|
Activity Number:
|
481
|
|
Type:
|
Roundtables
|
|
Date/Time:
|
Wednesday, August 5, 2009 : 12:30 PM to 1:50 PM
|
|
Sponsor:
|
Biopharmaceutical Section
|
| Abstract - #304142 |
|
Title:
|
Adaptive Clinical Trials: Interim Data Analysis Challenges
|
|
Author(s):
|
Darcy Hille*+ and Paulette Ceesay
|
|
Companies:
|
Merck & Co., Inc. and Merck & Co., Inc.
|
|
Address:
|
UG1C-46, North Wales, PA, 19454,
|
|
Keywords:
|
adaptive clinical trial ; interim analysis ; clinical trial efficiency
|
|
Abstract:
|
An adaptive clinical trial design is defined as a multistage study design that uses accumulating data to decide on how to modify aspects of the study without undermining the validity and integrity of the trial. Various innovative statistical methodologies may be employed to analyze interim data for adaptive designs in order to improve efficiency and cost effectiveness. However, challenges such as slow enrollment and missing data issues may undermine the goal of the adaptive design. We plan to lead a discussion of the various challenges that pose a threat to achieving the goals of the interim analyses.
|
