Geography Is Destiny: The Clinical Access Gaps in Radiopharmaceutical Research
Intro
Innovation shouldn’t be limited by ZIP code. But today, it is.
Radiopharmaceuticals like Pluvicto (¹⁷⁷Lu PSMA 617) and Lutathera (¹⁷⁷Lu DOTATATE) are redefining precision oncology, yet access to clinical trials for these therapies remains uneven. While the science is advancing, the infrastructure needed to support equitable access has not kept pace.
A Map of Missed Opportunities
Access to radiopharmaceutical trials is increasingly determined by geography. Trial sites equipped to handle these complex therapies tend to cluster in urban academic centers, leaving vast regions without feasible options for patients. According to ASCO, more than 70% of U.S. counties had no reported cancer treatment trials in 2022, underscoring the structural exclusion of rural and socially vulnerable populations [1].
For radiopharmaceutical trials, these disparities are even more pronounced. Patients often need to travel long distances for trials requiring multiple imaging sessions, strict radiation handling, and dosimetry protocols. That level of logistical complexity makes participation burdensome, especially for patients with limited mobility or resources [2].
In addition to travel challenges, inconsistent access to radiation safety officers, isotopes, and therapy-trained staff can prevent otherwise qualified institutions from participating. Some sites may be willing but not equipped, and retrofitting a site for radiopharma readiness can require months of planning, licensing, and workflow alignment.
The infrastructure costs alone can be prohibitive. In many cases, establishing a radiopharmaceutical-ready site means installing shielding, purchasing specialized equipment, ensuring compliant waste handling, and training cross-functional staff. These upgrades can reach into the millions of dollars, an investment that many community or regional hospitals struggle to make without dedicated support.
Trial Recruitment Is Only Half the Story
Radiopharmaceutical studies aren’t plug-and-play. Even in areas with general oncology trial activity, radioligand therapy (RLT) trials face barriers due to the specialized infrastructure they require. A site might have oncology experience, but without radiopharmacy access, nuclear medicine expertise, radiation shielding protocols, and dosimetry integration, it isn’t RLT-capable [3].
This disconnect between trial readiness and true capability limits the number of viable sites. As a result, developers are forced to concentrate enrollment at a small number of overburdened institutions, leading to slow startup, longer timelines, and uneven enrollment [4].
The challenge extends beyond equipment. Many sites lack cross-functional coordination across radiology, nuclear medicine, pharmacy, and oncology teams. When workflows aren’t integrated, even the best-resourced sites struggle to execute consistently.
The Equity Implications Are Real
Geographic disparities in trial access translate to inequities in care. Radiopharmaceuticals often serve patients with advanced or treatment-resistant cancers. When access depends on geography, patients in underserved areas are left out, not because of clinical ineligibility, but because infrastructure doesn’t reach them [5].
PET/CT imaging, for instance, is critical to most radiopharmaceutical trials. Yet access to this modality is highly variable, particularly in rural and low-income regions. A 2025 review identified significant disparities in imaging availability, which in turn limits trial access and therapeutic equity [6].
The result is a growing divide: patients who live near academic medical centers have access to trials, while those in community or rural settings do not. Without intentional action, radiopharmaceutical innovation risks becoming another domain where geography determines outcome.
Theragnostic Insight: Infrastructure equity is strategy. Gaps in access aren't just a delivery issue, they shape what trials get done, who gets included, and how quickly innovation reaches patients. Addressing these gaps is a competitive advantage for sponsors who invest in long-term, trial-capable ecosystems.
What Can Be Done?
Addressing these clinical access gaps requires sponsors to prioritize infrastructure planning early in development. At minimum, this includes:
• Mapping regional RLT site capabilities, not just trial listings
• Evaluating patient travel feasibility and time-on-site requirements
• Supporting operational infrastructure expansion in low-access regions
• Exploring hybrid or decentralized trial frameworks when feasible
Strategic site selection isn’t just about efficiency. It’s about equity, access, and clinical excellence. By aligning protocol design with real-world conditions, sponsors can shorten timelines while reaching more patients.
At Theragnostic Insights, we help biotech teams navigate the real-world complexities of translating radiopharmaceutical science into clinical execution. We provide insight into RLT infrastructure readiness and help sponsors think through strategies for building more geographically distributed trial networks. Because in radiopharma, site access is patient access.
Stay tuned for more in this mini-series: Clinical Capacity Crisis: The Hidden Bottleneck in Radiopharma Development.
In the coming weeks, we’ll continue exploring the clinical capacity crisis holding back radiopharmaceutical innovation; from regional access gaps to operational gridlock and infrastructure blind spots. Don’t miss the next post as we map out the road to a truly trial-capable ecosystem.
1. The Trial Site Gap: Why Radiopharmaceutical Innovation Is Hitting a Wall
2. Geography Is Destiny: The Clinical Access Gaps in Radiopharmaceutical Research
3. Operational Gridlock: Where Radiopharmaceutical Trials Break Down on Site
4. Beyond the Badge: Rethinking What “Trial-Ready” Really Means in Radiopharma
5. Infrastructure as Investment Strategy: Clinical Site Access and Radiopharma ROI
6. Built for What’s Next: Redefining Clinical Site Design for Theragnostic Trials
References:
[1] Kirkwood M, Schenkel C, Hinshaw D, Bruinooge S, Waterhouse D, Peppercorn J, Subbiah I, Levit L, 2024. State of Geographic Access to Cancer Treatment Trials in the United States. ASCO
[2] Galsky M, Stensland K, McBride R, et al., 2015. Geographic Accessibility to Clinical Trials for Advanced Cancer in the United States. JAMA Internal Medicine
[3] BioPharma Dive, 2024. Radiopharmaceutical Trials: The Role of Site Selection and Support. BioPharma Dive
[4] Gu N, Elsisi Z, BPharm, Suk R, Li M, 2024. Geographic Disparity in the Distribution of Cancer Clinical Trials in the United States. Journal of Managed Care & Specialty Pharmacy
[5] Dureja S, Grana C, Bue L, Allahham T, Travaini L, Viana A, 2025. Advancing Access to Radioligand Therapies for Neuroendocrine Tumours. European Journal of Nuclear Medicine and Molecular Imaging
[6] Khan T, Khan F, Patil S, Schaison F, Subtirelu R, Revheim M, Ayubcha C, Werner T, Singh S, Alavi A, 2025. Barriers to Equitable Access: A Systematic Examination of PET/CT Imaging Disparities. Journal of Nuclear Medicine
[7] The Health Policy Partnership, 2021. Health System Readiness for Radioligand Therapy in the US: Service Provision. The Health Policy Partnership
