JSM 2015 Preliminary Program

Online Program Home
My Program

Abstract Details

Activity Number: 657
Type: Contributed
Date/Time: Thursday, August 13, 2015 : 8:30 AM to 10:20 AM
Sponsor: Biopharmaceutical Section
Abstract #315865 View Presentation
Title: Exchangeability and Nonexchangeability in Subgroup Analysis
Author(s): Margaret Gamalo-Siebers* and Ram Tiwari
Companies: FDA/CDER and FDA/CDER/OT/OB
Keywords: Subgroup ; Bayes ; Dirichlet
Abstract:

Traditionally, clinical trials have primarily been concerned with comparing treatments on an entire population to provide the most reliable data about the effects of treatments. But due to the need to streamline drug development, in areas of high unmet medical need, subgroup analysis has started to play a different role. For example, the FDA released a draft Guidance on antibacterial therapies for unmet medical need and notes the possibility to use innovative design strategies including Bayesian modeling approaches for assessing subgroup-specific treatment effects in trials involving multi-site infections instead of starting with multiple clinical trials in different sites. Given this paradigm, I will talk about accounting for exchangeability and/or non-exchangeability in subgroup analysis. I will also explore models for estimating effects at each of these subgroups using varying assumptions of exchangeability and/or non-exchangeability and evaluate bias in the estimates.


Authors who are presenting talks have a * after their name.

Back to the full JSM 2015 program





For program information, contact the JSM Registration Department or phone (888) 231-3473.

For Professional Development information, contact the Education Department.

The views expressed here are those of the individual authors and not necessarily those of the JSM sponsors, their officers, or their staff.

2015 JSM Online Program Home