|
Activity Number:
|
399
- Pragmatic Innovations in Clinical Trial Designs: Key to Real Applications
|
|
Type:
|
Invited
|
|
Date/Time:
|
Wednesday, August 10, 2022 : 10:30 AM to 12:20 PM
|
|
Sponsor:
|
ENAR
|
|
Abstract #319257
|
|
|
Title:
|
Application of Group Sequential Methods to 2-in-1 Design
|
|
Author(s):
|
Cong Chen*
|
|
Companies:
|
Merck & Co., Inc.
|
|
Keywords:
|
adaptive design ;
seamless phase 2/3;
oncology
|
|
Abstract:
|
The 2-in-1 adaptive design [Chen et al. 2018] allows seamless expansion of an ongoing Phase 2 trial into a Phase 3 trial to expedite a drug development program. Under a mild assumption that is expected to generally hold in practice, the trial can be tested at the full alpha level with or without expansion. The endpoint used for expansion decision can be the same as or different from the primary endpoints, and there is no restriction on the expansion bar. Due to its flexibility and robustness, it has drawn immediate attention to academic researchers and industry practitioners. The design has been substantially extended in the literature and successfully implemented in multiple trials. Group sequential methods are a cornerstone in trial monitoring. A natural question is whether they can still be applied to the 2-in-1 design. In this talk, we will provide a formal proof to fill the gap. The validity of group sequential methods unlocks the full potential of the 2-in-1 design and paves the way for its wider applications. The techniques used in the proof opens the door for generalized adaptive designs with different endpoints for adaptation decision and hypothesis testing.
|
Authors who are presenting talks have a * after their name.
Back to the full JSM 2022 program
|
