JSM Preliminary Online Program
This is the preliminary program for the 2006 Joint Statistical Meetings in Seattle, Washington.

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Activity Number: 296
Type: Luncheons
Date/Time: Tuesday, August 8, 2006 : 12:30 PM to 1:50 PM
Sponsor: Biopharmaceutical Section
Abstract - #305494
Title: Decision Rules Based on Multiple Endpoints in Clinical Trials
Author(s): Alex Dmitrienko*+
Companies: Eli Lilly and Company
Address: 10913 W. 144th Street, Overland Park, KS, 66221,
Keywords: multiple endpoints ; clinical trials ; multiplicity
Abstract:

This luncheon will focus on issues arising in clinical trials with multiple endpoints. We will begin with a general discussion of the role of multiple endpoints in early (proof-of-concept) and registration trials, relevant regulatory considerations, and popular testing strategies---including the reverse multiplicity problem (all endpoints must be significant to achieve a positive outcome). The discussion also will touch upon statistical issues, such as the control of the false-positive rate, analysis of multiple endpoints (overall effect versus analysis of the individual variables), and interpretation of secondary findings and their use in product labels (gatekeeping strategies). Examples from a real trial will be used throughout the discussion to illustrate the approaches being discussed.

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Revised April, 2006