EUnetHTA-EMA f-t-f meeting summary 20131210, Cologne Germany
Please find below the summary of the EUnetHTA / EMA face-to-face meeting, 10 December 2013, Cologne, Germany EMA-EUnetHTA meeting_Cologne December 2013_meeting summary_FINAL.pdf
WP5 JA1 Pilot Pazopanib Report+Appendix
The final version of the WP5 JA1 pilot assessment using the draft model for Rapid Relative Effectiveness Assessment of Pharmaceuticals and guidelines. The joint assessment involved the participation of 22 HTA organisations as authors on different domains or as reviewers. Find the full list on page 16 in side the report. The final version of the WP5 […]
Responses to Public consultation of the draft Project Plan on Endobarrier
The draft Project Plan on “Duodenal-jejunal bypass sleeve (Endobarrier®) for the treatment of obesity” was open to public consultation between 21 March and 4 April 2013. This document presents the comments through the public consultation. The aim of the Project Plan is to provide an overview on the planned processes, the scope, the scientific methods […]
Public consultation of the Methodological Guidelines for Rapid Relative Effectiveness Assessment of Pharmaceuticals
This document presents the public consultation of WP5 Joint Action Methodological Guidelines for Rapid Relative Effectiveness Assessment of Pharmaceuticals. 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 […]
Methodological guideline for REA of pharmaceuticals: Composite endpoints
This guideline provides a set of recommendations for the selection and assessment of clinical endpoints when completing a Relative Effectiveness Assessment (REA) 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. […]
Methodological guideline for REA of pharmaceuticals: Internal validity
This guideline focuses on the assessment of the risk of bias of randomized controlled trials (RCTs), the most relevant trials for relative effectiveness assessment (REA) of pharmaceuticals. The quality assessment of non-randomized and diagnostic accuracy studies will be elaborated in separate guidelines. Likewise, a separate guideline deals with the problem of assessing applicability. Internal validity describes […]
Methodological guideline for REA of pharmaceuticals: Applicability of evidence in the context of a REA
This guideline provides a set of recommendations and aspects to be considered for the assessment of applicability in the context of a relative effectiveness assessment. Applicability, also known as external validity/ generalisability/ or transposability, is the extent to which the effects observed in clinical studies are likely to reflect the expected results when a specific […]
List of comments for the WP5 JA1 Pilot Pazopanib Report
The list of comments for the WP5 JA1 Pilot Pazopanib Report. The list provides the contact information of all the organisations that properly submitted their contributions. The list of comments for the WP5 JA1 Pilot Pazopanib Report. The list provides the contact information of all the organisations that properly submitted their contributions. This document is […]
List of commentators for the WP5 JA1 Pilot Pazopanib Report
The list with commentators provides the contact information of all the organisations that properly submitted contributions. The list with commentators provides the contact information of all the organisations that properly submitted contributions. List of commentators for the WP5 JA1 Pilot Pazopanib Report
JA1 Technical Report – WP1: Appendix 2
This document is Appendix 2 for WP1 under the JA1 Final Technical Report: “EUnetHTA Plenary Assembly meeting summary, May 24-25, 2012, Lisbon, Portugal” Please note that within this appendix, you will find references to its own set of 5 annexes. These are all included in the document attached below. NOTE: For the full Technical Report, […]
