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Multiplicity Issues in Confirmatory Clinical Trials

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Outline

This free online conference focuses on recent advances in the area of multiple comparisons, including methods for "multidimensional" multiplicity problems known as gatekeeping procedures. Gatekeeping procedures have been widely used in clinical trials with multiple objectives due to the fact that they control the overall Type I error rate and enable trial sponsors to enrich product labels by including information on relevant secondary objectives. The individual presentations provide information on the development of gatekeeping procedures in confirmatory clinical trials with examples from real clinical trials and discuss regulatory considerations.

Presentations

Analysis of Clinical Trials with Multiple Objectives by Alex Dmitrienko (Eli Lilly and Company).

Hommel-based Gatekeeping Multiple Comparison Procedure by Jane Xu (Sunovion).

Truncated Holm Tests: Power Implications on Strong Control of the Type I Error Rate by Christopher Holland (Macrogenics).

Registration

To register for this free online conference, visit SPRMM web page.