WP7 Subgroup 2 is pleased to announce the public consultation on the Core protocol Pilot for Additional Evidence Generation (AEG).
This consultation will take place between July 23rd and August 23rd 2015.
Objectives of the pilot
The objective of the Core protocol Pilot for AEG is to:
- Agree on core (key) elements of a protocol for AEG and develop a core protocol template that could be used for studies in different countries;
- Test the developed template and two WP7 SG2 methodological papers, on an example technology in need of AEG identified in an HTA report: Renal denervation systems for treatment-resistant hypertension.
This exercise should assess the feasibility of coordinating an AEG request in Europe – defining a common question and a common core protocol to respond. The final objective is to overcome the hurdle of having multiple uncoordinated study requests, and propose a core study protocol that will allow, when needed, the collection of consistent and poolable data.
The output of the pilot is the core protocol itself, not the conduct of a study (study funding or implementation are not within scope of this exercise).
Consultation documents
- Draft “Core protocol Pilot for Additional Evidence Generation
- Table of comments Form.
How to submit your comments?
Please provide your comments on the draft by using the table of comments form, and forward it by August 23rd 2015 to WP7 SG2 coordinator i.guzina@has-sante.fr
The sender should indicate if he/she submits the comments as an individual or on behalf of an organization.
If you wish to draw our attention to published literature, please supply the full reference.
The authors are unable to accept:
- Comments that are not in English
- 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?
- All comments will be formally responded to in a combined document, which will be posted on the EUnetHTA website once the Pilot is finalized. This document will also contain the names of persons/organizations that properly submitted contributions
- No action will be taken upon receipt of late comments.
- You should receive an acknowledgement of receipt of your email with comments. If you do not receive this acknowledgement, please contact the coordinator i.guzina@has-sante.fr to ensure your comments have been safely received.
The final version of the pilot will be published on the EUnetHTA website in September 2015.
eunethta_core_protocol_pilot_for_aeg
table_of_comments_core_protocol_pilot_for_aeg
