The IDEA-FAST project is a 5½-year IMI2 project under Call H2020-JTI-IMI2-2018-15-two-stage – digital endpoints in neurodegenerative and immune-mediated diseases (total budget €42 Million) that starts in November 2019, run by a consortium of 46 partners across 15 countries in Europe. It received funding from the Innovative Medicines Initiative 2 Joint Undertaking under grant agreement No 853981. This Joint Undertaking receives support from the European Union’s Horizon 2020 research and innovation program and EFPIA and PARKINSON’S DISEASE SOCIETY OF THE UNITED KINGDOM LBG.
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).
For patients with chronic diseases such as neurodegenerative disorders (NDD) and immune-mediated inflammatory diseases (IMID), a key attribute for any successful therapeutic intervention is its ability to improve the patients’ activities of daily living (ADL) and health-related quality of life (HRQoL). Current evaluations of ADL and HRQoL rely mainly on subjective reports, typically using standardized questionnaires provided by patients every few months. The approach is often prone to recall bias, reliability issues and poor sensitivity to change. IDEA-FAST wants to change this!
Selection of 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.
Implementation of 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).
Establishing 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.
Evaluating 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 the EMA and FDA, and to obtain opinion about the role of these endpoints in supporting health utility evaluation by Health Technology Agencies (HTA).
Ensuring 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.
Identifying Digital Endpoints to Assess Fatigue, Sleep and Activities of Daily Living in Neurodegenerative Disorders and Immune-mediated Inflammatory Diseases
Innovative Medicines Initiative 2 Joint Undertaking
IMI2-2018-15-06 – Digital endpoints in neurodegenerative and immune-mediated diseases
+ €21 Million EFPIA partners contributions
November 2019 – April 2025