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Activity Number: 51
Type: Topic Contributed
Date/Time: Sunday, August 6, 2006 : 4:00 PM to 5:50 PM
Sponsor: Section on Statistical Computing
Abstract - #306718
Title: Use of Open-Source Software by an Academic Center in a Regulatory Environment
Author(s): Thomas D. Cook*+
Companies: University of Wisconsin-Madison
Address: 209 WARF, Madison, WI, 53726,
Keywords: open source software ; clinical trials ; interim analysis
Abstract:

The Statistical Data Analysis Center (SDAC) in the Department of Biostatistics and Medical Informatics at the University of Wisconsin-Madison serves as the independent analysis center supporting data and safety monitoring boards for industry-sponsored, multicenter, randomized clinical trials. Interim analyses conducted at SDAC are subject to scrutiny by various scientific, regulatory, and ethics groups within the United States and internationally. In this environment, the conduct of interim analyses requires a balance between timeliness, completeness, and accuracy. To optimally satisfy these competing goals, SDAC uses a hybrid of propriety and open-source software, using each for the applications in which it is best suited. We will describe the system currently in place at SDAC and the advantages and disadvantages of various software tools.

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Revised April, 2006