Bando: H2020-JTI-IMI2-2018-15-two stage
Ruolo: Partner
Responsabile per UniBS: Dott. Andrea Pilotto – Dipartimento di Scienze Cliniche e Sperimentali
Contatto: andrea.pilotto@unibs.it
Data inizio 01/11/2019 – Data fine 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.
Partecipanti:
- UNIVERSITY OF NEWCASTLE UPON TYNE, Coordinatore (Regno Unito)
- UNIVERSITATSKLINIKUM SCHLESWIG-HOLSTEIN (Germania)
- UNIVERSITA’ DEGLI STUDI DI BRESCIA (Italia)
- ERASMUS UNIVERSITAIR MEDISCH CENTRUM ROTTERDAM (Paesi Bassi)
- UNIVERSITY OF GLASGOW (Regno Unito)
- UNIVERSITY OF LIMERICK (Irlanda)
- ECRIN EUROPEAN CLINICAL RESEARCH INFRASTRUCTURE NETWORK (Francia)
- QUEEN MARY UNIVERSITY OF LONDON (Regno Unito)
- IMPERIAL COLLEGE OF SCIENCE TECHNOLOGY AND MEDICINE (Regno Unito)
- BYTEFLIES (Belgio)
- DREEM (Francia)
- THE CHANCELLOR MASTERS AND SCHOLARS OF THE UNIVERSITY OF CAMBRIDGE (Regno Unito)
- LIXOFT SAS (Francia)
- ASOCIACION PARKINSON MADRID (Spagna)
- STICHTING MLC FOUNDATION (Paesi Bassi)
- TMF – TECHNOLOGIE UND METHODENPLATTFORM FUR DIE VERNETZTE MEDIZINISCHE FORSCHUNG EV (Germania)
- MEDIBIOSENSE LTD (Regno Unito)
- EMPIRICA GESELLSCHAFT FUR KOMMUNIKATIONS UND TECHNOLOGIEFORSCHUNG MBH (Germania)
- FCIENCIAS.ID – ASSOCIACAO PARA A INVESTIGACAO E DESENVOLVIMENTO DE CIENCIAS (Portogallo)
- PLURIBUS ONE SRL (Italia)
- INSTITUTO DE MEDICINA MOLECULAR JOAO LOBO ANTUNES Portugal
- Teknologian tutkimuskeskus VTT Oy Finland
- Cambridge Cognition LTD (Regno Unito)
- UNIVERSIDAD AUTONOMA DE MADRID (Spagna)
- INSTITUT MINES-TELECOM (Francia)
- MCROBERTS BV (Paesi Bassi)
- GEORGE-HUNTINGTON-INSTITUT GMBH (Germania)
- INSTYTUT PSYCHIATRII I NEUROLOGII (Polonia)
- MEDIZINISCHE UNIVERSITAT INNSBRUCK (Austria)
- HELSE STAVANGER HF (Norvegia)
- IXSCIENT LIMITED (Regno Unito)
- EUROPEAN FEDERATION OF CROHN’S AND ULCERATIVE COLITIS ASSOCIATIONS (Belgio)
- ACADEMISCH ZIEKENHUIS LEIDEN (Paesi Bassi)
- THE UNIVERSITY OF MANCHESTER (Regno Unito)
- JANSSEN PHARMACEUTICA NV (Belgio)
- TAKEDA PHARMACEUTICALS INTERNATIONAL AG (Svizzera)
- ABBVIE INC (Stai Uniti)
- ASTRAZENECA AB (Svezia)
- CHDI Foundation, Inc. (Stati Uniti)
- Eli Lilly and Company Limited (Regno Unito)
- PARKINSON’S DISEASE SOCIETY OF THEUNITED KINGDOM LBG (Regno Unito)
- PFIZER LIMITED (Regno Unito)
- F. HOFFMANN-LA ROCHE AG (Svizzera)
- SANOFI-AVENTIS RECHERCHE & DEVELOPPEMENT (Francia)
- UCB BIOPHARMA SPRL (Belgio)
- BIOGEN IDEC LIMITED (Regno Unito)
- ORION OYJ (Finlandia)
Costo totale progetto/contributo UE: € 20.997.522,50
Totale finanziamento per UniBS: € 344.500,00