Related Experiment Video
Updated: Jan 16, 2026

Real-Time Proxy-Control of Re-Parameterized Peripheral Signals using a Close-Loop Interface
Published on: May 8, 2021
Regulatory Interactions and Learnings-RADIAL the Trials@Home Proof-of-Concept Trial on Decentralization
Helga Gardarsdottir1,2,3, Hamidou Traore4, Kate Huntley5
1Division Pharmacoepidemiology and Clinical Pharmacology, Utrecht Institute for Pharmaceutical Sciences, Faculty of Science, Utrecht University, Utrecht, The Netherlands.
Early regulatory engagement is crucial for successful decentralized clinical trials. Sharing experiences can overcome legislative hurdles and advance European clinical research.
Area of Science:
- Clinical Trials Methodology
- Regulatory Science
- Health Services Research
Background:
- The RADIAL trial is a proof-of-concept study evaluating decentralized clinical trial elements.
- It is the first to assess feasibility and acceptability across six European countries using fully decentralized, hybrid, and conventional arms.
Purpose of the Study:
- To present insights from regulatory interactions during the setup and submission of the RADIAL trial.
- To highlight challenges and best practices for decentralized clinical trials (DCTs) in a multi-jurisdictional European context.
Main Methods:
- Analysis of formal regulatory interactions including European Medicines Agency (EMA) consultation and national Scientific Advice.
- Review of the clinical trial application submission under the EU Clinical Trials Regulation (536/2014).
Main Results:
- Constructive feedback from regulatory bodies aided protocol finalization and trial conduct.
- The study identified complexities arising from varying national legal and regulatory requirements across Europe.
Conclusions:
- Early and continuous engagement with regulatory authorities is essential for innovative trial designs like DCTs.
- Harmonized guidance and transparency in sharing regulatory experiences are needed to facilitate wider DCT adoption in Europe.
More Related Videos
06:04Experimental Investigation of the Hierarchical Control in DC Microgrids Using a Real-time Simulator
Published on: February 14, 2025
06:32Author Spotlight: Automated Deep Brain Stimulation for Parkinson's Disease - Exploring the Possibilities and Challenges of Home Monitoring
Published on: July 14, 2023
Related Concept Videos
Global Regulatory Systems
Radial System Protection
In a radial system with a fault downstream of the third breaker, ideally, only the third breaker will open, isolating the fault and interrupting the load connected beyond it. The second breaker has a longer delay setting,...
Neural Regulation
Self-Regulation
Drug Control Governance: Regulatory Bodies and Their Impact
Randomized Experiments
Simple randomization
Simple...