WP2 provides the critical clinical knowledge and patient insight needed to deliver all project objectives. The WP2 leadership will coordinate a Clinical Knowledge and Insight Task Force (CKI-TF) that will include: (i) patient partners; (ii) digital technology experts from WP3 and WP4; (iii) clinical/scientific experts in fatigue, sleep, mood, psychology, epidemiology, statistics and patient/public engagement, several of them from EFPIA partners. The CKITF will guide the clinical aspects for the design and implementation of digital solutions progressed by WP3 and WP4, participate in the selection of candidate digital endpoints for the CVS and provide clinical expertise to support the achievement of other WPs deliverable. WP2 membership will reflect a strong patient-centric element to inform the design of clinical studies, interpretation of results and engagement with regulatory authorities. WP2 is also responsible for the design, organisation and execution of the Part A FS and for the design, supervision and result interpretation of the CVS. WP2 is also providing clinical expertise and strategic direction for the digital device selection for the CVS, the preparation and participation to the EMA and FDA meetings, the support for HTA and payer interaction as well as for the sustainability plan. UCAM will develop the patient-facing, interactive online portal and integrated clinical operational database to support the FS and the CVS. The design of the clinical studies is enclosed in the Clinical Study Document and describe the initial view of this work.
Objectives
O2.1 Design and implement the Feasibility Study
O2.2 Provide clinical insights to the selection of the most promising technologies and in the design of the Clinical Validation Study
O2.3 Provide clinical insights to the data analysis of the clinical studies and the preparation of the final Data Analytic Package for submission to Regulatory Agencies EMA ± FDA for scientific advice
O2.4 Understand the perspectives of different stakeholders including patients involved in the studies to inform strategies of future application of the digital endpoints
Deliverables
D2.1 First study subject approvals package of the FS
D2.2 Development of the prototype of clinical operation data management system for the FS
D2.3 Development of a patient-facing secure online portal
D2.4 Midterm recruitment report of the FS
D2.5 Development of the final version of clinical operation data management system for the CVS
D2.6 ‘Report on status of posting results’ of the FS
D2.7 Final review of clinical interpretation of DAP for EMA interaction
