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

Abstract Details

Activity Number: 514
Type: Contributed
Date/Time: Wednesday, August 4, 2010 : 10:30 AM to 12:20 PM
Sponsor: Biopharmaceutical Section
Abstract - #307153
Title: Key Considerations for Simulations to Optimize Dose-Finding Trials
Author(s): Natalie Cheung Hall*+
Companies: Eli Lilly and Company
Address: Lilly Corporate Center, Indianapolis, IN, 46285,
Keywords: Optimizing Study Design ; Adaptive Design ; Simulations ; Clinical Trials
Abstract:

In general, trial simulations are increasing becoming a standard approach to optimizing trial design because they can readily account for a complex set of conditions. A key area industry has identified as an opportunity for simulation techniques application is the design of phase 2 trials for dose selection. Adaptive phase 2 dose response designs have been demonstrated to be more efficient than traditional parallel designs in many cases. However, adaptive designs require trial simulations to understand their operating characteristics. In addition, simulations are needed to quantify the benefits of design alternatives in order to select the design that best meets trial objectives. These simulations should incorporate critical performance metrics as well as exploring design variants. I will discuss key considerations for conducting simulations to optimize a phase 2 dose selection design.


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