Challenges in Histological Endpoints for <scp>MASH</scp> Therapies: An Exercise in Statistical Modelling
Imprecise histologic scoring disproportionately impacts the 'superior' arm as the error is proportional to the true response rate. This dilution of effect size should be considered when weighing the clinical benefit and the overall risk-benefit profile in the review of NASH studies. This argues for the adoption of non-invasive biomarkers rather than histologic endpoints.
Authors
- Leigh MacConell
- Adrian M. Di Bisceglie (ORCID: https://orcid.org/0000-0002-6075-9305)
- A. Sender Liberman (ORCID: https://orcid.org/0000-0002-4494-4834)
- Д. А. Шапиро (ORCID: https://orcid.org/0000-0003-1116-7298)
- Amrik Shah
Institutions
- Fate Therapeutics (United States) (US)
- Saint Louis University (US)
Publication Details
- Journal
- Alimentary Pharmacology & Therapeutics
- Published
- 2025-02-13
- DOI
- https://doi.org/10.1111/apt.70023
- Citations
- 2
- Primary Topic
- Liver Disease Diagnosis and Treatment
- Type
- article
- Field-Weighted Citation Impact
- 2.71