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