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

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