01 University of Newcastle Upon Tyne (UK)

Newcastle University (UNEW) is a thriving international community of 2,400 academic staff, as well as 28,000 undergraduate and postgraduate students from over 140 countries worldwide.

Due to its background of holding and leading multiple centres and institutes and projects in biomedical field, the profile of UNEW clearly matches the multidisciplinary expertise and leadership that is required in IDEA-FAST. In IDEA-FAST, UNEW will work with the Newcastle upon Tyne Hospitals NHS Foundation Trust (NUTH, linked third party) to deliver the project. The UNEW-NUTH partnership comprises both clinical and non-clinical scientists who together maintain an extensive translational research programme.

The current research strategy and vision for UNEW highlights ageing and health as a primary activity area in which their great potential in research excellence, creativity and striving for discovery and tangible impact will be put to use to deliver world-leading research from Newcastle for the world, aligning well with the aim and scope of this project.

Main tasks in the project

UNEW’s main tasks are as follows:

  • Coordinate the overall project, working with Industry Lead (Janssen), Industry co-lead (TAK) , Project co-coordinator (UKSH) and Project Manager, IXS (WP1).
  • In WP2, UNEW will lead Task 2.2 (Provide clinical insights to the selection of the most promising technologies and to the help to design of the clinical validation study) and co-lead Task 2.45 with TAK (Provide clinical insight to support engagement with regulatory agencies). In addition, UNEW/NUTH will also take part as a clinical site in the feasibility study.
  • In WP3, UNEW will provide overall leadership of the WP and facilitate the device selection process (Task 3.1), support application consolidation, design and development for sensor data consolidation, pre-processing and for patient engagement (Task 3.2), as well as lead the implementation of a unified support & knowledge centre for device / application use during the project (Task 3.3). This engagement in WP3 includes the formation of – and active participation in – a Task Force for Technology Integration (TFTI) for close cross-WP interaction between WPs 2,3,4 and 5 (adding 7 and 8 for additional guidance). It also includes the technology informed shaping of the application of participatory design and user engagement methods to accurately reflect patient (and professional user) requirements and experience in device selection and application development, as well as for the feasibility study.
  • In WP4, UNEW will contribute to identifying candidate device-specific digital endpoints (Task 4.1), with a focus on accelerometer and mobile data analysis from data pre-processing, (device-specific) feature extraction, to evaluation and visualization on understanding the relationship between the candidate endpoints to sleep/fatigue (Tasks 4.2 and 4.3). [Note this work overlap with WP7 and staff effort allocated to WP7]
  • In WP6, UNEW will work closely with all clinical partners, patient advisory board and relevant patient organisations, to ensure effective setup (Task 6.1) and coordination (Task 6.2), as well as leading on recruitment and retention of participants in the clinical validation study (Task 6.3).
  • In WP7, UNEW will contribute to the developing an AI toolbox for robust multi-variate time-series analysis, which plays a key role in mapping the information collected from the digital devices to the ePRO on realizing objective sleep/fatigue assessment. It will also show the contribution of each device, from which the optimal trade-off between usability and accuracy can be found (i.e. identifying the most suitable digital endpoints). UNEW will also support the development of personalised disease models (Task 7.3) and data analytics packages (Task 7.4).
  • In WP9, UNEW will contribute to the organisation of workshops and events related to project achievements (Task 9.1), support the ongoing development of impact-oriented exploitation and sustainability plans (Task 9.2), inform the healthcare system impact analysis and estimations for the UK (Task 9.3) and contribute to the “Regulatory issues and HTA engagement” (Task 9.3).

In addition, the main roles of NUTH are to:

  1. Facilitate patient recruitment for the Feasibility study (WP2) and the Clinical Validation Study (WP6).
  2. Act as Sponsor of Feasibility Study for the recruitment of Rheumatoid arthritis, lupus and primary Sjogren’s syndrome patients (WP2) to be carried out in the Newcastle Clinical Research Facility.

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