Guidance on Multiplicity Analysis in Single-Trial Assessments: A No-Solution Equation

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Authors: Mondher Toumi, Bruno Fallissard, Asma Jouini, Pascal Auquier, Claude Dussart, Laurent Boyer
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Abstract

The European Health Technology Assessment (EU HTA) guidance on Multiplicity of Hypothesis Testing (MHT) [1] resembles an algebra no-solution equation. The hypothetico-deductive method used in inferential statistics, which this guidance references, relies on conclusive reasoning. However, the guidance fails to provide a clear resolution, leaving the matter to individual Member States (MS) despite its critical impact on statistical precision, a key pillar of validity in clinical trials for comparative effectiveness assessments in Joint Clinical Assessments (JCAs).

Fields of Study & Subjects

Statistical Methods in Clinical Trials

Publication details

Journal / source
Journal of Market Access & Health Policy
Volume
14
Issue
3
Pages
46–46
Publication date
4 August 2026
Language
EN