Call: H2020-JTI-IMI2-2018-15-two stage
Role: Partner
Responsible for UniBS: Dr. Andrea Pilotto – Department of Clinical and Experimental Sciences
Contact: andrea.pilotto@unibs.it
Start date 01/11/2019 – End date 30/04/2025
Abstract
Fatigue and sleep disturbances are two common and disabling symptoms that affect patients with neurodegenerative disorders (NDD) and immune-mediated inflammatory diseases (IMID). These symptoms are major predictors of poor quality of life and increased healthcare cost. Current questionnaire-based approaches to measure these symptoms have key limitations preventing them from being used as reliable endpoints in clinical trials to evaluate the effect of therapies.
IDEA-FAST aims to address these issues by identifying novel digital endpoints for fatigue and sleep disturbances that will provide more objective, sensitive and reliable measures of the severity and impact of these symptoms in ecological settings. Such digital endpoints will not only help to gain insight into the underpinning mechanisms of fatigue and sleep disturbances, but will also vastly improve the efficiency of clinical trials, ultimately reducing the time and cost to bring new therapies to patients.
To identify these digital endpoints, we will follow the recommendations of the Clinical Trials Transformation Initiative (CTTI). We will identify the characteristics that fatigue and sleep disturbances will have impact, then select the digital measures (endpoints) to quantify them, followed by choosing the appropriate digital device/technology accordingly. We will then perform a pilot study to prioritise a few of these candidate digital endpoints for validation. We will test the performance of these digital endpoints in two NDD and four IMID in a large longitudinal study during which extensive relevant clinical data will be collected. If these digital endpoints were validated, we will seek support from EMA/FDA for their qualification. Patient users’ perspective, ethical, data privacy, legal and other regulatory issues will be taken into consideration in all aspects of our proposal.
The resultant digital biobank from the longitudinal study will become an invaluable resource for future exploitation.
Partners:
- UNIVERSITY OF NEWCASTLE UPON TYNE, Coordinator (United Kingdom)
- UNIVERSITATSKLINIKUM SCHLESWIG-HOLSTEIN (Germany)
- UNIVERSITA’ DEGLI STUDI DI BRESCIA (Italy)
- ERASMUS UNIVERSITAIR MEDISCH CENTRUM ROTTERDAM (Netherlands)
- UNIVERSITY OF GLASGOW (United Kingdom)
- UNIVERSITY OF LIMERICK (Ireland)
- ECRIN EUROPEAN CLINICAL RESEARCH INFRASTRUCTURE NETWORK (France)
- QUEEN MARY UNIVERSITY OF LONDON (United Kingdom)
- IMPERIAL COLLEGE OF SCIENCE TECHNOLOGY AND MEDICINE (United Kingdom)
- BYTEFLIES (Belgium)
- DREEM (France)
- THE CHANCELLOR MASTERS AND SCHOLARS OF THE UNIVERSITY OF CAMBRIDGE (United Kingdom)
- LIXOFT SAS (France)
- ASOCIACION PARKINSON MADRID (Spain)
- STICHTING MLC FOUNDATION (Netherlands)
- TMF – TECHNOLOGIE UND METHODENPLATTFORM FUR DIE VERNETZTE MEDIZINISCHE FORSCHUNG EV (Germany)
- MEDIBIOSENSE LTD (United Kingdom)
- EMPIRICA GESELLSCHAFT FUR KOMMUNIKATIONS UND TECHNOLOGIEFORSCHUNG MBH (Germany)
- FCIENCIAS.ID – ASSOCIACAO PARA A INVESTIGACAO E DESENVOLVIMENTO DE CIENCIAS (Portugal)
- PLURIBUS ONE SRL (Italy)
- INSTITUTO DE MEDICINA MOLECULAR JOAO LOBO ANTUNES (Portugal)
- Teknologian tutkimuskeskus VTT Oy (Finland)
- Cambridge Cognition LTD (United Kingdom)
- UNIVERSIDAD AUTONOMA DE MADRID (Spain)
- INSTITUT MINES-TELECOM (France)
- MCROBERTS BV (Netherlands)
- GEORGE-HUNTINGTON-INSTITUT GMBH (Germany)
- INSTYTUT PSYCHIATRII I NEUROLOGII (Poland)
- MEDIZINISCHE UNIVERSITAT INNSBRUCK (Austria)
- HELSE STAVANGER HF (Norway)
- IXSCIENT LIMITED (United Kingdom)
- EUROPEAN FEDERATION OF CROHN’S AND ULCERATIVE COLITIS ASSOCIATIONS (Belgium)
- ACADEMISCH ZIEKENHUIS LEIDEN (Netherlands)
- THE UNIVERSITY OF MANCHESTER (United Kingdom)
- JANSSEN PHARMACEUTICA NV (Belgium)
- TAKEDA PHARMACEUTICALS INTERNATIONAL AG (Switzerland)
- ABBVIE INC (United States)
- ASTRAZENECA AB (Sweden)
- CHDI Foundation, Inc. (United States)
- Eli Lilly and Company Limited (United Kingdom)
- PARKINSON’S DISEASE SOCIETY OF THEUNITED KINGDOM LBG (United Kingdom)
- PFIZER LIMITED (United Kingdom)
- F. HOFFMANN-LA ROCHE AG (Switzerland)
- SANOFI-AVENTIS RECHERCHE & DEVELOPPEMENT (France)
- UCB BIOPHARMA SPRL (Belgium)
- BIOGEN IDEC LIMITED (United Kingdom)
- ORION OYJ (Finland)
Overall budget/EU contribution: € 20,997,522.50
UniBS overall budget: € 344,500.00