The Identify Digital Endpoints to Assess FAtigue, Sleep and acTivities of daily living (IDEA-FAST) is a ground-breaking project, funded by the European Union and the European pharmaceutical industry, under the Innovative Medicines Initiative Joint Undertaking programme.

Medical conditions, such as Parkinson’s disease, Huntington’s disease, rheumatoid arthritis, lupus, Sjögren's syndrome and inflammatory bowel disease, are the focus of the research.

European collaboration

IDEA-FAST consists of 46 members from 14 different European countries including pharmaceutical companies, academic and not-for-profit institutions, small and medium-sized enterprises, and patient organisations which will each play complementary roles in achieving the agreed goals.

Fatigue and sleep disturbances are common and disabling symptoms that affect patients with neurodegenerative and inflammatory diseases. They impact on daily activities and are the major causes of patients’ 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.

Fai Ng, Professor of Rheumatology at Newcastle University’s Faculty of Medical Sciences, and a consultant at Newcastle Hospitals NHS Foundation Trust, is leading the European consortium.

He said: “IDEA-FAST will revolutionise the way that we assess the real burden of fatigue and sleep disturbance in many chronic diseases accurately and reliably in the real world.

“The project will transform how we conduct clinical trials and further consolidate our world-leading reputation in translational research in long-term conditions."

The final ambitious goal of IDEA-FAST is to provide more objective, sensitive, reliable and ecological measures of the severity and impact of 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 more than five years and will consist of two phases. An initial pilot study for testing and prioritising several digital devices and to identify candidate digital endpoints will be followed by a large longitudinal study to validate findings for the most promising digital endpoints.

The project will seek advice from regulatory agencies, including the European Medicines Agency, 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 and University Hospital Schleswig-Holstein, Kiel, Germany, as academic co-leaders, and by Janssen Pharmaceutica NV and Takeda Pharmaceuticals International as industry co-leaders.

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.