Project Objectives
Define and catalogue scales and consensus-based methodologies for identifying AD outcomes from routinely collected data (Work Package 2 Outcome Definition)
Identify and pool AD-related RWE data and establish solution options for how to combine different RWE sources with RCT data supporting pharmacoeconomic evaluation (Work Package 3 Identification, mapping and integration of RWE)
Develop and validate a core disease progression model combining diverse datasets to facilitate analysis of disease trajectories and effect of interventions on disease trajectories (Work Package 4 Disease Modelling and Simulation)
Develop a proof of concept AD cost-effectiveness and budget impact model for HTA agencies, regulators, service providers, industry, payers and carers (Work Package 5 Health Economics)
Develop guiding principles and recommendations from HTA/payers/regulators for the development and incorporation of RWE into clinical and market access development plans for AD (Work Package 6 Regulatory and HTA Engagement)
Develop and implement a communication strategy focusing on the needs of patients and professionals (Work Package 7 Communication and Patient/ Healthcare Provider Engagement)
Develop an ELSI framework with extensive patient involvement for the development and application of RWE in AD (Work Package 8 Ethical, Legal and Social Implications (ELSI))
Develop a full plan for phase 2 of the ROADMAP initiative that addresses identified gaps and pitfalls, and exploits promising solutions to their full potential for development of a European RWE platform in AD (Work Package 1 Project Management and Coordination)