Biostatistics Seminar Series – Yevgen Tymofyeyev, Ph.D.
Yevgen Tymofyeyev, Ph.D.
Scientific Director, Statistical and Decision Sciences, Janssen Research & Development (of Johnson & Johnson)
“Multiple Testing Graphical Approaches for Group Sequential Designs, a Case Study”
Abstract:
As nowadays confirmatory clinical trials become increasingly complex pursuing several goals simultaneously, the graphical testing approach is often used to address testing of multiple hypotheses of interest. This approach for a strong control of the familywise error rate (FWER) has several features that are appealing to clinical teams. For example, it allows for a structured visualized evaluation while developing strategies based on importance of hypotheses and corresponding success likelihoods.
At this presentation we consider recent extensions of the graphical testing procedure to group sequential designs using a case study involving “dual” primary endpoints (pCR and MFS) along with several key secondary endpoints. This constitutes potential multiple paths to establish efficacy based on results at interim and final analyses that needs to be statistically addressed. Furthermore, hypothesis tests might have different numbers of analysis points and different rates of accumulation of statistical information. Study design optimization and practical implementations will be explored.
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Bio3 Seminar Series sponsored by Department of Biostatistics, Bioinformatics & Biomathematics (DBBB)