JSM Preliminary Online Program
This is the preliminary program for the 2009 Joint Statistical Meetings in Washington, DC.

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Activity Number: 50
Type: Invited
Date/Time: Sunday, August 2, 2009 : 4:00 PM to 5:50 PM
Sponsor: Committee on Women in Statistics
Abstract - #303195
Title: Innovations in the Field of Drug Development: From Path Analysis, Benefit-Risk Assessment to Adaptive Trial Design
Author(s): Yili L. Pritchett*+
Companies: Abbott Laboratories
Address: , , 60064,
Keywords: Innovation ; Pharmaceutical statisticians ; path analysis ; Global benefit-risk assessment ; Bayesian adaptive randomization design
Abstract:

New drug development demands tremendous efforts from pharmaceutical statisticians because of the number of clinical trials and the number of analyses involved for any NDA. Finding the most appropriate and efficient statistical methods to support clinical programs and pipeline advancement is challenging and exciting. This talk will share how statisticians can make contributions to drug development through the application of innovative statistical methods. Examples include the application of path analysis to support the development of two distinct indications for a new compound, the creation of global benefit-risk assessment to design a study with head-to-head comparison, and the use of Bayesian adaptive randomization design to enhance the efficiency of early phase clinical trials.


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Revised September, 2008