|
Activity Number:
|
34
|
|
Type:
|
Contributed
|
|
Date/Time:
|
Sunday, August 3, 2008 : 2:00 PM to 3:50 PM
|
|
Sponsor:
|
Biopharmaceutical Section
|
| Abstract - #300858 |
|
Title:
|
Optimization of Design Features in Clinical Trials with a Sensitive Subgroup
|
|
Author(s):
|
Yan D. Zhao*+ and Alex Dmitrienko and Roy Tamura
|
|
Companies:
|
Eli Lilly and Company and Eli Lilly and Company and Eli Lilly and Company
|
|
Address:
|
Lilly Corporate Center, Indianapolis, IN, 46285,
|
|
Keywords:
|
Clinical trial design ; sensitive subgroup ; optimal design ; type I error control ; power ; simulation
|
|
Abstract:
|
This talk introduces a method for optimizing the design of clinical trials with a sensitive subgroup of patients (i.e., a subgroup that is more likely to benefit from the treatment than the overall population). Given a sensitive subgroup (defined by a classifier [e.g., a clinical marker or pharmacogenomic marker]), the study's outcome is declared positive if the treatment effect is established in the overall population or the subgroup. The proposed method aims at achieving an optimal balance between the power of the overall and subgroup tests under restrictions that reflect the trial's objective. The restrictions include control of the overall Type I error rate and requirement to show that the overall treatment effect, if it is demonstrated, is not limited only to the sensitive subgroup. Operating characteristics of the proposed design are assessed via a simulation study.
|
