Statistical Challenges in Preserving Integrity of Ongoing Clinical Trials During the COVID-19 Pandemic

Challenges, potential solutions for maintaining scientific accuracy and regulatory compliance.

The COVID-19 pandemic is an unparalleled global event that has caught all sectors of business off-guard. The pharmaceutical industry is a patient-centric one and is being impacted in ways not seen before. The implications of this situation are far-reaching and wide.

This whitepaper will discuss:

• Challenges posed to clinical trials
• Modifying the sample size
• Estimands and missing data
• Improving data quality through Centralized Statistical Monitoring
• Solutions to maintaining scientific accuracy and regulatory compliance
• The need for flexibility, without affecting patients’ safety and study validity