This is the program for the 2010 Joint Statistical Meetings in Vancouver, British Columbia.
Abstract Details
Activity Number:
|
256
|
Type:
|
Contributed
|
Date/Time:
|
Monday, August 2, 2010 : 2:00 PM to 3:50 PM
|
Sponsor:
|
Biopharmaceutical Section
|
Abstract - #308661 |
Title:
|
A Simulation Study to Evaluate Dose-Response in Dose-Titration Clinical Trials: A Dynamic Linear Mixed Effect (DLME) Modeling Approach
|
Author(s):
|
Xu Steven Xu*+ and Min Yuan and Julia Wang and Partha Nandy
|
Companies:
|
Johnson & Johnson and Fudan University, China and Johnson & Johnson and Johnson & Johnson
|
Address:
|
920 Route 202, Raritan, NJ, 08869,
|
Keywords:
|
dose response ;
titration design ;
feedback ;
simulation ;
dynamic model ;
selection bias
|
Abstract:
|
Assessing dose response from dose-titration clinical trials is often problematic due to the selection bias caused by the feedback from the response process to the dosing process. We investigate the performance of a DLME in identifying dose response from titration studies using simulations. The simulations demonstrate that DLME estimator is unbiased (< 0.5%). A nominal 95% confidence interval for the dose-response based on the DLME estimator covered the true value in ~85% of the simulations, showing that the asymptotic confidence interval has reasonable coverage. Compared to the situation, where dose titration is randomly assigned and not related to the response (no feedback), the efficiency of the DLME estimator only reduced by 12% when the feedback is present. In conclusion, DLME models may provide a modeling option in identifying dose response relationship in dose-titration designs.
|
The address information is for the authors that have a + after their name.
Authors who are presenting talks have a * after their name.
Back to the full JSM 2010 program
|
2010 JSM Online Program Home
For information, contact jsm@amstat.org or phone (888) 231-3473.
If you have questions about the Continuing Education program, please contact the Education Department.