Trials@Home recommendations on the conduct of decentralised clinical trials

The Trials@Home website provides a structured set of recommendations on decentralised clinical trial (DCT) approaches, developed from six years of work by an international public–private consortium. It explores how trial activities can be shifted from investigational sites to participants’ homes or local environments, using digital tools and new operational models, and tests these concepts in the RADIAL proof‑of‑concept trial.

The main recommendations page offers high‑level guidance and links to in‑depth thematic sections that give practical advice on:

• deciding which trial activities to decentralise, involving patient representatives and research staff while keeping the research question and participant burden central
• setting clear expectations for participants, including procedures that support engagement and fair compensation
• ensuring ethical and regulatory acceptability of decentralised elements
• assessing site capabilities and providing appropriate training, support and compensation
• selecting and testing technologies, with strong governance, data protection and secure digital infrastructures
• planning decentralised logistics, including shipment of investigational medicinal products and study materials
• defining roles, responsibilities and oversight mechanisms for all parties involved in DCTs

These recommendations are organised into six thematic areas (Activities and Operations, Impact and Key Performance Indicators, Patient Considerations and Involvement, Assessment and Approval, Oversight and Clinical Management, and Technology and Support), giving more detailed guidance on participant accessibility, representativeness, retention, site processes and monitoring.

In addition, Trials@Home provides an online decentralised clinical trial course that introduces core concepts, presents the RADIAL trial and offers practical lessons on technology use, participant burden and organisational change, supporting training for investigators and study teams. For investigator‑initiated or academically sponsored studies, the resource offers concise conceptual and operational guidance for designing and running decentralised or hybrid trials, including participant involvement, consent and communication, site readiness, monitoring, risk management and technology selection.