Most patients with cancer never have the opportunity to participate in a clinical trial—not because physicians fail to discuss research, but because an appropriate study is often unavailable when treatment decisions need to be made. Eligibility requirements, geography, timing, and site availability frequently intersect to make trial participation impractical or impossible.
The geographic disparities are well documented. In 2022, 70% of U.S. counties had no active cancer treatment trial. Those counties encompassed 74% of the nation’s land area and nearly one in five Americans aged 55 years and older—the population in which most cancers are diagnosed. Many of these communities also experience disproportionately high cancer burdens and greater social vulnerability. At the same time, most patients with cancer receive their care in community oncology practices, which face unique challenges to offering trials compared to academic cancer centers.[1]
For many patients, the opportunity to participate in research is lost before it is ever considered.
Timing Is a Clinical Challenge
Oncology treatment decisions occur within narrow clinical windows. At the time of diagnosis, recurrence, or disease progression, treatment plans are often finalized within days or weeks. Once therapy begins, eligibility for many studies changes or disappears altogether. By the time an appropriate trial is identified—or a referral is completed—the window for enrollment may already have closed.
This clinical reality contrasts sharply with the operational timelines that govern trial activation. Conventional site activation often requires months to complete. One benchmarking survey reported a median activation time of 167 days, substantially longer than the National Cancer Institute’s target of 90 days, while published reports from NCI-designated centers continue to demonstrate wide variation. [2]
The challenge is therefore not simply identifying an appropriate trial, but identifying it early enough for it to influence a treatment decision.
Trial Matching Should Be Longitudinal, Not Episodic
Clinical trial matching has traditionally been viewed as a one-time event, often occurring only after standard treatment options have been exhausted. In practice, however, patient eligibility evolves throughout the course of disease.
New biomarkers emerge. Prior therapies accumulate. Performance status changes. New studies open while others close. A patient who is ineligible today may become an ideal candidate months later.
Rather than relying on episodic searches, trial matching should be viewed as a longitudinal process that follows patients throughout their care journey. Identifying potential trial opportunities before they are urgently needed allows physicians and patients to consider research alongside standard treatment options, rather than as a last resort.
Comprehensive Molecular Profiling Is an Essential Foundation
Comprehensive molecular profiling has become an increasingly important component of precision oncology and clinical trial enrollment. By complementing conventional pathology with genomic, transcriptomic, and protein biomarker information, comprehensive profiling can identify molecular features that inform prognosis, therapeutic selection, and eligibility for biomarker-driven studies.
However, molecular profiling alone is not sufficient.
Effective trial matching requires integration of molecular findings with histology, stage, prior therapies, performance status, laboratory parameters, and increasingly complex protocol-specific eligibility criteria. Matching is therefore both a molecular and clinical exercise.
As biomarker-driven trials continue to expand, ensuring that molecular findings are connected to relevant treatment opportunities becomes increasingly important.
Rare genomic alterations illustrate this challenge. Neurotrophic tyrosine receptor kinase (NTRK) gene fusions, for example, occur infrequently across many tumor types but have highly effective targeted therapies available. Yet real-world analyses suggest that many patients with these rare alterations do not receive matched therapies. [3] Multiple factors likely contribute, including the rarity of these events, limited clinical familiarity, logistical barriers, and the difficulty of identifying eligible patients at the point of care. The existence of an actionable biomarker alone does not ensure access to the right therapy or the right clinical trial.
Strengthening Clinical Research in the Community
The greatest opportunity to improve trial access lies where most patients already receive their care.
Community oncologists manage extraordinarily complex patients while balancing busy clinical practices. Expecting every practice to independently monitor thousands of actively recruiting studies across multiple sponsors is neither practical nor sustainable.
Instead, research infrastructure should evolve to support community practices by simplifying trial identification, reducing administrative burden, and facilitating participation without requiring patients to transfer their care unnecessarily.
Distance remains a significant barrier. Many older adults must travel several hours to reach academic centers offering broad clinical trial portfolios. For patients receiving ongoing systemic therapy, repeated long-distance travel may not be feasible and can create substantial burdens for patients and caregivers alike. [4]
Whenever possible, clinical research should move closer to patients—not the other way around.
Making Trial Access Timely
Improving access requires more than finding the right trial; it requires finding it at the right time.
An effective matching system identifies potentially eligible patients early, continuously reassesses eligibility as disease and treatment evolve, and alerts treating physicians while meaningful therapeutic decisions remain available.
Rather than functioning as a series of isolated patient searches, trial matching should operate as a population health activity. Patients who undergo comprehensive molecular profiling can be continuously prescreened against an evolving portfolio of clinical trials, creating a trial-ready population whose eligibility is reassessed as new studies open, treatments change, or disease progresses. This shifts matching from a reactive process to a proactive one.
Experienced research nurses and clinical navigators remain essential to this model, reviewing eligibility, coordinating records, and following patients over time until enrollment becomes clinically appropriate.
Equally important are research-ready community networks capable of activating studies efficiently. Centralized contracting, standardized regulatory processes, and established infrastructure can eliminate much of the administrative delay that has traditionally slowed trial enrollment. By performing operational activities in parallel rather than sequentially, enrollment timelines can be substantially shortened while allowing patients to remain under the care of their local oncology teams whenever appropriate.
The goal is not simply faster enrollment. It is ensuring that clinical trial participation becomes a realistic option during the period when treatment decisions are actually being made.
A Call to the Oncology Community
The gap between scientific innovation and patient access is no longer primarily a discovery problem. Increasingly, it is an implementation problem.
We have made remarkable advances in molecular characterization, precision therapeutics, and biomarker-driven drug development. Yet too many patients never benefit from these advances because clinical trials remain inaccessible at the point where care is delivered.
Improving access will require collaboration across the oncology ecosystem. Sponsors can continue designing studies that are feasible to conduct in community settings. Health systems can invest in research-ready infrastructure. Technology can simplify patient identification. And clinicians can incorporate comprehensive molecular profiling and ongoing trial assessment as routine components of high-quality cancer care.
Ultimately, success should not be measured solely by enrollment at individual institutions, but by whether every patient—regardless of where they live or receive care—has a meaningful opportunity to participate in research when it is clinically appropriate.
Access to innovation should depend on a patient’s clinical characteristics—not their ZIP code.
References
[1] Tallent A. New Oncology Workforce Data Point to Widespread Concerns. Oncology News Central. Online. Last accessed September 1, 2026
[2] Smith S. Accelerating Clinical Trial Activation. June 21, 2024. Online. Last accessed on September 1, 2026.
[3] Sledge GW Jr, Yoshino T, Xiu J, Helmstetter A, Ribeiro JR, Klimov S, Gilg B, Gao JJ, Elton J, Oberley MJ, Radovich M, Abraham J, Spetzler D. Real-world evidence provides clinical insights into tissue-agnostic therapeutic approvals. Nat Commun. 2025 Mar 18;16(1):2646. doi: 10.1038/s41467-025-57941-0. PMID: 40102447; PMCID: PMC11920432.
[4]Cancer Clinical Trials Continue to be Out of Reach for Many Patients. ASCO. October 2, 2024.Online. Last accessed on September 1, 2026.
Featured image
DOI
