Regulatory Interactions and Learnings-RADIAL the Trials@Home Proof-of-Concept Trial on Decentralization.

ABSTRACT: This paper is part of a series of six publications presenting lessons learned during the setup, regulatory submission, and conduct of the proof-of-concept Trials@Home RADIAL trial. The three-arm RADIAL trial, comprising fully decentralized, hybrid, and conventional arms, is the first clinical study to evaluate the feasibility and acceptability of decentralized clinical trial elements across six European countries. In this paper, insights from multiple formal regulatory interactions related to the RADIAL trial, conducted between 2021 and 2022, are presented. These interactions included (i) a consultation with the European Medicines Agency's Innovation Task Force, (ii) a national Scientific Advice procedure, and (iii) the clinical trial application submission under the EU Clinical Trials Reg

SUBMITTER: Gardarsdottir H 

PROVIDER: S-EPMC12598124 | biostudies-literature | 2025 Nov

REPOSITORIES: biostudies-literature