The Methodological Guidelines for Rapid Relative Effectiveness Assessment of Pharmaceuticals under production by Work Package 5 Joint Action 1 were open for public consultation during the following periods:
29 June – 10 September 2012
- choice of comparator
- composite endpoints
- surrogate endpoints, and
- applicability
3 September – 31 October 2012
- direct and indirect comparisons
- clinical endpoints
- health related quality of life and utility measures
- safety
- internal validity of randomised controlled trials
Objective of the Guidelines
Methodological Guidelines for Rapid Relative Effectiveness Assessment (REA) of Pharmaceuticals are guidelines on methodological challenges that are encountered by health technology assessment (HTA) assessors while performing a rapid relative effectiveness assessment of pharmaceuticals. The primary aim of the guidelines is to help the assessors interpret and process the data that are presented to them as part of a REA.
At the bottom of this page, please find a link to the public consultation document.
Below you will find a list of all 9 guidelines as links to the their designated output pages where you can find each of them:
- Clinical endpoints
- Composite endpoints
- Surrogate endpoints
- Safety
- Health-related quality of life
- Criteria for the choice of the most appropriate comparator(s)
- Direct and indict comparison
- Internal validity
- Applicability of evidence in the context of a relative effectiveness assessment
This document is part of the JA1 Final Technical Report as Deliverable “D3-2 WP5_3b_guidelines_comments and responses public consultation_reduced”.
NOTE: For the full Technical Report, please follow this link.
