JA-WP5 EUnetHTA Joint Action (2010-12)
2013 - PDF

This guideline provides a set of recommendations and aspects to be considered for the assessment and interpretation of results of composite endpoints while performing relative effectiveness assessment of pharmaceuticals.

A composite endpoint (CE) consists of two or more single events combined in one outcome that should represent an overall clinically relevant and valid measure of clinical benefit due to treatment. It is possible to combine binary or time-to-event endpoints. Either the occurrence of any event from a given set of events is of interest, or the time to the occurrence of the first event. Composite endpoints usually refer to combined morbidity and mortality endpoints; it may also be a combination of objective (e.g. laboratory measurements) and subjective outcomes (e.g. pain); in this case, clinical relevance of overall results can be more difficult to interpret.

Please find the guideline on composite endpoints at the bottom of this page

Full list of guidelines

This document is part of the JA1 Final Technical Report as Deliverable "D3-2WP5_3a2_Composite endpoints"
NOTE: For the full Technical Report, please follow this link