Descripción del proyecto
The aim of ROADMAP is to provide the foundation for a Europe-wide real world evidence (RWE) platform in AD by piloting multi-modal data integration tools and engaging with all key stakeholder groups for consensual definition of patient outcomes, tools and methods that are actionable and relevant. ROADMAP will leverage best practice and exploit synergies with other projects and initiatives at the national and European levels in pursue of scalable and transferable solutions for dataset characterisation, outcome classification, data standards, data sourcing, software application and guidelines on the handling and interpretation of RWE data. In parallel, the project will deepen understanding of the ethical, legal and social implications (ELSI) and health economics (HE) impact of a RWE approach for a meaningful contribution to the Big Data for Better Outcomes programme in IMI2.
The ROADMAP programme will consist of 8 integrated work packages by which the Consortium will work to (1) identify relevant AD outcomes and progression markers; (2) identify and pool AD-related RWE across data sources; (3) develop and validate disease progression models combining diverse datasets and strategies; (4) develop risk/value-based costing and health economics models for HTA/regulators, service providers, industry and carers; (5) establish stakeholder-based guidelines for RWE; (6) develop a communication strategy focussing on the needs of patients and professionals; (7) develop an ELSI framework for the development and application of RWE in AD.
The ROADMAP consortium brings together outstanding expertise, experience and traction in the field, including many of Europe’s top institutions, authorities, companies, experts in AD, biomedical informatics and analysis of epidemiologic and routinely collected health data sources, providing direct connections to key initiatives such as DPUK, EMIF, EPAD and others.