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One of the most important reasons for failure of placebo-controlled randomized controlled clinical trials (RCTs) is the lack of appropriate methodologies for detecting treatment effect (TE = difference between placebo and active treatment response) in presence of excessively low/high levels of placebo response. Although, the higher the level of placebo response in a trial, the lower the apparent detectable TE. TE is usually estimated in a conventional analysis of a RCT as an 'apparent' TE value conditional to the level of placebo response in that RCT. A model-informed methodology is proposed to establish a relationship between level of placebo response and TE. This relationship is used to estimate the 'typical' TE associated with a 'typical' level of placebo response irrespectively of the level of placebo response observed. The approach can be valuable for providing a reliable estimate of TE, for conducting risk/benefit analysis and for determining dosage recommendations. This article is protected by copyright. All rights reserved.
This article was published in the following journal.
Name: Clinical pharmacology and therapeutics
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