1. 1
Real world Outcomes across the AD spectrum for better care:
Multi-modal data Access Platform
The Innovative Medicines Initiative (IMI) is a joint undertaking between the European Union and the
pharmaceutical industryassociation EFPIA. ROADMAP is a private-public partnership (PPP) formed under
the IMI umbrella to develop efficient uses of real world evidence (RWE) for the benefit of Alzheimer’s
Disease (AD) patients and their caregivers.
Expertise and Technology:
ROADMAPbringstogethermanyof Europe’stop academicinstitutionsandexpertsindementia todelivera
series of data integration methods and tools across diverse data types and across healthcare systems, to
optimise the use of RWE (clinical practice data) in AD; many of these experts have worked on other PPPs
and bring that experience to the project
Co-ownership:
ROADMAP will transparently address the interests of healthcare providers, industry, regulators, payers,
patients and governments leading to shared best practice and potentially greater efficiency and
responsiveness to important healthcare questions in AD.
Expected Key Deliverables:
 Define a minimum set of measureable real‐world patient outcomes.
 DeveloprecommendationsonRWEappropriate AD‐related cognitive, functional, and behavioural
endpoints.
 Identify data sources and outline a data integration strategy for RWE outcomes.
 Develop new methods for collecting RWE data to improve health care value for AD.
 Provide recommendations for disease progression and health economic modelling.
 Under the leadership of UK NICE and the Dutch Regulator (MEB), deliver guiding principles and
recommendations from HTA groups/payers/regulators for the development and incorporation of
RWE into clinical and market access development plans for AD.
Expected Impact and timelines:
ROADMAPaims to provide the foundation for a much needed Europe-wide integrated data environment
and framework for RWE across the spectrum of disease
Phase 1 of this project will run over 2 years from November 2016 - December 2018. Key findings from
Phase 1 of ROADMAP will likely determine a further three year Phase 2 project for the prospective
collection of key clinical and health economic outcomes in AD.
Reference: IMI-2 ROADS at http://www.imi.europa.eu/content/stage-1-17