The Trial Site Gap: Why Radiopharmaceutical Innovation Is Hitting a Wall
Intro
Radiopharmaceuticals are evolving fast, yet the clinical trial system hasn’t kept pace.
Even as promising agents like Pluvicto (¹⁷⁷Lu PSMA 617) and Lutathera (¹⁷⁷Lu DOTATATE) gain regulatory approval, dozens more are stuck in early development. They don’t lack potential. The problem is that there aren’t enough clinical trial sites prepared to run these complex studies.
The science is ready. The infrastructure isn’t.
A Pipeline With No Place To Go
Radiopharmaceuticals have moved from niche innovation to one of the fastest-growing segments of precision oncology. In just the last decade, over 360 new clinical trials have launched globally, with growing interest in therapies for prostate cancer, neuroendocrine tumors, CNS malignancies, and more [1]., with growing interest in therapies for prostate cancer, neuroendocrine tumors, CNS malignancies, and more.
But only about 10% of these trials have reached Phase III, and even fewer have completed with successful endpoints [1]. A large part of the slowdown isn’t due to the molecules themselves; it is rooted in operational challenges. Programs stall because they can’t find trial sites with the necessary infrastructure to manage radioactive drugs, complex scheduling, or regulatory oversight.
And as the pipeline shifts toward alpha emitters and increasingly individualized dosimetry models, the burden on trial sites will only grow.
Why Most Trial Sites Aren't Ready
Radiopharmaceutical trials demand a highly coordinated environment. These therapies involve time-sensitive radioactive materials, cross-disciplinary workflows, and strict regulatory controls. Each of these elements must operate in sync to protect patient safety and meet protocol requirements.
You don’t just need an imaging center. You need:
• A licensed radiopharmacy or on-site isotope delivery pathway
• Integrated PET/SPECT imaging with therapy scheduling
• Credentialed nuclear medicine staff
• Radiation safety infrastructure and compliance
• Real-time dosimetry and coordination across departments
• Dedicated imaging outisde of routine clinical needs.
When Lutathera was first approved in 2018, uptake lagged significantly. This wasn’t due to clinical hesitation, but because most treatment centers simply weren’t equipped to deliver it [2]. That same problem now looms larger as the volume and complexity of radiopharmaceutical trials increases.
Today, sponsors must build trials for a landscape where capable sites are the exception, not the rule.
Site Selection Is Now a Strategic Imperative
Traditional trial site selection models are no longer sufficient. Radiopharmaceuticals require sponsors to go beyond feasibility questionnaires and consider whether a site is truly trial-capable and not just trial-listed.
Key readiness factors include:
• On-site or contracted radiopharmacy capabilities
• Regulatory authorization to handle investigational radiotherapeutics
• Prior experience running RLT trials
• Trained staff across nuclear medicine, oncology, and pharmacy
• Coordination between imaging and therapeutic scheduling
According to recent data, early alignment between sponsors and site operational teams significantly improves trial efficiency and protocol compliance [3]. Failing to assess these factors upfront can lead to avoidable protocol deviations, startup delays, and screen failures.
Theragnostic Insight: Trial-ready ≠ trial-capable. Infrastructure is no longer a background concern. It is a primary driver of radiopharmaceutical trial success and serves as a key differentiator for sponsors who address it early.
A Risk Hiding in Plain Sight
For biotech teams and investors alike, trial site availability represents a hidden vector of risk. It directly affects:
• Time to first patient and downstream trial activation timelines
• Geographic reach, limiting patient recruitment and enrollment diversity
• Trial cost, with added burden on sponsor teams to support under-equipped sites
• Regulatory exposure, especially when sites face delays related to radiation safety or handling
A recent analysis in The Lancet Oncology noted that despite the clinical momentum behind radiopharmaceuticals, infrastructure and workforce constraints could slow the entire field unless addressed in parallel with drug development [4].
What This Means for You
If you're developing a radiopharmaceutical asset, site access isn’t merely a logistical concern. It is a strategic priority. To stay competitive, sponsors should:
• Start identifying radiopharma-experienced sites early, ideally pre-IND
• Assess not just staff and equipment, but actual RLT operational workflows
• Consider geographic infrastructure limitations when choosing trial locations
• Build flexible protocols that reflect real-world nuclear medicine logistics
At Theragnostic Insights, we help sponsors bridge the gap between scientific ambition and operational reality. From strategic site selection to readiness assessments, we guide teams in building trials that are compliant and fully executable.
Radiopharmaceuticals have the potential to change the future of cancer care. But that future depends on whether today’s infrastructure can support tomorrow’s innovation.
Let’s get ready for it.
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] Xiong Y et al., 2024. A decade of incremental advances in radiopharmaceuticals. Journal of Translational Medicine.
[2] Pomykala KL et al., 2023. Tackling the Last Mile: Establishing Radioligand Therapy. Journal of Nuclear Medicine.
[3] BioPharma Dive, 2024. Radiopharmaceutical Trials: The Role of Site Selection and Support. BioPharma Dive.
[4] Lapi SE et al., 2024. Recent advances and impending challenges for the radiopharmaceutical sciences in oncology. The Lancet Oncology.
