Newcastle upon Tyne, February 05, 2019 – A new European research project to Identify Digital Endpoints to Assess FAtigue, Sleep and acTivities of daily living (acronym: IDEA-FAST) in the following neurodegenerative disorders (NDD): Parkinson’s disease and Huntington’s disease and in the following immune-mediated inflammatory diseases (IMID): rheumatoid arthritis, systemic lupus erythematosus, primary Sjögren’s syndrome, and inflammatory bowel disease; has been launched.
IDEA-FAST is a ground-breaking, €42 million digital health project co-funded by the European Union (represented by the European Commission) and the European pharmaceutical industry (represented by EFPIA, the European Federation of Pharmaceutical Industries and Associations) under the Innovative Medicines Initiative Joint Undertaking (IMI JU) programme. It consists of 46 members from 14 different European countries, including pharmaceutical companies, academic & not-for-profit institutions, small- and medium-sized enterprises and patient organisations aimed to play complementary roles in achieving the agreed goals.
Fatigue and sleep disturbances are common and disabling symptoms that affect patients with NDD and IMID, impacting on daily activities; they are the major causes 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.
Based on the advancement of wearable and portable digital technology, IDEA-FAST aims to address these issues by identifying novel digital endpoints for fatigue, sleep disturbances and disabilities in daily activities. The final ambitious goal is to provide more objective, sensitive, reliable and ecological measures of the severity and impact of these symptoms in real-world settings. Such digital endpoints will eventually improve the efficiency of clinical trials, ultimately reducing the time and cost to bringing new therapies to patients.
The project will run for 66 months, consisting of 2 phases: an initial pilot study for testing and prioritising several digital devices and to identify candidate digital endpoints, followed by a large longitudinal study to validate findings for the most promising digital endpoints. The project will seek advice from regulatory agencies, including EMA, for the initial qualification of these digital endpoints. Patient users’ perspective, data privacy, ethical, legal and other regulatory issues will be taken into consideration at all stages of the project.
About IDEA-FAST
IDEA-FAST is led by Newcastle University, Great Britain, and University Hospital Schleswig-Holstein, Kiel, Germany as academic co-leaders, and by Janssen Pharmaceutica NV and Takeda Pharmaceuticals International as industry co-leaders.
See https://idea-fast.eu/ for more details.
About the Innovative Medicines Initiative and the European Federation of Pharmaceutical Industries and Associations
IMI is Europe’s largest public-private initiative aiming to speed up the development of better and safer medicines for patients. IMI supports collaborative research projects and builds networks of industrial and academic experts in order to boost pharmaceutical innovation in Europe. IMI is a joint undertaking between the European Commission and EFPIA.
See https://www.imi.europa.eu/ and https://www.efpia.eu/ for more details.
Acknowledgment
This project has received funding from the Innovative Medicines Initiative 2 Joint Undertaking (JU) under grant agreement No 853981. The JU receives support from the European Union’s Horizon 2020 Research and Innovation Programme and EFPIA and Parkinson’s Disease Society of the United Kingdom LBG.
Disclaimer
This communication reflects the view of the IDEA-FAST Consortium and neither IMI nor the European Union and EFPIA are liable for any use that may be made of the information contained herein.
| Prof. Wan-Fai Ng Coordinator | Dr. Frédéric Baribaud Industry Lead |
| Prof. Walter Maetzler co-Coordinator | Dr. Manisha Madhoo Virgina Parks Industry co-Lead |
