JSM 2014 Home
Online Program Home
My Program

Abstract Details

Activity Number: 488
Type: Topic Contributed
Date/Time: Wednesday, August 6, 2014 : 10:30 AM to 12:20 PM
Sponsor: Biometrics Section
Abstract #311039 View Presentation
Title: Challenges Posed by Treatment Switches in the Assessment of Safety of Hiv Drugs
Author(s): Susan Gruber*+ and Mark J. van der Laan
Companies: Harvard School of Public Health and University of California, Berkeley
Keywords: treatment switch ; safety analysis ; causal inference
Abstract:

In order to assess the effect of anti-retroviral drugs on safety outcomes we analyzed data from multi-arm RCTs that were designed with efficacy in mind. Subjects switched from their baseline treatment assignment for a variety of reasons, including an increase in viral load, a decrease in CD4 count, occurrence of an adverse event, and difficulty of compliance. Some of these decisions are unrelated to the safety outcomes of interest, which allows us to view a subset of switching events as uninformative right censoring. For the remaining reasons, switching is informative. If the decision to switch is nearly deterministic, there may be insufficient support in the data to answer some causal questions of interest, and causal questions may have to be re-formulated. Different approaches for analyzing the data rely on different sets of identifiability assumptions, whose plausibility depends on the particular dataset under consideration. In this talk we characterize the challenges, and present advantages and limitations of different analytical approaches that can exploit longitudinal patient-level data to address complications introduced by treatment switching decisions.


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

Back to the full JSM 2014 program




2014 JSM Online Program Home

For information, contact jsm@amstat.org or phone (888) 231-3473.

If you have questions about the Professional Development program, please 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.

ASA Meetings Department  •  732 North Washington Street, Alexandria, VA 22314  •  (703) 684-1221  •  meetings@amstat.org
Copyright © American Statistical Association.