Trials@Home is a collaborative initiative that brings together academic partners, SMEs, private foundations, patient organisations, and EFPIA partners, along with stakeholders from various fields such as medical, technological, regulatory, ethical, and social domains. The project aims to develop practical recommendations to support the widespread acceptance and use of decentralised clinical trial (DCT) approaches in Europe.
In its fifth year, RADIAL, the proof-of-concept study, achieved a significant milestone by recruiting its first participant on August 22, 2023, marking the transition from preparation to execution. To enhance recruitment efficiency, a substantial protocol amendment was submitted and approved in all participating countries, adjusting the inclusion and exclusion criteria. Recruitment continued until May 14, 2024, enrolling 100 participants in Part A and 8 in Part B.
The technology package for RADIAL was meticulously assembled, tested, and implemented. This included a comprehensive helpdesk system featuring a knowledge base and a ticketing system to streamline support requests and issue resolution. Ongoing manual data cleaning and automated query closure were performed to maintain data quality. The Data Management Plan (DMP) for RADIAL was developed and integrated into the overall project DMP. Detailed processes for the delivery of study medications and materials were established, ensuring smooth logistics. Extensive training materials for site staff and patients were developed and implemented, supported by the communication team and the Patient Expert Panel.
Research activities on best practices for DCTs continued with analysing the qualitative data collected from interviews on existing case studies related to DCTs. In addition, a database analysis was performed on the role of the physical examination in clinical trials and stakeholder interviews on this topic are planned. To analyse patient preferences, a discrete choice experiment has been set up, after an initial assessment on drivers and perceptions regarding participation in DCTs, for which a paper has been submitted to a peer-reviewed journal. Finally, several new publications on the ethical, regulatory, and operational challenges of DCTs have been published.
The consortium actively engaged with stakeholders through conferences, workshops, and webinars, disseminating findings and learnings from the Trials@Home project. The External Stakeholder Platform (ESP) and Patient Expert Panel (PEP) provided valuable input, ensuring the patient voice was reflected in the research process. A new team has been put together to start working on layman translations of papers and other documents produced by the consortium. The glossary team has also completed the final glossary update and collaborates on the alignment with other DCT-related glossary owners to ensure DCT terminologies are consistent across the European and American forums. The Sustainability Working Group focused on developing plans for the long-term sustainability of the project’s outputs, including collaboration with other initiatives and the development of course materials. A working group was also formed to focus on communicating about RADIAL outputs and learnings, starting with a newsletter distributed to sites.
Communication and dissemination activities were robust, with regular updates on the project website, social media, and newsletters. The project engaged with stakeholders through various events and developed training materials and awareness campaigns about DCTs. Overall, these activities generated valuable DCT knowledge, leading to the publication of scientific articles and public deliverables, all available via trialsathome.com.
