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

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)