This is the program for the 2010 Joint Statistical Meetings in Vancouver, British Columbia.
Abstract Details
Activity Number:
|
552
|
Type:
|
Invited
|
Date/Time:
|
Wednesday, August 4, 2010 : 2:00 PM to 3:50 PM
|
Sponsor:
|
Section on Bayesian Statistical Science
|
Abstract - #306128 |
Title:
|
Combining Information Across Studies for Clinical Trials: What We Have Learned at FDA's Center for Devices and Radiological Health
|
Author(s):
|
Laura Thompson*+
|
Companies:
|
FDA/CDRH
|
Address:
|
10903 New Hampshire Ave, Silver Spring, MD, 20993,
|
Keywords:
|
hierarchical model ;
fda ;
medical devices ;
prior studies ;
Bayesian
|
Abstract:
|
I will discuss the Center's experience reviewing applications that propose to combine results across prior and current studies via a Bayesian hierarchical model. Some considerations that CDRH uses in the evaluation of whether a hierarchical model is appropriate include the assessment of exchangeability, calculation of the prior probability of the study claim, sensitivity of hyperparameters of the random effects distribution, and the decision on whether to borrow among treatment differences or among treatment means. I will also discuss model checking and sensitivity analysis. I will focus on both parametric and nonparametric distributions, and indicate where a nonparametric approach is appropriate. I will briefly discuss other examples where hierarchical models can and have been used in medical device studies, such as for multiple comparisons, diagnostic assessment, and meta-analysis.
|
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.