This is the program for the 2010 Joint Statistical Meetings in Vancouver, British Columbia.

Abstract Details

Activity Number: 501
Type: Topic Contributed
Date/Time: Wednesday, August 4, 2010 : 10:30 AM to 12:20 PM
Sponsor: Biopharmaceutical Section
Abstract - #307085
Title: Control Group Bias in RCTs: Methodologic Issues with Application to Atypical Antipsychotic Trials in Schizophrenia
Author(s): Robert Makuch*+ and Ralitza Gueorguieva and Scott Woods and Scott Woods
Companies: Yale University and Yale University and Yale University and Yale University
Address: LEPH 203, New Haven, CT, 06520,
Keywords: active control ; randomized control trial ; schizophrenia studies ; random effects analysis
Abstract:

There are suggestions that use of concurrent placebo control groups in schizophrenia RCTs could be minimized/eliminated by making comparisons instead to an external placebo (ie, the external historical control assumption). This strategy makes use of a constancy assumption, that the new compound performs similarly in an RCT involving only an active control as it would have if a concurrent placebo control were included. In this presentation, we present a method to examine this less well-known assumption. Using a random-effects analysis, we show that in atypical antipsychotic medicine trials the extent of improvement was roughly twice as large in active control trials than seen in placebo control studies that used the same drugs and dosages. Because control group bias seems present in schizophrenia RCTs, caution is needed when using active control studies that have no concurrent placebo.


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