|
Activity Number:
|
323
- Adaptive Enrichment Designs in Clinical Trials
|
|
Type:
|
Topic Contributed
|
|
Date/Time:
|
Tuesday, August 9, 2022 : 2:00 PM to 3:50 PM
|
|
Sponsor:
|
Biopharmaceutical Section
|
|
Abstract #322459
|
|
|
Title:
|
Adaptive Designs with Modified Testing Hierarchy at the Interim
|
|
Author(s):
|
George Kordzakhia* and Cassie Dong and Eiji Ishida
|
|
Companies:
|
Astra Zeneca and Takeda and Sunovion
|
|
Keywords:
|
gatekeeping procedures;
interim analysis;
multiple comparions;
adaptive design
|
|
Abstract:
|
This presentation considers a general framework for defining mixture-based gatekeeping procedures in clinical trials with multiple hierarchies at the interim and final analyses. The framework supports serial logical restrictions for the null hypotheses. If interim analysis results are not successful, final analysis can utilize an alternative hierarchy / set of logical relationships. Example(s) will be provided to illustrate how this approach can be applied to a common class of multiplicity problems.
|
Authors who are presenting talks have a * after their name.
