We are pleased to announce that as of today, 21 October, 2015, the methodological guideline “Endpoints used in Relative Effectiveness Assessment - Safety”, originally published in March 2013 and now adapted within WP7 - Subgroup 3, has entered the public consultation phase.

This consultation will take place between 21 October and 17 November 2015. 

Objective of the methodological guidelines
EUnetHTA´s methodological guidelines are targeted to the needs of health technology assessors in the EUnetHTA member organisations. Their recommendations focus on the methodological challenges encountered while performing relative effectiveness assessments of pharmaceuticals and other health technologies.

Secondary target groups of the guidelines are decision-makers, researchers, industry or other stakeholders as the guidelines inform on what is deemed

  • good quality of study design and conduct,
  • less biased, reliable and applicable evidence,
  • good reporting and synthesis of evidence,
  • and good practice of statistical data analysis in the context of HTA.

The guideline “Endpoints used in Relative Effectiveness Assessment - Safety” has been revised for language changes and supplements necessary to extend the scope of text and recommendations from pharmaceuticals to non-drug interventions with a special focus on medical devices. All changes have been made visible by providing the document in a tracked changes view.

Consultation documents
1. Adapted methodological guideline “Endpoints used for Relative Effectiveness Assessment - Safety”

2. Table of comments Form

How to submit your comments?
Please provide any comments on the adapted methodological guideline using the table of comments form. Please forward the Form by 12:00 noon CET on 17th of November 2015 at the very latest to the Subgroup 3 coordinator joerg.lauterberg@iqwig.de .

The e-mail should contain complete contact data of the sender (name, title, organisation, postal address, telephone number and e-mail address of the sender)

The sender should indicate if he/she submits the comments as an individual or on behalf of an organisation.

If you wish to draw our attention to published literature, please supply the full reference.

The authors are unable to accept:

- Comments received after the consultation deadline
- Comments that are not provided via the table of comments Form
- Confidential information or other material that you would not wish to be made public

What will happen to your comments?

1. All comments will be formally responded to in a combined document, which will be posted on the EUnetHTA website within two months. This document will also contain the names of persons / organisations that properly submitted contributions.

2. No action will be taken upon receipt of late comments.

3. You should receive a response to your email with comments as a confirmation that your comments have been received. If you do not receive this acknowledgement, please contact the coordinator joerg.lauterberg@iqwig.de to ensure your comments have been safely received.

The final version of this methodological guideline will be published on the EUnetHTA website during December 2015.