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 (henceforth referred to collectively as assessors) 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.
Member States (MSs) may take the approach of assessing evidence from individual
studies within the framework of the original studies’ statistical analysis plan (SAP)
and/or of assessing a statistical summary (or evidence synthesis) of one or several
studies within the framework of a systematic review. These approaches impact the way
in which different MSs consider specific methodological issues such as multiplicity and
subgroup, sensitivity and post hoc analyses. It is not the intent of this guidance to
endorse a particular approach but to enable MSs to draw their own conclusions at the
national level.
Of note, the analysis and reporting recommendations for assessors are made with the
implicit assumptions that appropriate analyses and information is provided by the health technology developer (HTD). As such, this guidance also has practical implications for the submission dossier which should be taken into account in the preparation of this document…
