Clinical trials have traditionally centered on research sites, often large academic medical centers where participants travel for screening, treatment, assessments, and follow-up. Community-based clinical trials take a different approach by bringing more research activities into the healthcare settings and communities where patients already live and receive care. The National Cancer Institute has used this model for years through its Community Oncology Research Program, which brings cancer clinical trials and care delivery studies into community settings. At the same time, decentralized trial approaches have expanded the range of activities that may occur through local healthcare providers, telehealth visits, home visits, and remote technologies.

Moving research closer to patients can reduce some of the geographic and logistical barriers associated with participation. But proximity alone does not make a trial patient-friendly. Sponsors also need to think carefully about navigation, communication, technology, transportation, local provider coordination, and ongoing support if community-based clinical trials are going to work in everyday life.

Bringing Clinical Research Closer to Where Patients Receive Care

Community-based clinical trials are not necessarily the same as fully decentralized trials. A community-based model may involve community hospitals, physician practices, local health systems, or other healthcare settings conducting research closer to the patient. Decentralized elements can complement that model by allowing certain activities to happen outside a traditional research site, including telehealth appointments, home visits, remote data collection, or visits with local healthcare providers.

The common goal is to make research participation more compatible with a patient’s existing healthcare and daily life.

That matters because where a study takes place can affect who can realistically participate. Travel requirements can create significant burdens, particularly when patients must repeatedly visit distant research centers. In one study of cancer clinical trial participants, patients enrolled in Phase I studies traveled a median of more than 41 miles to reach the study site. Another nationally representative study found that transportation, childcare, or obtaining paid time off from work influenced trial participation decisions for 48.4% of respondents.

Reducing those barriers can open research opportunities to people for whom a distant academic site may be impractical.

Access Requires More Than Moving the Trial

Locating more research activities in community settings solves only part of the access problem.

A patient still has to learn that a study exists, understand what participation involves, determine whether the opportunity is realistic, complete screening requirements, communicate with a study team, attend necessary visits, and follow study procedures over time. Each step creates an opportunity for a patient to encounter confusion or logistical friction.

For sponsors developing community-based clinical trials, access should therefore be considered across the entire patient journey.

A potential participant may need help understanding where an appointment is taking place. Another may need a laboratory test completed locally before being referred. Someone else may have difficulty arranging transportation, accessing a digital study platform, or fitting appointments around work and caregiving responsibilities.

These challenges are significant because trial participation often asks patients to accommodate research on top of their existing medical and personal responsibilities. Financial burden can also increase with travel. A 2024 study of cancer trial participants found that those traveling more than an hour to their cancer provider had more than twice the risk of financial hardship compared with those traveling 30 minutes or less, after adjustment for several demographic and socioeconomic factors.

Community-based models are most meaningful when they reduce the total burden of participation, rather than simply changing the address where research occurs.

Patient Navigation Connects the Pieces

Patient navigation becomes especially important when trial activities are distributed across several settings.

In a traditional site-centered model, much of the participant experience may be coordinated through one research team. In a community-based or hybrid model, a participant could interact with a local physician, central study team, laboratory, pharmacy, transportation provider, digital platform, and remote support team.

Without coordination, flexibility can become fragmentation.

A consistent navigation resource can help participants understand what happens next, where they need to go, what they need to complete, and whom they should contact when something changes. Navigation can also help close gaps between referral and enrollment by following up with patients after screening, helping coordinate pre-referral testing, confirming appointments, and addressing practical barriers before they become missed study milestones.

Evidence from community-based research demonstrates the value of designing support around local populations. One cancer trial that recruited participants across urban and rural sites identified transportation, childcare, work responsibilities, language, trust, and access to an academic cancer center as key enrollment barriers. The study used tailored community and patient engagement strategies and achieved a 79% enrollment rate among eligible participants who were not subsequently determined to be ineligible.

The broader lesson is not that one navigation model works everywhere. It is that patient support should reflect the realities of the communities a trial intends to reach.

Decentralized Technology Still Needs Human Support

Technology is another important component of community-based clinical trials, particularly when sponsors incorporate decentralized elements.

Digital health technologies can allow certain clinical data to be collected remotely and may increase opportunities to participate while making participation more convenient. Telehealth can reduce the need for some in-person visits, while digital tools can support questionnaires, reminders, diaries, monitoring, and other study activities outside the research center.

But moving a task onto a smartphone or wearable does not automatically eliminate burden.

Participants may need onboarding, device training, password assistance, reminders, troubleshooting, or clarification about when and how data should be collected. Some patients may be highly comfortable with digital technology while others need more assistance. Community-based trials should be designed for both.

Human support is particularly important when technology creates a new responsibility for the participant. A digital tool intended to simplify a study can have the opposite effect if patients do not understand how to use it or cannot quickly get help when something goes wrong.

The most practical model is often one in which technology handles what it does well, such as reminders, remote data capture, status tracking, and routine communications, while trained support professionals remain available for questions, problem-solving, and situations requiring human judgment.

Supporting Community Sites Without Adding Site Burden

Community-based clinical trials also have to work for the healthcare professionals delivering them.

Local physicians and healthcare teams may have deep relationships with patients, but many community practices do not have the same research infrastructure as large academic centers. Expanding research into these settings without providing adequate operational support risks shifting administrative work onto already busy clinical teams.

The NCI community oncology model illustrates the importance of infrastructure. Its network connects community hospitals and oncology practices with research bases that provide scientific and operational support, allowing research to be conducted in settings where patients receive their care.

Sponsors should apply the same principle when designing community-based programs. Local sites need clear processes for referrals, participant status updates, escalation, documentation, scheduling, and communication with central study teams.

Patient support can relieve some of this pressure. Pre-screening assistance, referral management, appointment coordination, patient follow-up, transportation support, and end-to-end tracking can prevent routine communication tasks from accumulating at the site level. These functions are already part of established clinical trial patient-support models designed to connect participants and investigative sites throughout recruitment and retention.

Modern good clinical practice also emphasizes flexible, risk-based trial approaches while maintaining participant protection, clear sponsor and investigator responsibilities, and reliable results. Community-based execution should therefore simplify unnecessary burden without weakening oversight or introducing ambiguity about responsibilities.

Designing Community-Based Clinical Trials Around Real Life

The promise of community-based clinical trials is not simply that participants travel fewer miles. It is that research can become more connected to the way people actually receive healthcare.

Sponsors can begin by looking at the trial from the participant’s perspective. Which visits truly require a specialized research center? Which activities can safely occur with a local healthcare provider? Can certain data be collected remotely? Are instructions understandable? What happens if a participant misses a call? Is transportation assistance available when an in-person visit is unavoidable? Who helps a patient when a digital tool does not work?

Those questions should be addressed during study design rather than after recruitment begins.

Regulatory thinking increasingly supports trial approaches that expand participation, use flexible technologies, and integrate appropriate research activities into convenient settings while preserving safety and data quality. Enrollment strategies are also expected to consider characteristics such as location of residence so study populations can more closely reflect the patients who may eventually use a medical product.

Community-based clinical trials offer an opportunity to make that principle operational.

Bringing Research Into the Patient’s World

Expanding clinical research beyond major research centers can create meaningful opportunities for patients who have historically faced geographic, logistical, financial, or practical barriers to participation. Community-based clinical trials can bring research closer to routine healthcare, while decentralized elements can further reduce unnecessary travel and make participation more flexible.

But success depends on what surrounds the trial.

Clear communication, patient navigation, local healthcare coordination, thoughtful use of technology, transportation assistance, consistent follow-up, and accessible human support all help turn a community-based protocol into a workable patient experience.

The goal should not simply be to move clinical research outside the traditional site. It should be to build research around patients’ real lives while maintaining the quality, safety, and rigor that clinical trials require. That is where community-based clinical trials have the greatest potential to expand access and make participation more practical for the people research ultimately depends on.