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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

TitleVersionLast UpdateLink
Process of information retrieval for systematic reviews and health technology assessments on clinical effectiveness2.02019PDF Version
Endpoints used for Relative Effectiveness Assessment: Clinical Endpoints2.02015PDF Version
Endpoints used for Relative Effectiveness Assessment: Composite endpoints2.02015PDF Version
Endpoints used in Relative Effectiveness Assessment: Surrogate Endpoints2.02015PDF Version
Endpoints used in Relative Effectiveness Assessment: Safety2.02015 PDF Version
Endpoints used for Relative Effectiveness Assessment Health: related quality of life and utility measures2.02015PDF Version
Comparators & Comparisons: Criteria for the choice of the most appropriate comparator(s)2.02015PDF Version
Comparators & Comparisons: Direct and indirect comparisons2.02015PDF Version
Levels of Evidence - Applicability of evidence for the context of a relative effectiveness assessment2.02015PDF Version
Internal validity of randomised controlled trials2.02015PDF Version
Internal validity of non-randomised studies (NRS) on interventions1.02015PDF Version
Meta-analysis of diagnostic test accuracy studies1.02014PDF Version
Therapeutic medical devices1.02015PDF Version
Personalised Medicine and Co-Dependent Technologies0.12015PDF Version
Methods for health economic evaluations - A guideline based on current practices in Europe1.02015PDF Version
Practical considerations when critically assessing economic evaluations. Guidance document1.02020PDF Version

Guidelines under development

Title Status Planned publication
Critical assessment of clinical evaluationsConcept2020

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 wish to provide feedback on an existing EUnetHTA Methodological Guideline, please make use of the  below template:


PLEG guidance

The following documentation has been produced during JA1 and JA2, as outputs of EUnetHTA JA1 and JA2 WP7, under the coordination of HAS.

Position Paper on research recommendations for AEG

Position Paper on study design for AEG

Core Protocol Pilot for AEG

Selection Prioritisation Criteria for AEG