How FDA’s Guidance on Decentralized Trials Applies to Community-based Research Execution and Compliance

In September 2024, the U.S. Food and Drug Administration (FDA) issued its final guidance titled Conducting Clinical Trials with Decentralized Elements. The document outlines how decentralized trial components—particularly mobile visits conducted in participants’ homes, mobile research sites, and local community health facilities—can be implemented in a compliant, regulated framework.

The guidance reflects the FDA’s growing recognition that mobile and community-based trial activities are critical for expanding access, improving diversity, reducing participant burden, and increasing retention. It also reinforces that decentralization does not diminish regulatory expectations. Whether a visit happens in a local community health center, a mobile research site, or a patient’s living room, it must meet the same thresholds for oversight, data reliability, and participant safety—affirming that decentralized trials must reach participants across the entire care continuum, from the “last mile” via mobile and community-based sites to the “last millimeter” via in-home care.

This is the first of two articles looking more closely at what community-based research is and how it’s delivered; here, we distill regulatory guidance into actionable insights, with examples illustrating how mobile and community-centered models can align with FDA expectations.

How the FDA Defines Decentralized Clinical Trials — and the Role of Community-based Research

According to the FDA, a decentralized clinical trial (DCT) is one in which trial-related activities occur away from traditional brick-and-mortar research sites. These include:

• In-home visits by mobile trial staff
• Visits at mobile research sites
• Visits at local community health centers
• Remote interactions via telehealth

The guidance clearly identifies mobile visits and community-based sites as legitimate and essential components of a DCT. The FDA explicitly states:

In-person visits and trial-related activities can be conducted by trial personnel who are sent to participants’ homes or participants’ preferred locations.

The FDA’s guidance marks a significant shift in how clinical trials can be delivered. By stating “preferred locations,” the FDA validates using mobile sites and clinical staff to perform key trial procedures, such as physical exams, blood draws, or safety checks, and IP administration outside of traditional research sites. Whether the visit happens in a participant’s home or another convenient setting, the FDA confirms that this decentralized approach is fully compliant, as long as it’s executed by qualified personnel and aligned with the protocol.

This model improves access without compromising data quality or participant safety for patients facing geographic, logistical, or mobility-related challenges. It’s a strong signal that the agency supports bringing trials to the patient, provided the operational and oversight standards are equally robust.

Decentralization Now Has Full Regulatory Backing

The FDA clarifies that decentralized elements do not lower the bar for compliance. Sponsors and investigators must meet all regulatory obligations, regardless of location.

FDA’s regulatory requirements for investigations of medical products are the same for trials that include decentralized elements and trials that do not.

The FDA expects every decentralized trial—whether it includes home visits, mobile units, or community-based care—to meet the exact same requirements for patient safety, data integrity, documentation, and oversight as a traditional site-based trial. Whether an infusion is administered in a research center, a mobile clinic, or a living room, it needs the same training protocols, monitoring plans, and recordkeeping. The location may change, but the responsibility does not.

Community Health Center Sites Are Fully Within Scope

While much attention has been placed on home visits, the guidance supports a broader view of decentralized care. The FDA emphasizes the role of local healthcare providers (HCPs) and alternative locations in facilitating trial-related activities.

Depending on the trial protocol, in-person visits and trial-related activities may also be conducted by HCPs who are located close to trial participants’ homes.

The FDA’s guidance explicitly includes local HCPs—such as physicians, nurses, and clinics within a participant’s community—as legitimate conduits for executing trial-related activities. These providers don’t need to be formal sub-investigators unless their tasks align with their standard clinical responsibilities (e.g., taking vitals or drawing labs). This allows community health centers, retail clinics, and neighborhood providers to participate in trials. By embedding research within familiar care environments, sponsors can better reach diverse populations, increase retention, and reduce participation barriers while still operating within a compliant framework.

Mitigating Data Variability Across Locations

A recurring concern addressed by the FDA is variability in data collection. Sponsors must ensure that decentralized activities do not compromise the integrity of study endpoints.

The protocol should specify which visits will be conducted at traditional clinical trial sites, which visits will be conducted remotely, and which visits can be left to participants’ choice.

Sponsors must clearly define, from the start, how each visit will be conducted—on-site, through a home visit, at a mobile or community location, or via telehealth. Ambiguity is not acceptable. If patients can choose between visit types, that flexibility must still be laid out in the protocol. The goal is to reduce variability, ensure participant consistency, and preserve data quality. For instance, if a study allows ECGs to be collected at home or in a clinic, the protocol should explain how both options will be standardized—through training, technology, and oversight—so that data from different sources remains comparable and reliable.

IP Handling and Safety Monitoring Must Be Seamless

The guidance also addresses operational logistics critical to decentralized models:

The protocol should describe how care will be provided for adverse events that require urgent or in-person attention.

This line signals a crucial FDA expectation: decentralized trials must have a clear, proactive plan for handling medical emergencies. If something goes wrong—say a patient reacts after receiving an investigational product at home or in a mobile unit—the sponsor must have already outlined precisely who will intervene, how care will be delivered, and where the patient should go. This means:

• Sponsors must define escalation pathways (e.g., emergency contacts and procedures, tele-triage lines).
• Mobile staff should be trained to respond appropriately or transfer responsibility to local providers.
• Investigators must stay informed and ready to direct care, even remotely.

Per the FDA, DCTs can maintain high regulatory and operational standards, even when advanced therapies like gene treatments are delivered in non-traditional settings. For example, mobile nurses can ensure cold-chain integrity (critical for sensitive biologics), administer the investigational product at the patient’s home, and observe the patient post-dose for safety. Meanwhile, investigators can stay actively involved through centralized data platforms and secure messaging, enabling real-time AE tracking and rapid clinical decision-making. If an SAE occurs at the mobile unit, a crash cart should be available, and emergency procedures must already be in place to get the patient to a local ER without delay. Decentralized does not mean disconnected. With the proper infrastructure, mobile visits can match (or exceed) site-based care in safety oversight, data integrity, and patient-centricity.

Successful Community-based Research Planning Starts at Study Design

Finally, the FDA stresses that decentralized elements must be built into the protocol from the beginning, not added ad hoc.

Specific plans to facilitate decentralization of the trial should include… visits to trial participants’ homes; and direct distribution of the IP.

Sponsors must establish the operational backbone for studies, particularly in complex or large-scale trials. The FDA says it’s insufficient to send a nurse to someone’s home or set up a mobile clinic. Sponsors must think through every layer of execution. That means:

• Defining roles: Who is responsible for what? Is the mobile nurse just collecting vitals or administering a drug?
• Training procedures: Are those personnel trained to the same standards as site staff? Have they demonstrated protocol competency?
• Data flow: Where does the data go, how is it transmitted, and how do you ensure integrity across sites, homes, and mobile units?
• Risk mitigation: What happens if something goes wrong, like a cold-chain failure or an adverse event in the field?

Any inconsistency can jeopardize the study in high-stakes or large-scale trials—think oncology studies with narrow therapeutic windows or cardiovascular trials across hundreds of sites. So this section of the guidance is a call to arms for sponsors to bring site-level discipline to every decentralized touchpoint.

Summary

The FDA’s Conducting Clinical Trials with Decentralized Elements guidance formally recognizes mobile and community-based research as essential for compliant study execution. From home visits to mobile clinics to trusted local health partners, decentralized options are no longer an innovation but a regulatory reality.

To succeed, sponsors must adopt rigorous planning and execution strategies that reflect this new standard. When decentralized trial models are thoughtfully integrated, they can dramatically improve reach, retention, and representation, without sacrificing scientific or regulatory rigor.

This article is sponsored by PCM Trials.