|
Activity Number:
|
27
|
|
Type:
|
Contributed
|
|
Date/Time:
|
Sunday, August 2, 2009 : 2:00 PM to 3:50 PM
|
|
Sponsor:
|
Biopharmaceutical Section
|
| Abstract - #304287 |
|
Title:
|
Implementation Issues of Randomization Schemes for Adaptive Clinical Trials
|
|
Author(s):
|
Weili He*+ and Frank (Xiaoyin) Fan and Yevgen Tymofyeyev and Olga M. Kuznetsova and Vikas Patel
|
|
Companies:
|
Merck & Co., Inc. and Merck & Co., Inc. and Merck & Co., Inc. and Merck & Co., Inc. and Merck & Co., Inc.
|
|
Address:
|
126 Lincoln Ave., Rahway, NJ, 07065,
|
|
Keywords:
|
Adaptive design ; multistage study design ; response adaptive ; randomization generation ; unblinding
|
|
Abstract:
|
Adaptive design (AD) is defined as a multistage study design that uses accumulating data to decide how to modify aspects of the study without undermining the validity and integrity of the trial (Dragalin 2006). Many sophisticated randomization schemes have arisen from the AD framework (e.g., a response-adaptive randomization). These sophisticated randomization rules pose challenges to companies on the practical aspects of generating AD schedules and randomizing subjects while accommodating the dynamic nature of such randomization. This presentation will summarize various randomization schemes often used in AD trials, discuss the challenges they pose for implementation, and focus on recommendations of the system features that provide implementation efficiency and eliminate the potential for precipitous unblinding of the treatment assignments or the design decisions.
|
