Related Experiment Video
Updated: Sep 9, 2025
06:32
Author Spotlight: Automated Deep Brain Stimulation for Parkinson's Disease - Exploring the Possibilities and Challenges of Home Monitoring
Published on: July 14, 2023
1.4K
Bringing Trial Activities to Participants-The Trials@Home RADIAL Proof-of-Concept Trial Investigating
Mira G P Zuidgeest1, Megan Heath2, Bart Lagerwaard1
1Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht, The Netherlands.
Clinical Pharmacology and Therapeutics
|September 1, 2025
Summary
Decentralized clinical trials are being explored for feasibility. The RADIAL trial assesses fully decentralized and hybrid approaches versus site-based methods in Type 2 diabetes patients, evaluating key performance indicators for future implementation.
Area of Science:
- Clinical Trials Methodology
- Decentralized Clinical Trials
- Digital Health
Background:
- Interest in decentralized clinical trials (DCTs) is growing, but research on their feasibility and acceptability is limited.
- The Trials@Home RADIAL proof-of-concept (PoC) trial addresses this gap by evaluating decentralized approaches.
- Type 2 diabetes mellitus is a focus area for exploring novel trial designs.
Purpose of the Study:
- To assess the scientific and operational feasibility and quality of fully decentralized and hybrid clinical trial approaches.
- To compare decentralized trial models against a conventional, site-based approach.
- To provide insights for future PoC trials and support stakeholders in implementing decentralized elements.
Main Methods:
- A three-arm, parallel-group, open-label, multi-center, low-intervention Phase IV trial design.
- Comparison of three arms with identical clinical intervention (Insulin Glargine 300 U/mL) but varying decentralization levels.
- Inclusion of decentralized elements: online recruitment, remote consenting, remote visits, home-shipment of study materials, home-based sample collection, app-reported outcomes (ePROs), and home-device data collection.
Main Results:
- Key Performance Indicators (KPIs) for recruitment, retention, diversity, satisfaction (site and participant), cost, safety, adherence, and data quality are the primary outcomes.
- This paper focuses on the set-up, design, endpoint selection, and decentralized elements evaluated in the RADIAL trial.
- Lessons learned from the set-up, regulatory submission, and conduct of RADIAL will be shared across a series of publications.
Conclusions:
- The RADIAL trial provides a framework for evaluating the feasibility and quality of decentralized and hybrid clinical trial models.
- Insights gained will support the successful implementation of decentralized elements in future clinical trials.
- This study contributes to advancing the methodology of decentralized clinical trials for conditions like Type 2 diabetes.
More Related Videos
Related Concept Videos
01:16Clinical Trials
7.8K
Clinical trials are prospective experimental studies conducted on humans to determine the safety and efficacy of treatments, drugs, diet methods, and medical devices. Using statistics in clinical trials enables researchers to derive reasonable and accurate conclusions from the collected data, allowing them to make wise decisions in uncertain situations. In medical research, statistical methods are crucial for preventing errors and bias.
There are four phases in a clinical trial. A phase one...
There are four phases in a clinical trial. A phase one...
7.8K
01:11Clinical Trials: Overview
3.4K
Clinical development focuses on how the drug will interact with the human body and encompasses four key phases of clinical trials, each serving a specific purpose in assessing the safety and effectiveness of new drugs. These phases overlap and build upon one another. Phase I involves a small group of healthy volunteers (typically 20-80 individuals) or, in cases where significant toxicity is expected, patients with the targeted disease, such as cancer or AIDS. The volunteers are tested for...
3.4K
01:11Blinding
2.6K
Blinding is a commonly used method of not telling participants which treatment a subject is receiving. Blinding is a critical part of a randomized control trial or RCT. It reduces the bias that affects the results. In an RCT, blinding is used in the form of a placebo. A placebo effect occurs when untreated subjects falsely believe they have received the treatment and report improved symptoms. A placebo or a dummy treatment is administered to subjects to negate the bias caused by such an effect.
2.6K
01:13Randomized Experiments
7.2K
The randomization process involves assigning study participants randomly to experimental or control groups based on their probability of being equally assigned. Randomization is meant to eliminate selection bias and balance known and unknown confounding factors so that the control group is similar to the treatment group as much as possible. A computer program and a random number generator can be used to assign participants to groups in a way that minimizes bias.
Simple randomization
Simple...
Simple randomization
Simple...
7.2K
01:29Issues And Trends In Healthcare Delivery System
5.8K
The issues and trends in healthcare delivery are constantly changing. The COVID-19 pandemic is one recent issue that wreaked havoc on healthcare systems, causing a shortage of healthcare workers, high demand for medicines and supplies, and increased medical expenditure due to a lack of insurance. Other issues include rising healthcare costs and care fragmentation.
Cost Containment
Payment for healthcare services has historically promoted adoption of costly and often unnecessary or inefficient...
Cost Containment
Payment for healthcare services has historically promoted adoption of costly and often unnecessary or inefficient...
5.8K
01:12Trial and Error and Algorithm
191
A problem-solving strategy is a plan of action used to find a solution. Different strategies have distinct action plans. Trial and error involves trying different solutions until one works. For instance, to fix a broken printer, you might check ink levels, ensure the paper tray isn't jammed, and verify the printer's connection to your laptop. This method can be time-consuming but is commonly used. Thomas Edison, for example, used trial and error to find a suitable filament for the light...
191