Clinical Trials Closer to Home: Closing the Community Oncology Access Gap

For many patients with cancer, access to a clinical trial still depends on where the trial is located, not just whether a potentially appropriate study exists. Expanding trial infrastructure into community oncology practices could bring biomarker-driven research closer to the patients already receiving most of their cancer care.

Key Takeaways

• Most cancer care is delivered in the community, while clinical-trial infrastructure remains concentrated in a smaller number of academic and research centers. Approximately 80%–85% of patients with cancer receive care in community-based practices, yet access to therapeutic trials remains substantially more limited in these settings. [1,2]
• Geography is a measurable barrier to trial access. A 2024 analysis found that 70% of U.S. counties had no active cancer treatment trials in 2022, with substantially greater gaps in nonmetropolitan counties (86%). [3]
• When patients are offered a trial, many are willing to participate. A systematic review and meta-analysis of 35 U.S. studies found that 55.0% of patients offered a cancer clinical trial agreed to participate, underscoring the importance of addressing barriers before offering a trial. [4]

Bringing Precision Clinical Trials Into Community Oncology
Most patients with cancer receive their care in community oncology practices, yet access to clinical trials remains concentrated in a relatively small number of research centers. The geographic gap is substantial: an analysis of U.S. phase I–III cancer treatment trials found that 70% of U.S. counties had no active cancer treatment trial in 2022, including 86% of nonmetropolitan counties compared with 44% of metropolitan counties. A separate analysis of nearly 15,000 phase 1-3 trials conducted from 2008 through 2022 found that only 42.4% of U.S. counties had at least one cancer clinical trial during that period, with rural counties and counties with fewer medical oncologists significantly less likely to have a trial. [1][2][3]

Patient willingness is another part of the equation, but the evidence suggests limited participation cannot be attributed solely to patients declining trials. A systematic review and meta-analysis of 35 U.S. studies involving 9,759 patients, published in the Journal of the National Cancer Institute, found that 55% of patients offered a clinical trial agreed to participate. The authors identified modifiable systemic, structural, and clinical barriers—including access to available trials—as important areas for improving participation. [3][4][5]

For community oncologists, the challenge is increasingly connected to precision oncology. Molecular profiling can identify rare, potentially actionable alterations, but identifying a biomarker is only useful if it can be connected to an appropriate treatment or clinical trial within the patient’s treatment window. Community practices may face substantial operational barriers even when their physicians have the expertise and patient populations needed to conduct trials. At the same time, research-active community practices have demonstrated that clinical trials can be integrated into local oncology care when the necessary infrastructure is available. [2][6]

In our interview, Christopher Vaughan, MD, a community oncologist with Hematology Oncology Associates of Fredericksburg in Virginia, discusses how his practice is addressing this challenge. He describes the practical realities of identifying rare mutations, integrating trial matching into routine clinical workflow, and bringing advanced clinical-trial opportunities closer to patients who might otherwise need to travel to an academic cancer center.

Danielle Garcia: From your vantage point as a community oncologist who has watched this field evolve, what has actually changed about how treatment decisions get made?

Christopher Vaughn, MD: Treatment decisions have evolved beyond tumor type, stage, and line of therapy. We routinely consider molecular and genomic findings, patient-specific factors and preferences, comorbidities, and available clinical-trial opportunities when developing a treatment plan. As oncology becomes increasingly specialized, we continually adapt our approach to incorporate advances in treatment while ensuring recommendations are individualized to each patient’s clinical needs and goals.

DG: Most cancer patients receive care in community practices, yet that’s rarely where trials are held. Beyond the obvious logistical hurdles, what is the deeper structural reason?

CV: The clinical research infrastructure has historically been built around large academic medical centers rather than where the majority of patients receive their cancer care. Trial infrastructure, contracting processes, staffing, and financial resources remain largely concentrated within these institutions. However, many community oncology practices have developed sophisticated research programs and are increasingly capable of successfully enrolling and managing patients on clinical trials. Providing access to cutting-edge clinical trials is an important component of high-quality cancer care, and community sites can often achieve strong enrollment and trial-management outcomes despite having fewer resources than larger academic centers. [2][6]

DG: Rare but actionable mutations can be easy to miss. How has your ability to identify them changed, and what does catching one set in motion?

CV: Broad molecular profiling and more systematic testing have made rare alterations easier to identify. When we find one, it can immediately change the treatment conversation and trigger a search for an approved targeted therapy, an off-label option, or a biomarker-selected trial. The key is connecting the result to an actionable next step rather than allowing it to remain buried in a report. And of course you need to use tests designed to find rare alterations. Comprehensive profiling platforms like Caris Life Sciences are built specifically to catch them and can make a huge difference.

DG: Oncology decisions often must be made within days or weeks, while opening a trial has traditionally taken months. How do you weigh a trial against that clinical window?

CV: The patient’s clinical window has to drive the decision. We evaluate clinical trial opportunities in parallel with standard-of-care treatment rather than waiting to determine whether a trial will become available. The patient’s disease tempo, symptoms, prior treatment history, and overall clinical condition all factor into how much time we realistically have.

If a trial can be identified, screened, and activated within an appropriate treatment window, we consider it alongside standard therapy. However, we cannot delay necessary treatment simply to pursue a trial that may not become available in time. In the community setting, efficiency is particularly important, so having streamlined contracting, rapid feasibility and screening processes, and readily available trial infrastructure can make a meaningful difference in whether a patient is actually able to participate.

DG: When a match surfaces, what does acting on it look like day to day? What has changed in your workflow?

CV: When a potential trial match is identified, the process has to move quickly. Our workflow typically involves reviewing the patient’s diagnosis, biomarker and molecular results, prior lines of therapy, current clinical status, and the specific eligibility criteria to determine whether the trial is a realistic option. From there, the clinical and research teams communicate directly to confirm eligibility, review the trial with the patient, and begin the screening process if appropriate.

What has changed is that trial identification and consideration are becoming much more integrated into routine clinical workflow. Rather than waiting until standard treatment options have been exhausted, we are looking for appropriate trials earlier and evaluating them alongside available therapies. This requires close coordination between the oncologist, research staff, pathology, radiology, and other departments, as well as faster access to records, molecular testing, and trial information. In practice, the goal is to move from identifying a potential match to determining feasibility and initiating screening as efficiently as possible without disrupting the patient’s treatment plan.

DG: What has it meant for a patient to reach an advanced trial option without leaving your practice? What does staying close to home change?

CV: For patients, having access to an advanced clinical trial within their local oncology practice can make a significant difference. We have had a patient who would otherwise have needed to travel to MD Anderson in Texas to access a particular trial. We were able to open the trial at our site, working with Caris’s Right-in-Time Trials network to get it opened quickly, so the patient could receive treatment closer to home.

Being able to offer that option locally eliminated a substantial travel burden and reduced the financial and logistical challenges associated with traveling out of state for treatment. It also allowed the patient to remain with a care team they already knew and trusted, while still having access to an advanced treatment option. For many patients, the ability to participate in a clinical trial without leaving their community can make the difference between a trial being realistically accessible and not being an option at all.

DG: What will it take for community-based precision oncology and local trial access to become the standard, and what must the field stop doing?

CV: For community-based precision oncology and local clinical-trial access to become the standard, the field needs to recognize community practices as essential partners in clinical research rather than viewing trials primarily through an academic-center model. This requires greater investment in community research infrastructure, streamlined contracting and regulatory processes, access to molecular testing and actionable data, adequate staffing, and financial models that make trial participation sustainable for community practices.

We also need stronger collaboration between academic institutions, sponsors, and community sites so that appropriate trials can be opened where patients are actually receiving care. Trial designs and operational requirements should be practical enough to allow qualified community practices to participate without creating unnecessary barriers.

The field needs to move away from the assumption that advanced or precision clinical trials must be concentrated at major academic centers. We also need to stop allowing administrative complexity and lengthy activation timelines to limit patient access. If we want precision oncology to truly be patient-centered, access to appropriate trials needs to be timely, geographically accessible, and integrated into routine oncology care—not something patients have to travel across the country to obtain.

DG: Is the community oncology access gap uniquely American? What are colleagues in other markets dealing with?

CV: No. Geography magnifies the problem in the United States, but the underlying issue is global: specialized diagnostics and trials remain concentrated in a relatively small number of centers. Other markets also face uneven testing, fragmented referral pathways, reimbursement constraints, workforce limitations, and slow regulatory or contracting processes. The details differ, but the central challenge is the same—bringing research capabilities to patients rather than expecting every patient to travel to the research system.

References

[1] Birhiray RE, Birhiray MN. Clinical research in the community. Hematology Am Soc Hematol Educ Program. 2023 Dec 8;2023(1):324-331. doi: 10.1182/hematology.2023000432. PMID: 38066876; PMCID: PMC10727107.
[2] Altomare I, Wang X, Kaur M, Guadamuz JS, Falk S, Xiao F, Meropol NJ, Zhao Y. Are community oncology practices with or without clinical research programs different? A comparison of patient and practice characteristics. JNCI Cancer Spectr. 2024 Jul 1;8(4):pkae060. doi: 10.1093/jncics/pkae060. PMID: 39041606; PMCID: PMC11310105.
[3] Kirkwood MK, Schenkel C, Hinshaw DC, Bruinooge SS, Waterhouse DM, Peppercorn JM, Subbiah IM, Levit LA. State of Geographic Access to Cancer Treatment Trials in the United States: Are Studies Located Where Patients Live? JCO Oncol Pract. 2025 Mar;21(3):427-437. doi: 10.1200/OP.24.00261. Epub 2024 Oct 2. PMID: 39356976; PMCID: PMC11925346.
[4] Unger JM, Hershman DL, Till C, Minasian LM, Osarogiagbon RU, Fleury ME, Vaidya R. “When Offered to Participate”: A Systematic Review and Meta-Analysis of Patient Agreement to Participate in Cancer Clinical Trials. J Natl Cancer Inst. 2021 Mar 1;113(3):244-257. doi: 10.1093/jnci/djaa155. PMID: 33022716; PMCID: PMC7936064.
[5] Geographic disparity in the distribution of cancer clinical trials in the United States and the associated factors. Cancer. 2024. PMID: 38555628.
[6] Kim DJ, Otap D, Ruel N, Gupta N, Khan N, Dorff T. NCI-Clinical Trial Accrual in a Community Network Affiliated with a Designated Cancer Center. J Clin Med. 2020 Jun 24;9(6):1970. doi: 10.3390/jcm9061970. PMID: 32599694; PMCID: PMC7355880.

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