Decentralized Clinical Trials: At-Home Studies and Remote Participation

Decentralized clinical trials (DCTs) move some or all study activities from traditional research sites into participants’ homes and local healthcare settings. The model expanded dramatically during COVID-19, when in-person visits were limited, and has continued to grow. For participants, decentralized trials can reduce travel burden, expand geographic access to research, and often improve completion rates. For sponsors, they enable larger and more diverse enrollment. This guide covers decentralized clinical trials – how they work, what technology is involved, the advantages and limitations, the current FDA framework, and which trial types are best suited for remote participation.

What makes a trial “decentralized”

Decentralized trials shift activities that traditionally happen at a clinical research site to other locations. The shift can be partial (hybrid) or complete (fully decentralized). Common decentralized elements include:

• Video (telehealth) visits with study clinicians instead of in-person visits
• At-home blood draws or sample collection
• Remote monitoring through wearable devices
• Direct-to-participant drug shipment
• Local lab work at facilities such as LabCorp or Quest near the participant’s home
• Electronic informed consent (eConsent) reviewed and signed at home
• Home-health visits by traveling nurses
• Smartphone-based symptom tracking and questionnaires

The level of decentralization varies. A fully decentralized trial may not require any visits to a traditional research site; a hybrid trial may keep screening and key assessments at a site while handling most ongoing care remotely. The right mix depends on what the study needs to measure safely and accurately.

Why decentralized trials matter

Traditional site-based trials have real limitations:

• Geographic limitations: Participants must live within driving distance of a research site, which concentrates enrollment near major academic centers.
• Time commitment: In-person visits require travel, parking, and time away from work – often the biggest barrier for working participants and caregivers.
• Demographic skewing: Site-based populations can over-represent people near academic centers and under-represent rural, working-class, and minority communities.
• Drop-out rates: Travel burden contributes to participants discontinuing before completion.

Decentralized models can address these limitations by reducing travel and expanding reach, so people can consider trials regardless of distance from a research site. That has the potential to improve diversity and access – a goal both the FDA and NIH have emphasized – though, as noted below, decentralization does not automatically solve equity gaps.

How decentralized trial visits work

A typical decentralized trial visit might include:

1. A video call with the study clinician at a scheduled time
2. Symptom and medication review through structured questions
3. Vital signs collected through a connected device or by a visiting nurse
4. Lab work done at a local lab (LabCorp, Quest, or partner labs)
5. Imaging at local facilities if needed (less common for decentralized trials)
6. Adverse event review and safety assessments
7. Scheduling of the next visit

The video portion of a visit is commonly 30-60 minutes, plus separate time for any in-person elements such as a lab draw or home nurse visit. For many participants, total time is less than a traditional site visit once travel is included – but the exact burden depends on the specific protocol.

Technology used in decentralized trials

Decentralized trials rely on several technology categories:

Telehealth platforms: Video-visit tools designed for clinical research, with documentation, recording, and integration into the trial’s electronic data capture system.

Wearable devices: Continuous monitoring of activity, heart rate, sleep, and other parameters. Consumer devices (such as an Apple Watch or Fitbit) and research-specific wearables collect data passively.

Connected medical devices: Blood pressure cuffs, glucometers, ECG monitors, pulse oximeters, and scales that transmit readings to the study database.

Smartphone apps: Symptom tracking, medication-adherence reminders, electronic patient-reported outcomes (ePROs), and secure communication with the study team.

eConsent platforms: Electronic consent forms with multimedia explanations, comprehension checks, and digital signature capture.

Drug shipping logistics: Cold-chain delivery for temperature-sensitive investigational products; standard shipping for stable medications – with chain-of-custody safeguards for accountability.

Which trials are best suited for decentralization

Decentralization tends to work best for:

• Trials of stable chronic conditions (hypertension, type 2 diabetes, depression) that can be monitored remotely
• Trials of medications that do not require complex monitoring or procedures
• Longer observational studies focused on patient-reported outcomes
• Trials with broad eligibility that do not require specialized facility procedures
• Later-phase trials of medications already in clinical use
• Long-term follow-up phases of studies that began with traditional site visits

Decentralization works less well for:

• Phase 1 trials requiring intensive safety monitoring and rapid intervention capability
• Trials of complex procedures or surgeries
• Trials requiring specialized imaging or laboratory equipment
• Trials in pediatric or other populations needing extensive in-person supervision
• Studies with high rates of acute, serious adverse events

Advantages for participants

The participant advantages can be substantial:

• Reduced travel burden: No driving to research sites, no parking fees, no traffic.
• Geographic flexibility: You may be able to participate from home regardless of location.
• Time savings: Many decentralized visits are shorter than traditional site visits once travel is counted.
• Family flexibility: Childcare and caregiving obligations can be easier to manage with home-based visits.
• Privacy: No need to be seen at a research site by acquaintances.
• More frequent monitoring: Continuous remote monitoring through wearables can, in some studies, surface issues between scheduled visits.

For many participants, these advantages meaningfully outweigh the trade-offs of remote participation – though the balance is individual.

Limitations, safety, and data considerations

Decentralized trials also carry real limitations that sponsors and participants should weigh:

• Technology requirements: Participants generally need reliable internet and the ability to use trial-provided devices.
• Self-administration and measurement: Some assessments depend on participant accuracy in self-measurement, which can add variability.
• Limited physical exam: Video visits cannot fully replace an in-person examination for certain assessments.
• Adverse event response: Rapid in-person intervention for serious adverse events requires nearby clinical infrastructure and a clear safety plan.
• Data quality and privacy: Remote data from consumer devices must be validated, and personal health data collected across apps and devices raises privacy and security considerations that protocols must address.
• Equity concerns: Decentralization can paradoxically exclude people without reliable internet or comfort with technology, working against the diversity goal it aims to serve.

Sponsors increasingly address these issues through device-and-connectivity-included models (providing tablets and internet) and hybrid designs that combine remote and in-person elements where safety or data quality requires them.

Regulatory framework and FDA guidance

The FDA supports the use of decentralized elements in trials. After issuing a draft in 2023, the agency finalized its guidance, “Conducting Clinical Trials With Decentralized Elements,” in September 2024. The final guidance – issued jointly by FDA’s drug, biologics, and device centers and the Oncology Center of Excellence – provides recommendations for incorporating remote and distributed activities (such as telehealth visits, in-home visits by trial personnel, and visits with local healthcare providers) while maintaining the same scientific rigor and participant protections required for traditional trials.

Two protections carry over fully to DCTs: informed consent (participants must understand the study’s purpose, procedures, risks, and their right to withdraw) and Institutional Review Board (IRB) oversight, which reviews and monitors the study to protect participants. eConsent is permitted but must still meet these standards.

State-level licensing remains a practical complication: clinicians providing care by video generally must be licensed in the state where the participant is physically located. Trials that enroll across many states may need clinicians licensed in each, which can complicate broad geographic enrollment.

Examples of decentralized trial types

Diabetes management trials: Continuous glucose monitor data, A1c at local labs, video visits with endocrinologists, smartphone-based dietary tracking.

Hypertension trials: Connected blood pressure monitors with automated transmission, video visits, medication shipping.

Depression and anxiety trials: ePRO assessments via smartphone, video psychiatric visits, medication shipping.

Long COVID trials: Symptom diaries via app, wearable monitoring of cardiac and exercise capacity, occasional local lab work.

For specific conditions, our guides to clinical trials for type 2 diabetes, clinical trials for depression, and clinical trials for long COVID cover what decentralized options exist.

How to find a decentralized trial

The primary public resource is ClinicalTrials.gov, the NIH-maintained registry of studies conducted around the world. You can search by condition, location, and status, and each listing describes eligibility criteria, what participation involves, and how to contact the study team. Because “decentralized” is not always a formal filter, read the study description for remote or home-based elements, and ask the study coordinator directly which visits are remote versus in person. Before enrolling, discuss any trial with your own clinician, and make sure you understand the consent form, the time commitment, potential risks, and what happens if you want to stop.

Frequently Asked Questions

Are decentralized trials as rigorous as traditional trials?

When properly designed, yes. The FDA holds trials with decentralized elements to the same scientific and regulatory standards as traditional trials, and data quality from well-designed DCTs can be comparable. The final 2024 FDA guidance reinforces those expectations.

Do I need special equipment to participate?

Often the trial provides necessary devices (such as blood pressure monitors, wearables, or tablets). Participants typically need a smartphone and reliable internet; some studies supply connectivity if you lack it. Ask the study team what is provided.

Can my doctor be involved in a decentralized trial?

Yes. Many decentralized trials coordinate with your existing physicians for medical history, ongoing care, and adverse-event response. Some require physician involvement; others operate more independently. It is reasonable to keep your own clinician informed.

What if I have a serious adverse event?

Decentralized trials must maintain protocols for serious adverse events, including emergency response, in-person evaluation when needed, and coordination with local emergency services or hospitals. Ask for the study’s safety plan before you enroll.

Are payments for decentralized trials similar to traditional trials?

Generally, participant compensation is comparable. The lower travel burden may change how costs are structured, but IRB-approved compensation for time and effort is similar in principle. Confirm details with the specific study.

The bottom line on decentralized clinical trials

Decentralized clinical trials have reshaped research access and participation. The model can reduce travel burden, expand geographic reach, and improve enrollment diversity while maintaining scientific rigor and participant protections. For participants, the potential advantages are real – less time commitment, more flexibility, and the ability to consider studies regardless of distance from a research site – though technology access, self-measurement, and safety planning matter. For trial types well suited to decentralization (chronic conditions, stable medications, observational studies), remote and hybrid designs are increasingly common; for Phase 1 trials and complex interventions, traditional site-based research remains appropriate. With the FDA’s final 2024 guidance in place, the hybrid model that blends remote and in-person elements is now a mainstream approach across many trial types.

Sources

• U.S. Food and Drug Administration – “Conducting Clinical Trials With Decentralized Elements,” final guidance issued September 2024 (preceded by a 2023 draft) (fda.gov)
• NIH / ClinicalTrials.gov – registry for finding clinical trials and understanding participation (clinicaltrials.gov)
• National Institutes of Health – informed consent and Institutional Review Board (IRB) oversight resources (nih.gov)