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!
The goal is to identify, profile and validate digital solutions based on mobile or residential technology for remote assessment of fatigue and sleep disturbances that could effectively be used as digital endpoints in assessments for RA, SLE, PSS, IBD, PD, HD and beyond. Identifying digital endpoints for fatigue and sleep disturbances that can be used in patients’ usual living environment will also enable the meaningful evaluation of impacts of these symptoms on ADL/HRQoL. The ecological validity of these digital endpoints will be tested using a large longitudinal cohort of four IMID and two NDD.
- Identify and select a set of digital endpoints and corresponding digital devices/technologies
- Build a digital management platform
- Establish a large and well-characterised longitudinal cohort of patients
- Run a (1) feasibility and (2) clinical validation study
- Receive scientific advice from EMA for the future use of digital endpoints in clinical trials
- Novel clinically validated digital endpoints for fatigue, sleep disturbances and other ADL/HRQoL
- More valid and complete assessment of the impact of diseases and treatments
- Reduced patient burden, improved patient centred and personalised care
- Better clinical management
- Deeper insight into disease impact and afflictions
- Larger and more inclusive clinical trials, faster clinical development of new therapies
- Lasting impact through high quality data set on fatigue and sleep disturbances
- The development and clinical validation of IDEA-FAST digital endpoints, together with the associated integrated digital and clinical data set, will put Europe at the forefront of this field and enable the growth of a significant new worldwide market sector