The development of the methodological guidance in the areas where such guidance is missing was included already in the work plan of the EUnetHTA JA (2010-2012). Contribution to developing and testing a methodological basis for European cooperation on HTA including guidelines for distinct methodological issues was one of the objectives of the EUnetHTA JA2 (2012-2015). Specifically in EUnetHTA JA2 (2012-2015), the scope of work on producing methodological guidelines focused on development of “methodological guidelines on pertinent issues of assessment (e.g. for devices) or update existing guidelines according to needs and resources”.
EUnetHTA JA2 (2012 - 2015)
a) Updated EUnetHTA JA (2010 - 2012) Methodological Guidelines for rapid relative effectiveness assessment (REA)
The EUnetHTA JA2 Work Package 7 member organisations reviewed the contents of the EUnetHTA JA (2010-2012) methodological guidelines on REA of pharmaceuticals (see below). They decided to extend the scope of the text and recommendations from pharmaceuticals only to the assessment of all health technologies. Content and recommendations remained unchanged.
1. Endpoints used for Relative Effectiveness Assessment Clinical Endpoints_Amended JA1 Guideline_Final Nov 2015
2. Endpoints used for Relative Effectiveness Assessment Composite endpoints Amended JA1 Guideline Final Nov 2015
3. Endpoints used in Relative Effectiveness Assessment Surrogate Endpoints Amended JA1 Guideline Final Nov 2015
4. Endpoints used in Relative Effectiveness Assessment Safety Amended JA1 Guideline Final Nov 2015
5. Endpoints used for Relative Effectiveness Assessment Health related quality of life and utility measures Amended JA1 Guideline Final Nov 2015
6. Comparators & Comparisons Criteria for the choice of the most appropriate comparator(s) Amended JA1 Guideline Final Nov 2015
7. Comparators & Comparisons Direct and indirect comparisons Amended JA1 Guideline Final Nov 2015
8. Internal validity of randomised controlled trials
9. Levels of Evidence - Applicability of evidence for the context of a relative effectiveness assessment Amended JA1 Guideline Final Nov 2015
b) Newly developed Methodological Guidelines
10. Meta-analysis of diagnostic test accuracy studies
11. Methods for health economic evaluations - A guideline based on current practices in Europe
12. Internal validity of non-randomised studies (NRS) on interventions
13. Process of information retrieval for systematic reviews and health technology assessments on clinical effectiveness
14. Therapeutic medical devices
c) Reflection Paper on Personalised Medicine and Co-Dependent Technologies
The draft reflection paper was delivered to the European Commission among the outputs of the EUnetHTA JA2 WP7 by the end of EUnetHTA JA2 (March 2016). The draft paper was put to undergo further public consultation with an intent to continue the work on the subject in EUnetHTA.
EUnetHTA JA (2010 - 2012)
Methodological guidelines for rapid relative effectiveness assessment (REA) of Pharmaceuticals
1. Clinical endpoints
2. Composite endpoints
3. Surrogate endpoints
5. Health-related quality of life
6. Criteria for the choice of the most appropriate comparator(s)
7. Direct and indirect comparison
8. Internal validity
9. Applicability of evidence in the context of a relative effectiveness assessment
Please note that the updated versions of these Guidelines can be found under JA2 Guidelines above on this page.