Projects
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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 |
| Logo |  |
| Name | Projects | Type of institution | Country | |
|---|---|---|---|---|
| Synapse Research Management Partners SL | EPAD AMYPAD NEURONET EMIF ROADMAP | SME | Spain | |
| 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 | |
| University Of Edinburgh | EPAD AMYPAD EQIPD ROADMAP | Academia | United Kingdom | |
| 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 | |
| Erasmus Universitair Medisch Centrum Rotterdam | PRISM ADAPTED AETIONOMY EMIF ROADMAP EPAD IDEA-FAST | Academia | Netherlands | |
| GE healthcare Ltd | AMYPAD ROADMAP | EFPIA | United Kingdom | |
| Aarhus Universitet | IMPRiND IM2PACT ROADMAP EMIF | Academia | Denmark | |
| Academisch Ziekenhuis Leiden | PRISM IM2PACT ROADMAP IDEA-FAST PRISM2 | Academia | Netherlands | |
| 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 | |
| Goeteborgs Universitet | PHAGO ROADMAP EMIF EPND | Academia | Sweden | |
| Kobenhavns Universitet | IM2PACT ROADMAP EMIF | Academia | Denmark | |
| London School Of Economics And Political Science | ROADMAP | Academia | United Kingdom | |
| Rijksuniversiteit Groningen | PRISM EQIPD ROADMAP PRISM2 | Academia | Netherlands | |
| Universiteit Maastricht | ROADMAP EMIF EPND | Academia | Netherlands | |
| University Of Oxford | EPAD IMPRiND IM2PACT RADAR-AD ROADMAP EMIF EPND | Academia | United Kingdom | |
| IXICO Technologies LTD | AMYPAD ROADMAP EPAD | SME | United Kingdom | |
| 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 | |
| Health economic modeling for Alzheimer's disease: Expert perspectives | Landeiro | 2022 | ROADMAP | https://doi.org/10.1002%2Ftrc2.12360 | Alzheimer's disease, costs, dementia, disease‐modifying treatment, economic models, model structure, pre‐dementia, quality‐adjusted life years, quality of life |
| 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: |
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 |
| Website: https://roadmap-alzheimer.org/ |
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