JSM 2011 Online Program

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Abstract Details

Activity Number: 111
Type: Topic Contributed
Date/Time: Monday, August 1, 2011 : 8:30 AM to 10:20 AM
Sponsor: Section for Statistical Programmers and Analysts
Abstract - #302942
Title: The Future of Statistical Analyst's Work in the Pharmaceutical Industry: Trial Simulation
Author(s): Natalie Cheung Hall*+
Companies: Eli Lilly and Company
Address: 11797 Ledgestone Cir, Fishers, IN, 46037,
Keywords: Trial Simulations ; Clinical Trial Design ; Statistical Programming
Abstract:

In the pharmaceutical industry, the search for more efficient and safer trial designs requires increased use of trial simulations. These simulations allow project teams to vary components of a study in order to identify the benefits and risks of each scenario and arrive at the optimal trial design. However, the output from these simulations, whether performed through software or custom code, are voluminous and lack interpretability in their raw form. This talk will illustrate the statistical analyst's challenge of evaluating the data quickly and thoroughly, and communicating the operating characteristics of each trial scenario to the project team in order to make an informed decision about the study design. A number of key tools (e.g., simulation software, trial simulation plan template) that aid in this process will also be discussed.


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