The Main Working Groups
Work package 1: Advocacy, community building and implementation of tools.
Community building is an integral part of the adoption strategy, therefore, WP1 will build on the unique collaboration framework created in the original IMI GetReal project to provide the infrastructure (the GetReal Community) through which the GetReal Initiative will collaborate with other major initiatives, organisations, key stakeholders, thought leaders and scientists working in the field of RWE generation and analysis, in addition to regulators, key healthcare decision makers, physicians and patients. The collaboration will be utilised to disseminate solutions which encompass the tools created in IMI GetReal to tackle major obstacles facing the use of RWE in effectiveness research and in healthcare decision making. WP1 will compose of three main groups:
The GetReal Think Tank will consist of senior leaders from the GetReal Initiative members and nominated international thought leaders in the generation and use of RWE. This group will discuss, assesses and give recommendations on the prioritisation of opportunities and barriers to the generation, use and acceptability of RWE. They will act as ambassadors for the use of RWE during the project and beyond, engaging with key stakeholder groups to drive policy debates and facilitate the uptake of the outputs of the original GetReal project and the GetReal Task Forces into daily practice.
The Task Forces are initiated to drive the focused development of tangible solutions to the key challenges identified in IMI GetReal and the Think Tank. Two Task Forces have been identified based on the key deliverables and RWE Policy Recommendations previously developed by the original IMI GetReal project with the aim of refining and facilitating the uptake of the tools by key stakeholder groups:
- Task Force A: GetReal Pragmatic Trial Task Force
- Task Force B: Network meta-analysis including randomised and non-randomised studies and benefit-risk assessment
Furthermore, additional Task Forces may be added in alignment with the GetReal Policy Recommendations and in response to evolving policy topics.
Researchers and organisations active in the field of RWE generation, regulators, HTAs, physicians and patients will have the opportunity to register to be a member of the GetReal Research Community. More information on this community will follow later on in the project.
Work package 2: Long term sustainability of the GetReal Initiative on a not-for-profit basis.
The goal of WP2 is to ensure the continuity of the GetReal Research Community, GetReal Think Tank/Task Forces and GetReal tools/key outputs beyond the period of the IMI2 funding, through the development of a broadly supported business plan, governance structure and the creation of a small self-sustaining unit, run on a not-for-profit basis.
Work package 3: Project management and communication.
WP3 will address the overall project management to ensure progress of the project towards its planned objectives and is responsible for communication activities of the project.
Work package 4: Ethics.
The goal of WP4 is to deal with all the relevant ethical issues in order to comply with the ethics standards of H2020 and to establish a sustainable governance for the data infrastructure during the project and beyond.