This allows us to incorporate the views and knowledge of such stakeholders including patients, (clinical) researchers, healthcare providers, regulators, payers, Health Technology Assessment (HTA) groups, and ethics bodies. Representatives of these stakeholder groups have been invited to serve on the Trials@Home External Stakeholder Platform (ESP).
The (members of) the ESP will be consulted by the different work package teams several times per year to inform and provide expert feedback on key elements of the activities to ensure relevance, feasibility, attractiveness and practicability of project deliverables and create a sense of ‘co-ownership’ of the Trials@Home recommendations and findings, further promoting their future adoption. Concrete directions and guidelines will ensure that results have an immediate impact on drug development.
Trials@Home acknowledges the need to place patients at the centre of the research process, and has set-up a Patient Expert Panel (PEP) too, to promote meaningful engagement.
PEP Members are fully embedded in the Trials@Home project in the form of representation in all work packages and through additional ad-hoc consultations, and also work closely with the External Stakeholder Platform (ESP). PEP members provide advice, insights and inputs to ensure that the experiences, needs and perspectives of people living with diabetes (the therapeutic area of the pilot project) are reflected at all stages of the research process and during the dissemination phase. The PEP also acts as a resource for all project beneficiaries as well as, as appropriate, for specific external parties, such as regulatory authorities.