Statistical Guidance For COVID-19 Impacted Trials

By Heather Kopetskie, Director of Biostatistics

Clinical trials conducted during the COVID-19 pandemic have been impacted by public health measures to control the virus. Impacts may include delayed protocol start, trial participants not able to visit clinical sites for assessments, interruptions in supply chain, and entire site closures, to name a few. In June, the FDA released a guidance on  Statistical Considerations for Clinical Trials During the COVID-19 Public Health Emergency. Below is a brief summary of the FDA guidance and some examples of activities Rho has undertaken to maintain trial integrity and patient safety in ongoing and upcoming clinical trials.