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Guidance on reporting requirements for multiplicity issues and subgroup, sensitivity and post hoc analyses in joint clinical assessments

This guidance describes how to deal in practice with multiplicity issues and complementary analyses (like specific subgroup analyses, specific post hoc analyses and sensitivity analyses) in joint clinical assessment (JCA) reports. Guidance is provided for assessors, co-assessors and other members of the assessment team on how to report these analyses. Chapter 3 of this guidance contains a list of reporting requirements pertaining to multiple hypothesis testing or complementary analyses which should be included in a JCA.

Read the publication by EC Directorate-General for Health and Food Safety on 13 June 2024.


OpenEdition vous propose de citer ce billet de la manière suivante :
lsgilbert (8 juillet 2024). Guidance on reporting requirements for multiplicity issues and subgroup, sensitivity and post hoc analyses in joint clinical assessments. ELSIBI. Consulté le 18 février 2026 à l’adresse https://doi.org/10.58079/11ymu


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