This is the program for the 2010 Joint Statistical Meetings in Vancouver, British Columbia.

Abstract Details

Activity Number: 645
Type: Invited
Date/Time: Thursday, August 5, 2010 : 10:30 AM to 12:20 PM
Sponsor: Biopharmaceutical Section
Abstract - #306322
Title: Variations of and Types of Statistical Control for Multiplicity in Clinical Trials: The Academic Perspective
Author(s): Joseph Massaro*+ and Ralph B. D'Agostino, Sr.+
Companies: Boston University and Boston University
Address: 801 Massachusetts Ave, Boston, MA, 02118, USA Mathematics and Statistics Department, Boston , MA, 02215,
Keywords: multiplicity ; multiple outcomes ; multiple testing ; alpha control ; statistical control ; clinical trial

Dealing with multiplicity and maintaining statistical control remains a major area of concern in randomized clinical trials. The Food and Drug Administration (FDA) is in the process of publishing a guidance document. In the present talk we consider the many issues (e.g., primary outcome, co-primary outcomes, composite outcomes, subgroup analysis, interaction analyses and missing data issue). In each case we state the issue, why statistical control is essential, various approaches to achieve control and recommendations for dealing appropriately with the problem. Our objective is to focus on the issues as seen from the academics involved in the clinical trial and to anticipate how the new FDA guideline document may consider the issue.

We also believe that the issues of multiplicity will relate to other major concerns in clinical trials and will discuss the unity of these issues.

The address information is for the authors that have a + after their name.
Authors who are presenting talks have a * after their name.

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