Challenge

Patients with neurodegenerative disorders (NDDs) and immune-mediated inflammatory diseases (IMIDs) often suffer from fatigue, sleep disturbances, and difficulties with activities of daily living (ADLs), all of which significantly reduce their quality of life. Current assessments of these symptoms primarily rely on infrequent, subjective patient-reported outcomes (PROs), which are prone to recall bias and lack sensitivity to change. Furthermore, these assessments are not suitable for capturing real-life variability, especially in patients with cognitive or affective impairments. This creates a major barrier to early intervention and therapeutic development. There is a need for more objective, sensitive, and continuous methods to evaluate fatigue, sleep, and ADLs in these patient groups.

Solutions

IDEA-FAST addresses this challenge by identifying and validating digital endpoints-objective measures derived from digital devices-that can assess fatigue, sleep quality, and ADLs. These endpoints are developed using a combination of active self-reports (ePROs) and passive data from wearable sensors to capture behavioural and physiological patterns in real-life environments. The project involves designing and conducting a feasibility study followed by a large-scale Clinical Validation Study. It includes the development of a secure, interoperable digital platform for data management, integration of large datasets, and rigorous evaluation of digital solutions. The project will also engage with regulatory agencies (EMA/FDA) to seek advice on qualifying these digital endpoints for clinical use.

Results

IDEA-FAST is expected to revolutionize how fatigue, sleep, and daily functioning are monitored in clinical research and healthcare. By replacing subjective, infrequent PROs with validated, objective, and continuous digital endpoints, the project will improve early detection of health deterioration, enable personalized care, and support the development of new treatments. The availability of a large, longitudinal real-world dataset will provide a valuable resource for future academic and industrial research. Furthermore, the project’s engagement with regulators and HTAs could pave the way for the formal acceptance of digital endpoints in drug development and health assessments. Ultimately, this will enhance patient care, accelerate innovation, and contribute to better health outcomes and societal well-being.