WP7 Subgroup 2 is pleased to announce the publication of its final deliverable – the Core protocol Pilot for Additional Evidence Generation (AEG).
This pilot consists of two parts:
– Defining core elements of a study protocol for AEG and developing the template of a Core protocol for AEG (section 1)
– Testing the developed template, and WP7 SG2 methodological documents, on an example technology, in this case Renal denervation (section 2).
The template of a Core protocol for AEG (section 1) is directed to both HTA agencies\national bodies and to study sponsors. HTA agencies can use it as a basis to set up requirements for a common study or multiple coordinated AEG requests. For sponsors it can serve as guidance when drafting their study protocols for AEG.
The Core protocol for AEG on renal denervation (section 2) contains advice on evidence gaps and all specified core elements that are necessary to produce the needed additional evidence. The information is presented in the form of a study protocol, but which contains only “core elements”. In order to be implemented and further used, the Core protocol has to be completed with further information (“additional elements”), and adapted to specific national requirements, if needed.
The output of this pilot is the core protocol itself, not the conduct of a study (study funding or implementation are not within scope of this exercise).
Any questions to the pilot and comments can be directed to Irena Guzina, HAS, at email@example.com