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Activity Number:
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263
- Addressing a Validity Crisis in Biobehavioral Research: Novel Approaches to Machine Learning and Clinical Data Analysis
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Type:
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Invited
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Date/Time:
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Wednesday, August 11, 2021 : 1:30 PM to 3:20 PM
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Sponsor:
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Mental Health Statistics Section
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Abstract #316666
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Title:
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Real Effect vs. Apparent Effect: Placebo Response in Neuropharmacology Trials
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Author(s):
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Pilar Lim*
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Companies:
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Janssen Research & Development, LLC
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Keywords:
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placebo response;
neuropharmacology clinical trials
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Abstract:
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High placebo response rates have been a major source of difficulty in many neuropharmacology clinical trials and their effects have been difficult to overcome in developing new compounds. This presentation will present a focused discussion on the difference between the real treatment effect and the apparent treatment effect in trials involving a patient population with a high placebo response rate. The essential issues will be discussed, including how to define the estimand or the effect of treatment in such trials. Designs that adjust for placebo response have been proposed in the literature. However, existing approaches appear to have ignored the issue of properly specifying the estimand and testing the appropriate hypothesis. This presentation will attempt to provide clarity around the issues and encourage continued research in this important area.
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Authors who are presenting talks have a * after their name.
