What Are Decentralized Clinical Trials? (And How Wearables Facilitate Them)

A decentralized clinical trial (DCT) is a clinical trial in which some or all study activities happen away from a traditional research site: in participants' homes, through telehealth, with local health care providers, or at local labs. Instead of traveling for every visit, participants can give consent online, wear a device, complete surveys on their phone, and collect samples at home.

A study can be fully remote, or it can keep one or two in-person steps and run everything else remotely; both count as decentralized trials. This guide covers which parts of a trial can be remote, the benefits and limitations, what FDA guidance says, and when a supplement or ingredient brand might choose this model. For a side-by-side comparison with site-based studies, see centralized vs decentralized clinical trials.

What Are Decentralized Clinical Trials?

DCTs represent a significant shift in the way clinical trials are conducted. They leverage technology and remote tools to enhance participant convenience, accessibility, and data collection efficiency. The term "decentralized" implies moving trial activities away from traditional, centralized study sites and into participants' homes or local health facilities.

FDA's guidance defines a decentralized clinical trial as one that includes decentralized elements, where trial-related activities occur at locations other than traditional clinical trial sites. Those elements can include telehealth visits with study staff, in-home visits by study staff, and visits with local health care providers.

DCTs often incorporate digital health technologies (DHTs), such as wearable devices, mobile applications, and telemedicine platforms, to enable remote communication, monitoring, and data collection.

Through decentralization, DCTs can reduce the burden on participants, support recruitment and retention, and capture real-world data.

Which Parts of a Clinical Trial Can Be Remote?

Most steps that do not need hands-on care or specialized equipment can move closer to participants. Common decentralized elements include:

Recruitment and screening can move online too. Many studies combine several of these elements, and FDA's guidance says the protocol should specify which visits happen at a site, which happen remotely, and which are left to the participant's choice.

Benefits of Decentralized Clinical Trials

The main benefits of decentralized clinical trials are wider access, less burden on participants, more frequent data from daily life, and support for recruitment and retention. For supplement and wellness products there is one more: the study can measure the product where it is actually used.

These benefits depend on design. Clear instructions, responsive participant support, and a plan for missing data decide how much the remote data can support.

Limitations of Decentralized Clinical Trials

Decentralized trials are not the right fit for every study, and a sound plan accounts for their tradeoffs from the start. The main limitations are:

Our comparison of centralized and decentralized models explains when a site-based study is the better choice.

How Do Wearables Facilitate DCTs?

Wearable devices enable remote data collection and real-time participant monitoring. These technologies allow researchers to gather valuable data without in-person visits, capturing physiological and behavioral data like sleep patterns and blood sugar levels.

Wearable data still needs planning. Before enrollment, the protocol should name the device metrics that serve as endpoints, set a minimum wear time, and explain how missing days will be treated in the analysis. FDA's December 2023 guidance, Digital Health Technologies for Remote Data Acquisition in Clinical Investigations, covers selecting devices, using their data for trial endpoints, and training participants. As wearable technology improves, more outcomes can be measured this way. For device choices and data types, see our guide to wearables in decentralized clinical trials.

FDA Guidance on Decentralized Clinical Trials

DCTs are gaining significant momentum, having accelerated in recent years following the COVID-19 pandemic. In September 2024, FDA issued final guidance, Conducting Clinical Trials With Decentralized Elements, for sponsors, investigators, and others running trials with remote components. Its main points include:

• FDA's requirements for investigations of medical products are the same whether or not a trial includes decentralized elements.
• The protocol should specify which visits happen at a site and which happen remotely, and how adverse events identified remotely will be evaluated and managed.
• Informed consent can be obtained remotely, electronically or on paper, when all applicable requirements are met, with IRB oversight of the process. When appropriate, FDA recommends a central IRB.
• The safety monitoring plan should take the decentralized design into account.
• Sponsors should keep a record of contracted service providers, such as local health care provider networks, and their roles.
• When study products are shipped directly to participants, the investigator remains responsible for supervising that supply.

The guidance is written for trials run under an IND or IDE, but FDA recommends that sponsors of trials that do not need one take its considerations into account. Many supplement and wellness studies do not run under an IND or IDE. Either way, remote steps follow the same Good Clinical Practice principles as site visits.

When Should a Supplement or Ingredient Brand Choose a Decentralized Trial?

A decentralized design is often a practical fit for supplement, ingredient, and wellness device studies when:

• The product is used at home and can be shipped safely to participants.
• The primary outcome can be measured reliably outside a clinic, such as sleep, heart rate variability, activity, or participant-reported symptoms.
• The product has a well-characterized safety profile and does not need supervised preparation or administration.
• Your target customers are comfortable with phones, apps, and wearables, or the study can provide devices.
• You want a larger or more geographically varied group than a single site could enroll.

Plan at least one in-person or local lab step if the study needs imaging, supervised testing, or close observation. Also decide early how the results will be used, because a pilot for an internal decision and a study behind a published claim call for different designs.

How Reputable Runs Decentralized Studies

Reputable Health uses wearables to run decentralized clinical studies for wellness products, from 4-week pilots to 1 to 6 month studies.

Screening starts from an existing community of health-engaged people who chose to take part in research, and participants bring wearable history that can inform screening and baseline planning. Daily check-ins, automated reminders, and the Heartbeats rewards program keep adherence visible for the whole study. Studies can combine continuous wearables including Oura, Apple Watch, and Whoop, at-home labs with blood biomarkers processed through CLIA-certified labs, and established surveys such as PROMIS and PSQI, joined per participant into a single dataset. IRB oversight is built in, and ClinicalTrials.gov registration is available.

Brands can start with a pilot study that tests for signal on a smaller scope, move on to full clinical studies with custom protocols, IRB approval, and pre-registered statistical methodology, or run both. See how a Reputable study comes together.

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