Online Program

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All Times EDT

Thursday, September 24
Thu, Sep 24, 1:30 PM - 2:45 PM
TBD
Global Impact of COVID-19 on the Design and Analysis of Clinical Trials and the Path Forward

Statistical Issues and Recommendations for Clinical Trials Conducted During the COVID-19 Pandemic COVID-19 Pandemic (302307)

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*Dan Meyer, Pfizer 

The COVID-19 pandemic has had and continues to have major impacts on planned and ongoing clinical trials. Its effects on trial data create multiple potential statistical issues. The scale of impact is unprecedented, but when viewed individually, many of the issues are well defined and feasible to address. Several strategies and recommendations are put forward to assess and address issues related to estimands, missing data, validity and modifications of statistical analysis methods, need for additional analyses, ability to meet objectives and overall trial interpretability. These recommendations represent the contributions of statisticians from 15 major pharmaceutical companies.