Decentralized clinical trial approaches, including remote consent, telehealth, local laboratory and imaging services, and more, can help reduce some of the many barriers that prevent eligible patients from participating in trials. But as the participants in ACCC’s Advancing Decentralized Clinical Trials in the Community Setting Roundtable Series emphasized, implementing DCT elements is not simply a matter of adopting new technology. Doing so successfully requires thoughtful workflows and oversight structures that consider equity, scalability, and sustainability.
For many patients with cancer, the opportunity to participate in a clinical trial is shaped by far more than eligibility criteria. Distance from a research center, transportation needs, time away from work, caregiving responsibilities, access to local services, and comfort with technology can all determine whether participation is realistically possible.
Decentralized clinical trial (DCT) approaches, including remote consent, telehealth, local laboratory and imaging services, digital health technologies, and mobile health professionals, can help reduce some of these barriers. But as the participants in ACCC’s Advancing Decentralized Clinical Trials in the Community Setting Roundtable Series emphasized, implementing DCT elements is not simply a matter of adopting new technology.
To make decentralized research both equitable and sustainable, community oncology programs need practical workflows, clear oversight structures, engaged sponsors, prepared staff, and organizational cultures that support innovation. The final roundtable in the series explored these issues through the lenses of equity, scalability, and sustainability, which resulted in a central message: Distance equals disparity.
The promise of decentralization is often framed in terms of convenience, but its implications are more significant. For patients in rural, frontier, and medically underserved communities, geographic distance can limit access to routine oncology care and create an even greater obstacle to clinical-trial participation.
One roundtable participant described results from a 2021 community survey in the Mountain West health system serving rural and frontier populations: Approximately 89% to 90% of rural respondents were unaware of clinical trials. The finding highlights an essential point: Improving access requires more than bringing trial-related activities closer to home. Patients and communities also need opportunities to learn about clinical research well before a trial becomes an immediate treatment option.
“A patient should never hear the words clinical trial for the first time when they need one.” — Roundtable participant
Community outreach, community advisory boards, patient advocates, culturally responsive recruitment materials, and patient representation in trial-review processes can help build awareness and trust. These strategies require time and resources, but roundtable participants viewed them as essential for meaningful engagement with populations that have historically been underserved in clinical research.
FDA guidance on enhancing participation in clinical trials encourages approaches that can broaden access, including digital health technologies, telehealth, remote consent, mobile health professionals, geographic diversity, culturally competent recruitment, and reimbursement of reasonable patient costs. Roundtable participants welcomed these signals but emphasized that high-level guidance does not provide the day-to-day road map needed to implement DCT elements across diverse oncology settings. Community programs must still navigate technology standards, investigational-product logistics, institutional risk tolerance, and the division of responsibilities among research sites and external care partners.
The relevant question, then, is not whether to decentralize an entire study, but which elements can be implemented safely and feasibly for a specific protocol, patient population, and site. These might include protocol-permitted laboratory testing or imaging at local facilities, telehealth follow-up visits, remote consent, utilizing mobile health professionals, or other strategies that allow patients to complete appropriate study activities closer to home.
A right-sized model recognizes that decentralization is not all-or-nothing. The goal is to reduce avoidable burden while maintaining patient safety, protocol fidelity, data quality, and meaningful patient choice.
Technology can expand access, but the roundtable discussion made it clear that technology itself can also introduce burden. Rather than converging on a smaller set of interoperable systems, the research technology landscape has become increasingly fragmented. Participants reported that sites may be asked to manage 12 or more platforms, each with separate training expectations, security reviews, and sponsor-specific requirements.
This fragmentation is particularly challenging for community sites with limited research staff and information-technology capacity. A new platform may be technically capable of supporting decentralized study activities, but it will not be sustainable if it creates duplicative work, disrupts existing workflows, or requires staff to master yet another system without adequate training and support.
Participants emphasized that successful technology adoption depends on “staff pull, not push.” In other words, coordinators and other users are more likely to adopt a tool when they understand how it improves their work, not when they are simply required to use yet another platform. Sandbox training, workflow simulations, and early user involvement can help clinical staff identify problems before implementation affects a live study or patient.
Even programs experienced with eConsent, telehealth, or remote phlebotomy may encounter a different combination of regulatory, logistical, technological, and patient-care requirements with every new study. As one participant put it: “Every trial is a snowflake, and when you add all these things in, you…get into a snowstorm.”
Sustainable DCT adoption, therefore, cannot rest solely on a small group of specialized staff. Programs need repeatable processes, clear governance, institutional knowledge, engaged physician champions, and organizational leadership.
Larger institutions may also help community sites participate by centralizing functions such as institutional review board coordination, contracting, standard operating procedures, pharmacy support, and data management while allowing local teams to focus on patient-facing activities.
Reducing travel and time burdens is an important component of equitable access to clinical trials, but even well-intentioned support can have unintended consequences. Roundtable participants raised concerns that clinical trial stipends intended to make participation easier may be treated as taxable income, potentially affecting eligibility for safety-net programs such as Medicaid or the Supplemental Nutrition Assistance Program.
Financial support intended to make trial participation feasible should not inadvertently place patients at risk of losing essential benefits. Participants identified the Clinical Trial Modernization Act, H.R. 4184 as a potential policy response to address these concerns and protect access to certain financial and nonmedical supports associated with clinical trial participation.
There is no single DCT model that will work for every community oncology program. Patient populations, geography, staffing, technology infrastructure, research portfolios, partnerships, and institutional resources vary widely.
What emerged from the ACCC roundtable discussions was not a call for complete decentralization, but for a more flexible, context-specific approach to clinical research—one that asks where unnecessary burdens can be reduced without compromising safety, quality, or patient choice.
Decentralized clinical trials have the potential to bring research opportunities closer to the people who need them. Realizing that potential will require more than technology. It will require intentional design, reliable infrastructure, engaged champions, and a sustained commitment to making clinical research accessible, practical, and patient-centered.
Acknowledgment
This program is made possible with support from Gilead, Lilly, and Merck.
