
- Consider the delay of a trial
- Explore alternative administration possibilities
- Define procedures to prioritize reporting of deviations
- Document all reasons for failure to obtain efficacy endpoints
- Address in the Statistical Analysis Plan (SAP) how protocol deviations related to COVID-19 will be handled