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Activity Number: 577
Type: Invited
Date/Time: Wednesday, August 12, 2015 : 2:00 PM to 3:50 PM
Sponsor: ENAR
Abstract #314369
Title: On Clinical Trials with a High Placebo Response Rate
Author(s): George Y.H. Chi* and Yihan Li and Yanning Liu and David Lewin and Pilar Lim
Companies: Janssen R&D and AbbVie and Janssen R&D and Janssen R&D and Janssen R&D
Keywords: Adjusted treatment effect ; Combination test ; Consistency test ; Doubly randomized delayed start design ; Joint test ; Sequential parallel design with re-randomization

The basic reason for the failure of many standard randomized parallel placebo-controlled clinical trials with high placebo response rate is that the observed relative treatment difference only provides an estimate of the apparent treatment effect since the true treatment effect has been diminished by the presence of a substantial proportion of placebo responders in the population. Analogous to an active control trial, the true treatment effect cannot be measured by the relative treatment difference. An appropriate assessment of the true treatment effect is critical for making a risk/benefit analysis and dosage recommendation. The primary purpose of this paper is to propose a method for adjusting the apparent treatment effect to account for the high placebo response rate within the framework of a doubly randomized delayed start design.

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

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