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The COVID-19 pandemic has impacted clinical development and ongoing clinical trials. Public health measures to control the virus may have adversely affected the ability to collect data, for example, if trial participants were not able to visit clinical sites for endpoint assessments.
FDA has issued a guidance on “Statistical Considerations for Clinical Trials During the COVID-19 Public Health Emergency.” This presentation will focus on statistical considerations for proposed changes to trial conduct that may impact the analysis and interpretation of the primary or key secondary endpoints. This session will discuss FDA’s final guidance on the topic and address areas such as trial integrity, missing data, and modifications to study endpoints.