The Community Site Opportunity: Expanding Radiopharma Trials Beyond Academic Centers

Radiopharma trials are concentrated in academic centers. That concentration is slowing development.

Academic medical centers have played an essential role in advancing radiopharmaceutical therapies. They bring together nuclear medicine expertise, specialized infrastructure, experienced investigators, imaging capabilities, and radiation safety programs under one roof.

But as radiopharmaceutical pipelines grow, the same concentration that supported early development can become a constraint. A limited pool of experienced sites means sponsors may compete for investigators, treatment capacity, and eligible patients. For patients, participation may require significant travel to reach an academic center.

Community oncology centers could help expand that clinical footprint. The opportunity is compelling—but expanding clinical trial sites requires more than adding locations to a feasibility list.

Why Community Expansion Matters

Radiopharmaceutical development is moving into a broader range of targets, radionuclides, and therapeutic approaches. Zhang et al. describe the evolution from established agents such as [¹⁷⁷Lu]Lu-DOTA-TATE and [¹⁷⁷Lu]Lu-PSMA-617 toward investigational platforms targeting FAP, integrins, CXCR4, GRPR, and other emerging targets.[1]  

As development activity increases, clinical infrastructure must grow with it.

Community oncology radiopharmaceutical trials offer one pathway toward that growth. Community centers may provide access to patient populations outside major metropolitan academic hubs, reduce travel burden, and create additional capacity for enrollment.

The strategic question is therefore less about whether community sites can participate and more about which sites are ready, which can become ready, and what it will take to support them.

Radiopharmaceutical Readiness Is Different

Traditional oncology site feasibility often focuses on patient volume, investigator experience, competing trials, staffing, and equipment. Those factors still matter, but radiopharmaceutical studies add another operational layer.

The investigational product contains a radionuclide with physical characteristics that directly influence clinical use. Half-life, radiation type, production method, and imaging or therapeutic application vary substantially across radionuclides.[1] For example, Zhang et al. report a half-life of approximately 68 minutes for gallium-68 compared with 6.65 days for lutetium-177.  

Those properties translate into practical site requirements.

A participating center may need appropriate radioactive materials licensing, radiation safety procedures, trained nuclear medicine personnel, secure receipt and handling processes, imaging access, radioactive waste management, and workflows capable of coordinating drug delivery with the patient’s treatment schedule.

A community oncology center may be clinically strong while still having gaps in one or more of these areas.

Theragnostic Insight: Site feasibility should distinguish between structural barriers and trainable capabilities. A site without the necessary infrastructure presents a different challenge from a capable center that needs protocol-specific training and workflow development.

Build the Site Network Before Enrollment Depends on It

Expanding clinical trial sites successfully requires planning earlier than site activation.

Sponsors should map the complete treatment pathway: isotope production and distribution, investigational product receipt, patient preparation, administration, imaging where required, radiation safety, dosimetry requirements, post-treatment procedures, and data capture.

That exercise can reveal where community participation is realistic and where targeted investment may close readiness gaps.

It also changes how sponsors think about site selection. Rather than repeatedly competing for the same established academic centers, development teams can identify promising community institutions and create structured pathways for qualification, training, and activation.

The goal is not to reproduce an academic medical center at every location. It is to determine the capabilities the protocol actually requires and build a network that can execute those requirements consistently.

Access and Execution Have to Advance Together

Community expansion also has a patient-centered rationale. A radiopharmaceutical trial available only at a distant academic institution may technically be open to a patient while remaining practically difficult to access.

Bringing studies closer to where patients already receive oncology care could reduce some of that burden. Yet geographic expansion only creates meaningful access when sites can execute safely and reliably.

That makes operational readiness central to trial access—not separate from it.

For sponsors, this means community expansion should be integrated into protocol design, site feasibility, supply-chain planning, training, and activation strategy from the beginning. Waiting until enrollment slows to search for additional sites can leave little time to develop the specialized capabilities radiopharmaceutical trials require.

What This Means for You

The next stage of radiopharmaceutical development will require more than additional compounds. It will require additional clinical capacity.

Community oncology centers represent an opportunity to broaden patient access and build a more scalable research ecosystem. Capturing that opportunity requires a deliberate approach: identifying capable partners, understanding site-level gaps, and building the operational infrastructure necessary for reliable execution.

Theragnostic Insights helps development teams connect these pieces early—translating radiopharmaceutical science into practical site, operational, and clinical development strategies.

Because expanding the site network is ultimately about more than adding dots to a map. It is about building the capacity needed to move promising radiotherapies from concept to clinic.

References

[1] Zhang S, Wang X, Gao X, et al., 2025. Radiopharmaceuticals and their applications in medicine. Signal Transduction and Targeted Therapy, 10:1.  

[2] U.S. Food and Drug Administration, 2024. Integrating Randomized Controlled Trials for Drug and Biological Products Into Routine Clinical Practice: Draft Guidance for Industry.

[3] Society of Nuclear Medicine and Molecular Imaging. Radiopharmaceutical Therapy Centers of Excellence Program.

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