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. 2024 Nov;50(1):339-340.
doi: 10.1038/s41386-024-01945-9.

Precision functional mapping for target engagement in drug development

Joshua S Siegel  1   2
Affiliations

Precision functional mapping for target engagement in drug development

Joshua S Siegel. Neuropsychopharmacology. 2024 Nov.

Erratum in

No abstract available

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Conflict of interest statement

JSS is co-author of a provisional patent (Patent 020949/US 15060-1787) for the use of precision functional mapping for measuring target engagement by experimental therapeutics. Within the last year, JSS was an employee of Sumitomo Pharma America and received consulting fees from Longitude Capital. These potential conflicts of interest have been reviewed and are managed by Washington University School of Medicine.

Figures

Fig. 1
Fig. 1. Power analysis—conventional drug trial designs and precision imaging drug trials.
We estimate the sample size needed to achieve 90% power to detect a difference between drug and placebo on some brain biomarkers, given the constraints listed and a one-sided significance test. Simply switching from a parallel arm to a cross-over design cuts the sample size needed in ¼. PIDT should cut that number down even further (for reasons outlined above), but additional work is needed to accurately assess the benefit. Random intercept STD (standard deviation) measures the similarity of repeated baseline measures. Random slope STD measures similarity of repeated drug exposure effects.
See this image and copyright information in PMC

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