Multiplicity Issues in Confirmatory Clinical Trials

Instant Conference

This Instant Conference is available free of charge to all members of the Instant Training Program.

Half-day conference

Total duration: 1 hours 34 minutes.

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Outline

The 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

Speaker: Alex Dmitrienko (Mediana Inc). Duration: 37 minutes.

Hommel-based Gatekeeping Multiple Comparison Procedure

Speaker: Jane Xu (Sunovion). Duration: 26 minutes.

Truncated Holm Tests: Power Implications on Strong Control of the Type I Error Rate

Speaker: Christopher Holland (Macrogenics). Duration: 31 minutes.

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