Skip to main content
European Commission logo print header

The GetReal Initiative

Descrizione del progetto

Migliorare la qualità e l’uso delle evidenze reali nello sviluppo e nella regolamentazione farmaceutica

L’Iniziativa in materia di medicinali innovativi (IMI) costituisce il più grande partenariato pubblico-privato al mondo nel settore sanitario, finanziato in egual misura dall’UE e dall’industria farmaceutica. Il progetto GetReal dell’IMI ha analizzato le politiche e le prospettive delle parti interessate sull’utilizzo delle evidenze reali per lo sviluppo precoce dei farmaci e la valutazione dell’efficacia clinica. Il progetto GetReal Initiative, finanziato dall’UE, garantirà che i risultati critici di IMI GetReal siano pienamente sfruttati e sostenibili nel lungo periodo. Riunirà nuovamente i partner di IMI GetReal con l’obiettivo di adottare gli strumenti, le metodologie e le migliori pratiche di quel progetto per migliorare la generazione e l’utilizzo di evidenze reali nello sviluppo e nella regolamentazione farmaceutica.

Obiettivo

The GetReal Initiative brings together partners from the IMI GetReal project to drive the adoption of tools, methodologies and best practices from IMI GetReal and increase the quality of real-world evidence (RWE) generation in medicines development and regulatory/HTA processes across Europe. We will establish, in Work Package (WP) 1, a Think Tank, a number of Task Forces and a RWE Research Community. The Think Tank will consist of international thought leaders and will discuss, assesses and give recommendations on the 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, enagaging with key stakeholder groups to drive policy debate and facilitate the uptake of the outputs of IMI GetReal and the GetReal Initiative. The GetReal Taskforces will drive the focused development of tangible solutions to the key challenges identified in IMI GetReal and the Think Tank. The initial three task forces will be: (i) Pragmatic Trials (design, operational feasibility and analysis/the GetReal PragMagic tool), (ii) network meta-analysis and benefit risk assessment (incl. the GetReal ADDIS tool) and (iii) Statistical Approaches for enriching RCTs with real-world data. The GetReal Research Community will consist of researchers and organisations active in the field of RWE generation, regulators, HTAs, physicians and patients. The Community will review and comment on any GetReal Initiative guidelines, recommendations or white papers ahead of their finalisation, will have access to all the GetReal tools and outputs, receive regular newsletters and receive invitations to attend stakeholder events. The project will also invest in long term sustainability of the GetReal Initiative and the tools on a not-for-profit basis (WP2). The project is supported by professional experienced consortium management (WP3) and an ethics work package (WP4).

Coordinatore

UNIVERSITAIR MEDISCH CENTRUM UTRECHT
Contribution nette de l'UE
€ 525 000,00
Indirizzo
HEIDELBERGLAAN 100
3584 CX Utrecht
Paesi Bassi

Mostra sulla mappa

Regione
West-Nederland Utrecht Utrecht
Tipo di attività
Higher or Secondary Education Establishments
Collegamenti
Costo totale
€ 955 000,00

Partecipanti (16)