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Name IDEA-FAST
Long Name Identifying digital endpoints to assess fatigue, sleep and activities in daily living in neurodegenerative disorders and immune-mediated inflammatory diseases
Description Identifying digital endpoints to assess fatigue, sleep and activities in daily living in neurodegenerative disorders and immune-mediated inflammatory diseases. IDEA-FAST aims to identify digital endpoints that provide reliable, objective and sensitive evaluation of activities of daily life (ADL), disability and health related-quality of life (HRQoL) for the following neurodegenrative diseases (NDD): Parkinson’s Disease (PD), Huntington’s Disease (HD) and the following immune-mediated inflammatory diseases (IMID): Rheumatoid Arthritis (RA), Systemic Lupus Erythematosus (SLE), Primary Sjögren’s Syndrome (PSS), and Inflammatory Bowel Disease (IBD).
Objectives 1. Select a set of digital endpoints and corresponding digital devices/technologies for the evaluation of fatigue and sleep disturbances for clinical validation, and to explore digital correlates of other ADLs by profiling activity, biological, neurocognitive and behavioural aspects in patients with IBD, RA, SLE, PSS, PD and HD. 2. Implement a robust, seamless, interoperable and secure digital management platform that is compliant with legal and data privacy requirements to support data acquisition, storage, analysis of patient and professional information; and to define standards for data integration, analysis, storage and sharing (including secondary use of data to maximise impact and exploitation). 3. Establish a large and well-characterised longitudinal cohort of IBD, RA, SLE, PSS, PD and HD patients with detailed records about the candidate digital endpoints described in objective 1. 4. Evaluate the clinical validity of the candidate digital endpoints compared to gold standards, and to seek qualification advice of their use as novel digital endpoints by regulatory agencies such as EMA, and to obtain opinion about the role of these endpoints in supporting health utility evaluation by Health Technology Agencies (HTA). 5. Ensure a lasting impact through the creation of a properly annotated database compatible with the International Classification of Functioning, Disability, and Health (ICF) which will include real-world digital datasets of biophysiological, neurocognitive, behavioural, personal, environmental and socialization observations coupled with comprehensive clinical data to support the possible finalization of the regulatory qualification process to foster future academic and industrial studies aimed to develop novel treatments.
Website https://ideafast.eu/
Start date 01-11-2019
End date 30-04-2025
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Name Projects Type of institution Country  
Abbvie Inc. EQIPD IDEA-FAST EFPIA United States
Astrazeneca AB MOPEAD PHAGO Mobilise-D IDEA-FAST PD-MIND Pharma-Cog EFPIA Sweden
Biogen Idec Limited EPAD RADAR-CNS ROADMAP ADAPTED IDEA-FAST EFPIA United Kingdom
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
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
Orion Oyj EQIPD PHAGO IDEA-FAST EFPIA Finland
Pfizer Limited EPAD EQIPD EMIF IM2PACT PRISM Mobilise-D IDEA-FAST EFPIA United Kingdom
Sanofi-Aventis Recherche & Developpement EPAD EQIPD AETIONOMY IM2PACT PHAGO NEURONET Mobilise-D IDEA-FAST EPND EFPIA France
UCB Biopharma SPRL EPAD EQIPD AETIONOMY EMIF PD-MitoQUANT RADAR-CNS IDEA-FAST Pharma-Cog EPND EFPIA Belgium
Academisch Ziekenhuis Leiden PRISM IM2PACT ROADMAP IDEA-FAST PRISM2 Academia Netherlands
Ecrin European Clinical Research Infrastructure Network IDEA-FAST Academia France
Erasmus Universitair Medisch Centrum Rotterdam PRISM ADAPTED AETIONOMY EMIF ROADMAP EPAD IDEA-FAST Academia Netherlands
Fciencias.Id - Associacao Para A Investigacao E Desenvolvimento De Ciencias IDEA-FAST Academia Portugal
Helse Stavanger Hf IDEA-FAST PD-MIND Academia Norway
Imperial College Of Science Technology And Medicine EQIPD Mobilise-D IDEA-FAST Academia United Kingdom
Institut Mines-Telecom IDEA-FAST Academia France
Instituto De Medicina Molecular Joao Lobo Antunes IDEA-FAST Academia Portugal
Instytut Psychiatrii I Neurologii IDEA-FAST Academia Poland
Medizinische Universitat Innsbruck IDEA-FAST Academia Austria
Queen Mary University Of London IDEA-FAST Academia United Kingdom
Teknologian Tutkimuskeskus VTT Oy EMIF IDEA-FAST Academia Finland
The University Of Manchester IDEA-FAST Academia United Kingdom
Tmf - Technologie Und Methodenplattform Fur Die Vernetzte Medizinische Forschung Ev IDEA-FAST Academia Germany
Universidad Autonoma de Madrid IDEA-FAST Academia Spain
Universita Degli Studi Di Brescia IDEA-FAST Academia Italy
Universitätsklinikum Schleswig-Holstein EMIF IDEA-FAST Academia Germany
University Of Glasgow EMIF IDEA-FAST Academia United Kingdom
University Of Limerick IDEA-FAST Academia Ireland
University Of Newcastle Upon Tyne Mobilise-D IDEA-FAST Academia United Kingdom
University Of Cambridge EPAD IMPRiND PHAGO EMIF IDEA-FAST Academia United Kingdom
Byteflies IDEA-FAST SME Belgium
Cambridge Cognition Ltd EMIF IDEA-FAST SME United Kingdom
Dreem IDEA-FAST SME France
Empirica Gesellschaft Fur Kommunikations Und Technologieforschung Mbh IDEA-FAST SME Germany
George-Huntington-Institut GMBH IDEA-FAST SME Germany
Ixscient Limited, Uxbridge Mobilise-D IDEA-FAST SME United Kingdom
Lixoft SAS IDEA-FAST SME France
McRoberts BV Mobilise-D IDEA-FAST SME Netherlands
Medibiosense LTD IDEA-FAST SME United Kingdom
Pluribus One SRL IDEA-FAST SME Italy
Stichting Mlc Foundation IDEA-FAST SME Netherlands
Asociacion Parkinson Madrid IDEA-FAST Patient/carers organisation Spain
European Federation Of Crohn's And Ulcerative Colitis Associations IDEA-FAST Patient/carers organisation Belgium
Parkinson's Disease Society Of The United Kingdom LBG NEURONET PD-MitoQUANT IDEA-FAST PD-MIND Patient/carers organisation United Kingdom
Christian-Albrechts-Universitaet Zu Kiel Mobilise-D IDEA-FAST Academia Germany
Faculdade De Ciencias Da Universidade De Lisboa IDEA-FAST Academia Portugal
Greater Glasgow Health Board IDEA-FAST Academia United Kingdom
Kks-Netzwerk Ev -Netzwerk Der Koordinierungszentren Fur Klinische Studien IDEA-FAST Academia Germany
CHDI Foundation, Inc. IDEA-FAST Academia United States
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 Oversight IDEA-FAST
WP2 Clinical Knowledge and Insight IDEA-FAST
WP3 Digital Device and Technology IDEA-FAST
WP4 Device-specific Data Analytics and Performance Assessment IDEA-FAST
WP5 Data Management IDEA-FAST
WP6 Clinical Study Organisation & Management IDEA-FAST
WP7 Statistical Inference Design and Learning IDEA-FAST
WP8 Data Protection, Ethics and Legal Challenges IDEA-FAST
WP9 Dissemination, Exploitation & Sustainability IDEA-FAST
Deliverable number Title Project Submission date Link Keywords  
D1.1 Project Handbook IDEA-FAST 27-03-2020 https://idea-fast.eu/wp-content/uploads/2020/10/IDEA-FAST_D1.1_Project-Handbook_v1.0-IMI.pdf
D1.2 Risk assessment process and management procedure IDEA-FAST 21-10-2020 https://idea-fast.eu/wp-content/uploads/2020/10/IDEA-FAST_D1.2_Risk-Assessment_v1.0.pdf
D2.1 First study subject approvals package of the Feasibility Study (FS) IDEA-FAST 31-07-2020 https://idea-fast.eu/wp-content/uploads/2020/10/IDEA-FAST_D2.1_FS-Approvals_v1.0_IMI.pdf
D3.1 Device Selection Criteria and Documents / Processes for Gathering Evidence IDEA-FAST 31-03-2020 https://idea-fast.eu/wp-content/uploads/2020/10/IDEA-FAST_D3.1_DeviceSelectionCriteriaAndDocuments_v1.pdf
D5.1 Data Management Plan IDEA-FAST 31-03-2020 https://idea-fast.eu/wp-content/uploads/2020/10/D5.1-IDEA-FAST_DMP_v10.pdf
D8.2 The model informed consent for the FS IDEA-FAST 31-03-2020 https://idea-fast.eu/wp-content/uploads/2022/01/IDEA-FAST_D8.2-Model-Informed-Consent-for-the-CVS_V1.0.pdf
D9.1 Detailed Dissemination Plan IDEA-FAST 29-05-2020 https://idea-fast.eu/wp-content/uploads/2020/10/D9.1-Dissemination-Plan-V1.0.pdf
D5.2 Specification of IDEA-FAST DMP IDEA-FAST 30-10-2020 https://ec.europa.eu/research/participants/documents/downloadPublic?documentIds=080166e5d54ee72b&appId=PPGMS
D4.1 Definition of assessment protocol for device-specific digital endpoints IDEA-FAST 06-10-2020 https://ec.europa.eu/research/participants/documents/downloadPublic?documentIds=080166e5d459bc85&appId=PPGMS
D2.4 Mid-term recruitment report of the feasibility study (FS) IDEA-FAST 05-01-2021 https://ec.europa.eu/research/participants/documents/downloadPublic?documentIds=080166e5d7b421aa&appId=PPGMS
D5.4 Public version of IDEA-FAST clinical and sensor data standards IDEA-FAST 08-12-2021 https://idea-fast.eu/wp-content/uploads/2022/01/IDEA-FAST_D5.4_Data_Standards_V1.0.pdf
D6.1 First version of the CVS protocol IDEA-FAST 18-10-2021 https://idea-fast.eu/wp-content/uploads/2022/01/IDEA-FAST_D6.1_CVS-Protocol_V1.0_IMI.pdf
D8.1 The model informed consent for the FS IDEA-FAST 31-03-2020 https://idea-fast.eu/wp-content/uploads/2021/01/IDEA-FAST_D8.1-Model-Informed-Consent-for-the-FS-V1.pdf
D4.4 Requirements specification data analytics software package IDEA-FAST 31-12-2021 https://idea-fast.eu/wp-content/uploads/2022/04/IDEA-FAST_D4.4_RequirementsSpecificationDataAnalyticsSW_V1.0.pdf
D6.2 Finalised master documents in English for ethical/regulatory submissions, including study protocol & PIS/ICF for the COS IDEA-FAST 09-05-2022 https://idea-fast.eu/wp-content/uploads/IDEA-FAST_D6.2_Finalised-Master-Documents_V1.0_IMI.pdf
D9.2 Definitions of the exploitation and socio- economic evaluation framework IDEA-FAST 13-05-2022 https://idea-fast.eu/wp-content/uploads/IDEA-FAST_D9.2_Exploitationsocio-economic-evaluation-framework_V1.0.pdf
D2.4 Report factors identified by historical data of published data IDEA-FAST 25-11-2021 https://ec.europa.eu/research/participants/documents/downloadPublic?documentIds=080166e5e17bd000&appId=PPGMS
Title First author last name Year Project Link Keywords  
Making Sense of Sleep: Multimodal Sleep Stage Classification in a Large, Diverse Population Using Movement and Cardiac Sensing Zhai 2020 IDEA-FAST https://doi.org/10.1145/3397325
Data Contribution Summaries for Patient Engagement in Multi-Device Health Monitoring Research Rainey 2021 IDEA-FAST https://doi.org/10.1145/3460418.3479371 digital health, human-centered design, in-the-wild studies, wearables, sensing devices, patient engagement, human-data interaction
A blockchain-based trust system for decentralised applications: When trustless needs trust Truong 2021 IDEA-FAST https://doi.org/10.1016/j.future.2021.05.025 Blockchain, DApps, Decentralised ecosystem, Reputation, Trust system
Privacy preservation in federated learning: An insightful survey from the GDPR perspective Truong 2021 IDEA-FAST https://doi.org/10.1016/j.cose.2021.102402 Federated learning, Data protection regulation, GDPR, Personal data, Privacy, Privacy preservation
Symbolic AI for XAI: Evaluating LFIT Inductive Programming for Explaining Biases in Machine Learning Ortega 2021 IDEA-FAST https://doi.org/10.3390/computers10110154 explainable artificial intelligence; inductive logic programming; fair recruitment; fair income level; propositional logic
Title Description Type Project  
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