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Tuesday, September 26
Tue, Sep 26, 2:45 PM - 4:00 PM
Thurgood Marshall West
Parallel Session: Recent Advancements in Statistical Methods and Tools for Go/No-Go Decision-Making

Statistical Methods for Interpreting Unexpected Results (300564)

*Richard Simon, R Simon Consulting 

Testing a pre-specified null hypothesis for the primary endpoint at the pre-planned final analysis time sometimes does not tell the whole story. Sponsors, FDA reviewers, members of data monitoring committees and FDA advisory committees sometimes must interpret unexpected outcomes of secondary endpoints at unplanned times. I will provide examples of when I have been in this situation and describe the methods I used to arrive at an interpretation.