Bringing Trial Activities to Participants-The Trials@Home RADIAL Proof-of-Concept Trial Investigating Decentralization of Trials.

ABSTRACT: The interest in trials in which activities are being moved to the participants' direct environment, that is, decentralized, has increased in recent years, but limited research has been conducted into the feasibility and acceptability of such approaches. The Trials@Home RADIAL proof-of-concept (PoC) trial aims to assess the scientific and operational feasibility and quality of a fully decentralized and hybrid trial approach compared to a conventional, site-based approach. RADIAL is a three-arm parallel-group, open-label, multi-center low-intervention phase IV trial conducted in people living with Type 2 diabetes mellitus in six European countries (DE, DK, ES, IT, PL, UK). The RADIAL trial compares three arms with the same clinical intervention (Insulin Glargine 300 U/mL) but differing degre

SUBMITTER: Zuidgeest MGP 

PROVIDER: S-EPMC12598128 | biostudies-literature | 2025 Nov

REPOSITORIES: biostudies-literature