About us

What is Trials@Home?

Centre of Excellence for Decentralised Clinical Trial Approaches

The Trials@Home consortium explored the opportunities of moving clinical trials from the traditional clinic setting to the participant’s immediate surroundings. These Decentralised Clinical Trials (DCTs) make use of digital and operational innovations, enabling participants to visit a clinical trial centre less frequently, if at all. The research conducted by Trials@Home includes an inventory and evaluation of existing and new techniques for use in DCTs as well as a pan-European proof-of-concept study.

Key objectives

Defined the best practices for the conduct of DCTs.
Identified technologies and other operational innovative approaches for DCTs and selected the appropriate technology package to be used for RADIAL, the proof-of-concept study.
Designed and ran a proof-of-concept study, comparing the scientific and operational quality of the DCT with conventional trial approaches and evaluating the acceptability and feasibility of the hybrid and fully DCT approaches.
Identified, mapped and analysed the relevant ethical, quality, regulatory, legal and organisational barriers and enablers of DCTs.
Consulted with stakeholders and promoted the outcomes from the Trials@Home consortium through targeted communication, dissemination and training activities.
Provided recommendations with supporting tools for implementing DCTs in Europe and contributed to the update of ICH guidelines on DCTs.

Co-creative, multi-stakeholder approach

Trials@Home was funded by the EU/EFPIA Innovative Medicines Initiative [2] Joint Undertaking (grant n° 831458) and followed a co-creative, multi-stakeholder approach where academic partners, small and medium-sized enterprises (SMEs), private foundations, patient organisations and EFPIA partners worked together with other stakeholders from across the medical, technological, regulatory, ethical and social fields of DCTs.

To this end, the consortium formed two external advisory bodies: the External Stakeholder Panel (ESP) led by World Duchenne Organisation and the Patient Expert Panel (PEP) led by International Diabetes Federation Europe. This allowed the project to incorporate the views and knowledge of the various stakeholders to ensure relevance and feasibility of project deliverables.