Decentralized Clinical Trials and Digital Health Technologies: How Remote Research Works
By Heather Reichert • Updated Nov 9, 2026 • Reviewed by editorial
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Decentralized clinical trials (DCTs) and digital health technologies (DHTs) are changing how new medicines and treatments are studied. Instead of requiring every participant to travel to a hospital or research center, many parts of a trial can now happen at home or at a nearby clinic. The U.S. Food and Drug Administration describes DCTs as studies in which some or all trial activities occur outside a traditional clinical trial site.
These approaches can make clinical trials more accessible, convenient, and representative of real-world patients.
What Is a Decentralized Clinical Trial?
A decentralized clinical trial is a clinical study in which some or all trial activities happen outside a traditional research site. Participants may complete visits, report symptoms, receive medication, or be monitored from home or a local health facility.
There are two main types:
Fully decentralized trials: All trial activities take place outside a traditional clinical trial site.
Hybrid trials: Some activities happen in person at a research site, while others are completed remotely.
Decentralized trials can help include people in rural areas, people with limited mobility, and those who live far from major research centers. They may also improve participation, reduce missing data, and support more diverse study populations.
What Are Digital Health Technologies?
Digital health technologies are digital tools used to collect or support health information. In clinical trials, they can include smartphone apps, wearable devices, remote sensors, electronic diaries, telehealth visits, and online consent forms.
These tools may be worn, implanted, ingested, or placed in a participant’s home. They allow researchers to collect health data in real time, rather than relying only on occasional in-person visits.
Examples include:
Smartwatches that track heart rate, activity, or sleep
Home blood-pressure monitors, glucose meters, and breathing devices
Mobile apps that record symptoms, medication use, or side effects
Video visits with doctors or study staff
Electronic informed-consent forms and patient education material
How COVID-19 Changed Clinical Research
Before the COVID-19 pandemic, decentralized trials were mostly used in smaller studies or for secondary measurements. Few trials were fully decentralized.
During the pandemic, travel restrictions, social distancing, and hospital capacity limits made traditional clinical trials difficult to run. Remote visits, electronic consent, home monitoring, and mobile health teams helped researchers continue ongoing studies and begin new ones, including COVID-19 vaccine trials.
The pandemic did not create these tools, but it accelerated their use. It showed that many parts of a clinical trial can be done remotely when proper safeguards are in place.
How Decentralized Trials Help Patients
Traditional clinical trials often require repeated trips to a research center. That can be difficult for people with jobs, caregiving responsibilities, chronic illness, transportation barriers, or limited access to major medical centers.
Decentralized approaches can reduce that burden by allowing participants to complete screening and consent online, attend video visits, report symptoms through an app, use approved health devices at home, receive study medication directly, or visit a nearby clinic when needed.
This flexibility can make participation easier and may help researchers collect more complete information about how a treatment works in everyday life.
Benefits for Clinical Research
DCTs and DHTs offer several potential benefits for patients, researchers, and study sponsors.
| Area | Potential benefit |
|---|---|
| Access | More people can participate, including those in rural or underserved communities. |
| Diversity | Trials can reach broader populations across different locations. |
| Retention | Flexible participation may reduce dropout and missing data. |
| Data quality | Continuous monitoring can capture real-world symptoms and health changes. |
| Speed | Remote enrollment and digital consent may help trials move faster. |
| Cost | Fewer unnecessary site visits may reduce some operational costs. |
Challenges of Remote Clinical Trials
Decentralized trials are not automatically better than traditional trials. They must be designed carefully to protect participants and produce reliable results.
Some procedures still require in-person care, such as imaging scans, physical examinations, complex treatments, or specialized medical testing. Remote measurements also need to be accurate, secure, and meaningful for the condition being studied.
Other challenges include protecting patient privacy, making devices easy to use, supporting people with limited digital skills, safely delivering medication, and addressing regulatory and reimbursement requirements.
A hybrid approach is often best: use remote tools where they help, while keeping in-person visits when they are medically necessary.
What This Means for Patients
For patients, decentralized trials can mean fewer trips, more flexibility, and the ability to participate in research from home. For researchers, these tools offer a way to gather richer real-world data while reaching people who might otherwise be excluded from clinical research.
Technology should support patients, not overwhelm them. A well-designed trial should provide clear instructions, accessible consent materials, reliable technical support, and in-person options when needed.
Questions to Ask Before Joining
If you are considering a clinical trial, ask the research team:
Which visits can be done remotely, and which require an in-person appointment?
What device, app, or equipment will I need to use?
Who can help me if I have technical problems?
How will my health information be protected?
Will I receive updates or health-related information during the study?
Are there options if I do not have a smartphone, reliable internet, or transportation?
What happens if I experience side effects or need urgent care?
Learn More
You can learn more about how clinical trials work from the FDA’s patient guide to clinical trials, search for studies on ClinicalTrials.gov, or review the NIH’s information on clinical research trials.
For information about participant rights and research protections, visit the U.S. Department of Health and Human Services Office for Human Research Protections. You can also learn about digital health technology policy from the FDA Digital Health Center of Excellence and find patient-focused research information through the National Library of Medicine.
Decentralized clinical trials and digital health tools are not a replacement for careful medical research. When used thoughtfully, they can make clinical trials more patient-centered, inclusive, and connected to real life.
