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Methodology Guidelines

The primary objective of EUnetHTA Methdological guidelines is to focus on methdological challenges that are encountered by HTA assessors while performing relative effectiveness assessments of pharmaceuticals or non-pharmaceutical health technologies.

The guidelines represent a consolidated view of non-binding recommendations of EUnetHTA network members and in no case are an official opinion of the participating institutions or individuals.

Guidelines in italics = under revision

Title Version Last Update Link
Process of information retrieval for systematic reviews and health technology assessments on clinical effectiveness 1.2 2017PDF Version
Endpoints used for Relative Effectiveness Assessment: Clinical Endpoints 2.0 2015PDF Version
Endpoints used for Relative Effectiveness Assessment: Composite endpoints 2.0 2015PDF Version
Endpoints used in Relative Effectiveness Assessment: Surrogate Endpoints 2.0 2015PDF Version
Endpoints used in Relative Effectiveness Assessment: Safety 2.0 2015 PDF Version
Endpoints used for Relative Effectiveness Assessment Health: related quality of life and utility measures 2.0 2015PDF Version
Comparators & Comparisons: Criteria for the choice of the most appropriate comparator(s) 2.0 2015PDF Version
Comparators & Comparisons: Direct and indirect comparisons 2.0 2015PDF Version
Levels of Evidence - Applicability of evidence for the context of a relative effectiveness assessment 2.0 2015PDF Version
Internal validity of randomised controlled trials 2.0 2015PDF Version
Internal validity of non-randomised studies (NRS) on interventions 1.0 2015PDF Version
Meta-analysis of diagnostic test accuracy studies 1.0 2014PDF Version
Therapeutic medical devices 1.0 2015PDF Version
Personalised Medicine and Co-Dependent Technologies 0.1 2015PDF Version
Methods for health economic evaluations - A guideline based on current practices in Europe 1.0 2015PDF Version

Guidelines under development

Title Status Planned publication
Critical assessment of clinical evaluations concept 2019
Critical assessment of economic evaluations draft 2018

The production of the EUnetHTA Guidelines has been successfully coordinated by EUnetHTA JA1 WP5 (HAS), EUnetHTA JA2 WP7 SG3 (IQWiG) and EUnetHTA JA3 WP6B (KCE).

If you have suggestions for exisiting guidelines to update or new guidelines to develop, please contact WP6 B coordinator kce_hta@kce.fgov.be

EUnetHTA JA2 Methodology Archive (2012 – 2015)

EUnetHTA JA Methodology Archive (2010 – 2012)