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Name ROADMAP
Long Name Real world outcomes across the AD spectrum for better care: multi-modal data access platform
Description Real world outcomes across the AD spectrum for better care: multi-modal data access platform. Alzheimer’s disease is on the rise in our ageing population, and new, effective treatments are urgently needed. Currently, the safety and benefits to patients of potential treatments are assessed in strictly-controlled clinical trials. However, clinical trials do not provide information on the health benefits for patients in their daily lives in the ‘real world’. The ROADMAP project aims to deliver a series of methods and tools that will allow the scalable, transferable integration of data on patient outcomes in the real world. The tools will be developed and tested through pilot projects and will lay the foundations for a Europe-wide platform on real world evidence in Alzheimer’s disease. The project will also deliver tools for patient engagement and address the ethical, legal and social implications of adopting a real world evidence approach to Alzheimer’s disease. The project is part of IMI’s Big Data for Better Outcomes programme, which aims to facilitate the use of diverse data sources to deliver results that reflect health outcomes of treatments that are meaningful for patients, clinicians, regulators, researchers, healthcare decision-makers, and others.
Objectives 1. Define and catalogue scales and consensus-based methodologies for identifying AD outcomes from routinely collected data. 2. Identify and pool AD-related RWE data and establish solution options for how to combine different RWE sources with RCT data supporting pharmacoeconomic evaluation. 3. Develop and validate a core disease progression model combining diverse datasets to facilitate analysis of disease trajectories and effect of interventions on disease trajectories. 4. Develop a proof of concept AD cost-effectiveness and budget impact model for HTA agencies, regulators, service providers, industry, payers and carers. 5. 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. 6. Develop and implement a communication strategy focusing on the needs of patients and professionals. 7. Develop an ELSI framework with extensive patient involvement for the development and application of RWE in AD. 8. 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.
Website https://roadmap-alzheimer.org/
Start date 01-11-2016
End date 31-10-2018
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Name Projects Type of institution Country  
Synapse Research Management Partners SL EPAD AMYPAD NEURONET EMIF ROADMAP SME Spain
University Of Edinburgh EPAD AMYPAD EQIPD ROADMAP Academia United Kingdom
Janssen Pharmaceutica NV EPAD ADAPTED AMYPAD IMPRiND EQIPD NEURONET EMIF IM2PACT PHAGO PRISM RADAR-CNS RADAR-AD ROADMAP IDEA-FAST Pharma-Cog EPND EFPIA Belgium
National Institute For Health And Care Excellence NEURONET ROADMAP HTA body/Regulatory agency United Kingdom
Alzheimer Europe EPAD AMYPAD MOPEAD AETIONOMY EMIF RADAR-AD ROADMAP NEURONET Pharma-Cog EPND Patient/carers organisation Luxembourg
Eli Lilly And Company Ltd EPAD IMPRiND MOPEAD PHAGO PRISM RADAR-AD ROADMAP NEURONET IDEA-FAST Pharma-Cog EFPIA United Kingdom
F. Hoffmann-La Roche AG EPAD EQIPD EMIF PHAGO PRISM ROADMAP NEURONET IDEA-FAST Pharma-Cog EPND EFPIA Switzerland
Ac Immune SA EPAD ROADMAP EPND EFPIA Switzerland
Biogen Idec Limited EPAD RADAR-CNS ROADMAP ADAPTED IDEA-FAST EFPIA United Kingdom
H. Lundbeck As EPAD IMPRiND IM2PACT PD-MitoQUANT PHAGO RADAR-CNS ROADMAP Pharma-Cog EFPIA Denmark
Novartis Pharma AG EPAD IMPRiND EQIPD AETIONOMY IM2PACT PRISM RADAR-AD ROADMAP Mobilise-D Pharma-Cog EPND EFPIA Switzerland
University Of Oxford EPAD IMPRiND IM2PACT RADAR-AD ROADMAP EMIF EPND Academia United Kingdom
Academisch Ziekenhuis Leiden PRISM IM2PACT ROADMAP IDEA-FAST PRISM2 Academia Netherlands
Erasmus Universitair Medisch Centrum Rotterdam PRISM ADAPTED AETIONOMY EMIF ROADMAP EPAD IDEA-FAST Academia Netherlands
Rijksuniversiteit Groningen PRISM EQIPD ROADMAP PRISM2 Academia Netherlands
Aarhus Universitet IMPRiND IM2PACT ROADMAP EMIF Academia Denmark
IXICO Technologies LTD AMYPAD ROADMAP EPAD SME United Kingdom
GE healthcare Ltd AMYPAD ROADMAP EFPIA United Kingdom
Kobenhavns Universitet IM2PACT ROADMAP EMIF Academia Denmark
Goeteborgs Universitet PHAGO ROADMAP EMIF EPND Academia Sweden
Agentschap College Ter Beoordeling Van Geneesmiddelen RADAR-AD ROADMAP EPND Academia Netherlands
Chu Hopitaux De Bordeaux ROADMAP Academia France
Fundacio Institut Universitari Per a La Recerca A L'Atencio Primaria De Salut Jordi Gol i Gurina ROADMAP EMIF Academia Spain
London School Of Economics And Political Science ROADMAP Academia United Kingdom
Universiteit Maastricht ROADMAP EMIF EPND Academia Netherlands
Takeda Pharmaceuticals International AG EPND EPAD PRISM RADAR-AD ROADMAP IDEA-FAST Mobilise-D NEURONET EFPIA Switzerland
WP number Description Project  
WP1 Project Management and Coordination ROADMAP
WP2 Outcome Definition ROADMAP
WP3 Identification, mapping and integration of RWE ROADMAP
WP4 Disease Modelling and Simulation ROADMAP
WP5 Health Economics ROADMAP
WP6 Regulatory and HTA Engagement ROADMAP
WP7 Communication and Patient/Healthcare Provider Engagement ROADMAP
WP8 Ethical, Legal and Social Implications (ELSI) ROADMAP
Deliverable number Title Project Submission date Link Keywords  
D3.5 Guidelines for use of smart devices as a measure of RWE ROADMAP 28-09-2018 https://roadmap-alzheimer.org/wp-content/uploads/2018/11/ROADMAP_Deliverable-Report-3.5-final.pdf
D2.1 First list of priority Real World Evidence relevant outcomes for AD ROADMAP 15-03-2017 http://roadmap-alzheimer.org/wp-content/uploads/2017/04/116020_ROADMAP_D2.1_First-list-of-priority-RWE-outcomes-for-AD.pdf
D7.1 Project website ROADMAP 13-04-2017 http://roadmap-alzheimer.org/wp-content/uploads/2017/04/116020_ROADMAP_D7.1_Project-website.pdf
D7.3 Inital set of communication tools ROADMAP 24-04-2017 http://roadmap-alzheimer.org/wp-content/uploads/2017/04/116020_ROADMAP_D7.3_Initial-set-of-communication-tools_v1.3.pdf
D4.1 Catalogue of RWE relevant AD models and simplistic disease stage framework ROADMAP 28-04-2017 https://roadmap-alzheimer.org/wp-content/uploads/2018/09/116020_ROADMAP_D4.1_Catalogue-of-RWE-relevant-AD-models-and-simplistic-disease-stage-framework.pdf
D3.1 Initial Overview of potential data sources with RWE data in Europe ROADMAP 15-05-2017 http://roadmap-alzheimer.org/wp-content/uploads/2017/05/116020_ROADMAP_D3.1_Overview-of-potential-data-sources.pdf
D8.1 Review of ELSI issues in RWE approach ROADMAP 23-06-2017 https://roadmap-alzheimer.org/wp-content/uploads/2018/08/116020_ROADMAP_D8.1_Review-of-ELSI-issues-in-RWE-approach.pdf
D7.4 Interim Report on dissemination activities and communication strategy update ROADMAP 08-11-2017 http://roadmap-alzheimer.org/wp-content/uploads/2017/11/116020_ROADMAP_D7.4-Interim-Report-on-dissemination-activities-and-communication-strategy-update-V1.4.pdf
D2.3.1 Stakeholder generated lists of priority real world evidence relevant outcomes for Alzheimer’s disease ROADMAP 14-12-2017 https://roadmap-alzheimer.org/wp-content/uploads/2018/01/116020_ROADMAP_D2.3.1_Stakeholder-lists-of-priority-outcomes-for-AD_interim_v3.pdf
D2.2.1 Report of systematic review of published and unpublished data identifying important and relevant outcomes in AD and criteria for disease progression ROADMAP 19-12-2017 https://roadmap-alzheimer.org/wp-content/uploads/2018/01/116020_ROADMAP_D2.2.1_SLR-on-relevant-outcomes-in-AD_interim.pdf
D3.2 First report on proof of concept technical solutions for RWE data harmonisation and integration ROADMAP 25-01-2018 https://roadmap-alzheimer.org/wp-content/uploads/2018/02/116020_ROADMAP_D3.2_First-report-on-PoC-technical-solutions_v4.pdf
D2.2 Report of systematic review of published and unpublished data identifying important and relevant outcomes in AD and criteria for disease progression ROADMAP 09-03-2018 https://roadmap-alzheimer.org/wp-content/uploads/2018/03/116020_ROADMAP_D2.2_SLR_Final.pdf
D8.3 Brief on findings of ELSI focus groups for a RWE approach to AD ROADMAP 11-05-2018 https://roadmap-alzheimer.org/wp-content/uploads/2018/11/ROADMAP_D8.3_ELSI_Focus_Groups_v4.0.pdf
D4.5 Report on results from ‘hypothesis-free’ disease trajectory analyses ROADMAP 31-05-2018 https://roadmap-alzheimer.org/wp-content/uploads/2018/05/ROADMAP_D4.5_V3.0.pdf
D2.3 & D2.4 COMBINED REPORT Stakeholder generated lists of priority RWE relevant outcomes and D2.4 Disease progression and outcomes classification matrix ROADMAP 29-06-2018 https://roadmap-alzheimer.org/wp-content/uploads/2018/07/ROADMAP_D2.3D2.4.pdf
D4.3 Selection of appropriate disease models for validation ROADMAP 14-09-2018 https://roadmap-alzheimer.org/wp-content/uploads/2018/11/ROADMAP_Deliverable-4.3_final.pdf
D3.4 Final report on proof of concept technical solutions for RWE data harmonisation and integration ROADMAP 05-10-2018 https://roadmap-alzheimer.org/wp-content/uploads/2018/10/D3.4_Final-report-on-PoC-technical-solutions_v5.0.pdf
D3.3 Update of potential data sources with RWE data in Europe ROADMAP 15-10-2018 https://roadmap-alzheimer.org/wp-content/uploads/2018/10/D3.3-Update-of-potential-data-sources-with-RWE-data-in-Europe.pdf
D7.5 Final report on dissemination activities (including impact measures) and project tools developed ROADMAP 17-10-2018 https://roadmap-alzheimer.org/wp-content/uploads/2018/10/116020_ROADMAP_D7.5-Final-report-on-dissemination-activities-including-impact-measures-and-project-tools-developed-_v1.3.pdf
D3.6 Guidelines for combining RCT, cohort, and EHR‚Äêbased data for RWE in AD ROADMAP 23-10-2018 https://roadmap-alzheimer.org/wp-content/uploads/2018/10/116020_ROADMAPD3.6-Guidelines-for-combining-RCT-cohort-and-EHR%E2%80%90based-data-for-RWE-in-AD.pdf
D2.5 Summary of gaps between data requirements and currently available data ROADMAP 25-10-2018 https://roadmap-alzheimer.org/wp-content/uploads/2018/10/D2.5-Summary-of-gaps-between-data-requirements-and-currently-available-data.pdf
D6.3 Guiding principles and recommendations for the development and incorporation of RWE into clinical and market access development plans for AD ROADMAP 04-12-2018 https://roadmap-alzheimer.org/wp-content/uploads/2018/12/D6.3-Guiding-principles-and-recommendations-for-the-incorporation-of-RWE.pdf
D4.6 Report on results from analysis of pharmacological interventions ROADMAP 18-12-2018 https://roadmap-alzheimer.org/wp-content/uploads/2018/12/D4.6_Report-on-results-from-analysis-of-pharmacological-interventions_v4.0.pdf
D4.4 Results from pilot model validation exercises ROADMAP 18-02-2018 https://roadmap-alzheimer.org/wp-content/uploads/2018/12/ROADMAP_D4.4_v1.3.pdf
D5.3 Mapping algorithms from real world outcomes to preference based measures: QoL-AD to EQ-5D ROADMAP 17-12-2018 https://ec.europa.eu/research/participants/documents/downloadPublic?documentIds=080166e5c017bde3&appId=PPGMS Mapping algorithm , Cross-walking, Health related quality of life, Preference based measures, Dementia
D6.1 Interim report on the EXAG activities and outputs ROADMAP 04-01-2018 https://ec.europa.eu/research/participants/documents/downloadPublic?documentIds=080166e5b9254ee8&appId=PPGMS
D8.4 Landscaping paper on ethics of outcome prioritisation in AD treatment ROADMAP 13-09-2018 https://ec.europa.eu/research/participants/documents/downloadPublic?documentIds=080166e5bd9a9c65&appId=PPGMS
D8.5 Final report on requirements for ELSI framework for a RWE approach in AD ROADMAP 05-11-2018 https://ec.europa.eu/research/participants/documents/downloadPublic?documentIds=080166e5bef32830&appId=PPGMS
D5.4 Economic evaluation of new technologies for use in Alzheimer’s disease: a model specification guide ROADMAP 08-11-2017 https://ec.europa.eu/research/participants/documents/downloadPublic?documentIds=080166e5c0531b0a&appId=PPGMS
D4.7 Recommendations for the development/interpretation of RWE AD models ROADMAP 24-01-2019 https://ec.europa.eu/research/participants/documents/downloadPublic?documentIds=080166e5c0caf2a2&appId=PPGMS
Title First author last name Year Project Link Keywords  
Challenges for Optimizing Real-World Evidence in Alzheimer’s Disease: The ROADMAP Project Gallacher 2019 ROADMAP https://doi.org/10.3233/JAD-180370 Editorial, Alzheimer’s disease, data sharing, data systems, health policy, patient outcome assessment, real-world clinical trials, systems integration
What outcomes are important to patients with Mild Cognitive Impairment or Alzheimer’s disease, their caregivers and healthcare professionals? A systematic review Tochel 2019 ROADMAP https://doi.org/10.1016/j.dadm.2018.12.003 Systematic review, Alzheimer's Disease, Mild cognitive impairment, Outcomes, Systematic review, Qualitative, Quantitative, Quality of life, Memory
Epidemiology of dementia: prevalence and incidence estimates using validated electronic health records from primary care Ponjoan 2019 ROADMAP https://doi.org/10.2147/CLEP.S186590 Clinical research paper, family physician, accuracy, quality, positive predictive value, electronic medical record, real-world data
Measuring quality of life of people with predementia and dementia and their caregivers: a systematic review protocol Landeiro 2018 ROADMAP https://dx.doi.org/10.1136/bmjopen-2017-019082 Systematic review protocol, dementia, carers, quality of life, real world data
Resource utilisation and costs in predementia and dementia: a systematic review protocol Landeiro 2018 ROADMAP http://doi.org/10.1136/bmjopen-2017-019060 Systematic review protocol, dementia, carers, health and social care, cost
Systematic literature review of methodologies and data sources of existing economic models across the full spectrum of Alzheimer’s disease and dementia (...): a systematic review protocol. Karagiannidou 2018 ROADMAP http://dx.doi.org/10.1136/bmjopen-2017-020638 Systematic review protocol, Alzheimer's disease, dementia, economic modelling, health and social care
Regulatory and Health Technology Assessment Considerations for Disease-Modifying Drugs in Alzheimer’s Disease Bouvy 2018 ROADMAP https://doi.org/10.1007/s40263-018-0581-x Opinion paper, regulatory, HTA, Alzheimer's disease, real-world evidence, outcomes
Alignment of European regulatory and health technology assessments: a review of licensed product’s for Alzheimer’s disease Dekker 2019 ROADMAP https://doi.org/10.3389/fmed.2019.00073 Review article, health technology assessments, regulatory assessments, alignment, Alzheimer's disease, regulatory science
Ethical and social implications of using predictive modeling for Alzheimer’s disease prevention: a systematic literature review protocol Angehrn 2019 ROADMAP http://dx.doi.org/10.1136/bmjopen-2018-026468 Systematic review protocol, ethics, ELSI, Alzheimer's disease, progression modelling
Brain Amyloid Pathology and Cognitive Function Alzheimer Disease Without Dementia? Visser 2017 ROADMAP https://doi.org/10.1001/jama.2017.6895 Editorial, biomarker, amyloid, Alzheimer's disease, dementia, MRI, brain imaging
Real-world evidence in Alzheimer’s disease: The ROADMAP Data Cube Janssen 2019 ROADMAP https://doi.org/10.1016/j.jalz.2019.09.087 Alzheimer's disease, Real-world data, ROADMAP project, Outcomes, Stakeholders, Disease spectrum, Gap analysis
Ethical and Social Implications of Using Predictive Modeling for Alzheimer’s Disease Prevention: A Systematic Literature Review Angehrn 2020 ROADMAP https://doi.org/10.3233/JAD-191159 Ethic, Social, Implications, Systematic Literature Review, SLR, Predictive Modelling
Valuing Alzheimer's disease drugs: a health technology assessment perspective on outcomes Bauer 2020 ROADMAP https://doi.org/10.1017/S0266462320000574 HTA, Health technology assessment, outcome, literature review
Health outcome prioritisation in Alzheimer’s disease: Understanding the ethical landscape McKeown 2020 ROADMAP https://doi.org/10.3233/JAD-191300 Alzheimer’s disease, dementia, ethics, health priorities, Review
Obtaining EQ-5D-5L utilities from the disease specific quality of life Alzheimer’s disease scale: development and results from a mapping study Rombach 2020 ROADMAP https://doi.org/10.1007/s11136-020-02670-8 Mapping algorithm, Cross-walking, Health related quality of life, Preference based measures, Dementia
Health-related quality of life in people with predementia Alzheimer’s disease, mild cognitive impairment or dementia measured with preference-based instruments: a systematic literature review Landeiro 2020 ROADMAP https://alzres.biomedcentral.com/articles/10.1186/s13195-020-00723-1 Dementia, Alzheimer’s disease, Quality of life, Systematic literature review
Is it time to use real-world data from primary care in Alzheimer’s disease? Ponjoan 2020 ROADMAP https://doi.org/10.1186/s13195-020-00625-2 Family physician, Electronic medical records, Epidemiology, General practitioner, Dementia
Conducting public involvement in dementia research: The contribution of the European Working Group of People with Dementia to the ROADMAP project Diaz 2021 ROADMAP https://doi.org/10.1111/hex.13246 Alzheimer's disease, dementia, patient empowerment, patient engagement, patient involvement, public participation
Title Description Type Project  
EXAG Advisory Agreement Template

ROADMAP established the Expert Advisory Group (EXAG) to ensure the relevance and usability of ROADMAP activities and outputs to regulators and HTA agencies. For more information, please see:

https://roadmap-alzheimer.org/expert-advisory-group/

tools-regulators-roadmap-20 ROADMAP
Data Cube

ROADMAP’s Interactive Data Cube offers an overview of availability of European real-world data on Alzheimer’s disease (AD). The Data Cube can be seen as a three-dimensional ‘heat map’ to interactively visualise how European data sources capture relevant AD-related outcomes. It also provides an overview of the relevance of such outcomes for different disease stages, and for different types of stakeholders. ROADMAP’s Interactive Data Cube does not provide access to any underlying data for any of the different data sources. Its aim is to only provide high-level information about availability of such data, as provided by the data sources themselves. Interested parties should contact data sources directly. For more information, please visit:

Tool: https://datacube.roadmap-alzheimer.org/

Publication: https://www.sciencedirect.com/science/article/abs/pii/S1552526019354871

tools-rwe-roadmap-21 ROADMAP
Relevant functional outcomes for different stakeholder groups

ROADMAP identified the Alzheimer’s disease-relevant priority outcomes for different stakeholder groups (e.g. professionals working in dementia, people with dementia, caregivers) through systematic literature review, patient and public consultations, and stakeholder surveys. For more information, please see: 

https://roadmap-alzheimer.org/wp-content/uploads/2018/07/ROADMAP_D2.3D2.4.pdf

tools-rwe-roadmap-22 ROADMAP

 

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