JSM 2004 - Toronto

Abstract #301717

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Activity Number: 120
Type: Contributed
Date/Time: Monday, August 9, 2004 : 10:30 AM to 12:20 PM
Sponsor: Section on Statistical Education
Abstract - #301717
Title: A Course in Randomization, Clinical Study Designs, Allocation Schedules, and Interactive Voice Response Systems for Clinical Research Personnel
Author(s): Gregory T. Golm*+ and Thomas Bradstreet and Laura A. Coffey
Companies: Merck & Co., Inc. and Merck & Co., Inc. and Merck & Co., Inc.
Address: 785 Jolly Rd., Blue Bell, PA, 19422,
Keywords: allocation schedule ; statistical education ; Interactive Voice Response System
Abstract:

In most clinical trials, randomized treatment assignment is one of the most important features that enable valid statistical inference. Randomization schedules (allocation schedules for patients and component schedules for Interactive Voice Response Systems) provide the blueprints for carrying out the randomization scheme according to the study design and thus form a nexus between statistical theory and clinical practice. Designing and executing a randomization schedule involves people across a wide variety of job roles, many of whom are not formally trained in all aspects of the randomization process. We have developed a highly interactive course for clinical research personnel that explains both the theory behind the randomization schedule and the practical aspects of its implementation. The course includes group workshops based on a wide variety of real clinical trial examples.


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Revised March 2004