Speed as Strategy: How Site Scarcity Is Slowing Radiopharmaceutical Pipelines

The Risk of Moving Too Slowly

Radiopharmaceuticals are transforming the oncology landscape, offering new ways to detect and treat cancer. But even as scientific breakthroughs accelerate, many programs are slowing down, not because of the science, but because of a lack of ready clinical sites.

Radioligand therapy (RLT) trials are built on a strong oncology backbone, but they require an additional layer of expertise. Beyond standard oncology trial capabilities, sites must support advanced imaging, radiation safety protocols, nuclear medicine workflows, and specialized radiopharmacy coordination. This added complexity makes it harder to find sites that are truly prepared to run these studies. And when sites are not fully equipped for that expanded scope, trials do not start and pipelines stall.

A 2024 review from Wellcome Open Research found that when study protocols are more complex than what a site can handle, it often leads to trial delays and execution problems [1]. In radiopharma, these delays can affect program value, investor interest, and even regulatory timing. And while scientific momentum might drive asset excitement, operational drag can quietly erode a program’s trajectory.

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The Supply Problem: Not Enough Sites, Not Enough Time

More radiopharmaceutical trials are launching every year. But the number of sites that can actually run these trials isn’t growing fast enough. A 2023 MDPI report found that most nuclear medicine centers are not set up to meet the strict standards required for clinical trials [2].

Some sites have the right equipment, like PET or SPECT scanners. But they may not have trained staff, reliable scheduling systems, or safe storage for radioactive materials. Others might look qualified on paper, but struggle with internal coordination or handling isotopes like lutetium-177 or actinium-225 safely.

That gap creates real problems. A 2023 study in the Journal of Clinical and Translational Science proposed a detailed checklist to evaluate whether a site is truly ready. It stressed that readiness includes more than interest, it’s about staff, equipment, workflows, and prior experience with radiopharmaceutical trials [3].

For RLT trials, timing is everything. Missed imaging windows or scheduling delays can lead to protocol issues, safety risks, or data quality concerns. That means sponsors can’t afford to assume a site is ready, they have to know. Lack of coordination between nuclear medicine, radiopharmacy, and oncology teams can create cascading delays that are difficult to recover from mid-study.

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Why Trial Delays Hurt More in Radiopharma

All trials are expensive. But delays in radiopharmaceutical programs come with extra costs. These are early-phase programs with limited funding and ambitious timelines. A 2023 article from the Journal of the Association of Community Cancer Centers (ACCC) made the case that infrastructure and operational planning should be part of a sponsor’s financial strategy in addition to logistics planning [4].

Every month of delay reduces time on market, increases cash burn, and complicates planning for future phases or partnerships. It can also disrupt timelines for imaging agents, companion diagnostics, or manufacturing scale-up.

And most importantly, delays impact patients. These are often late-stage cancer patients waiting on better treatment options. Slower trial activation means slower access. For time-sensitive oncology indications, that gap can mean the difference between viable treatment options and missed windows of opportunity.

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How to Move Faster, Starting Now

Investors are increasingly recognizing that trial site infrastructure is not just a cost center. It is a source of R&D efficiency and value protection. A 2023 ACCC paper emphasized the importance of early site capability assessments and infrastructure planning to accelerate oncology trial readiness [5]. The paper also notes that community sites are often overlooked despite their potential to increase geographic access and enrollment equity if adequately supported.

Readiness investments at the site level reduce the likelihood of mid-trial amendments, regulatory issues, and protocol deviations, all of which carry real financial implications. With more radiotherapeutics entering Phase I and II studies, infrastructure strategy is becoming a defining variable in asset valuation and partner confidence.

Infrastructure also influences clinical credibility. When sites demonstrate reliability in scheduling, workflow coordination, and patient throughput, sponsors gain confidence not only in the science but in the path to approval. This perceived reliability is critical during licensing discussions and investor evaluations, where predictability can influence both milestone funding and valuation models.

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What Sponsors Should Do Now

Sponsors can take a few clear steps to get ahead of site shortages:

• Start Early - Begin looking for sites during protocol development. The sooner gaps are found, the sooner they can be fixed.
• Use Real Readiness Tools - Go beyond general interest. Ask specific questions about workflows, prior experience with agents like lutetium-177, and cross-department coordination.
• Look Beyond the Obvious - Academic centers are important, but don’t overlook regional or community hospitals. With the right support, many can run radiopharma trials well.
• Design with Feasibility in Mind - Match the protocol to what sites can actually do. Complex designs are fine—but only if sites are equipped to deliver

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Theragnostic Insight - Clinical speed starts at the site.

At Theragnostic Insights, we help sponsors match clinical designs with real-world operational readiness. From assessing infrastructure to planning activation, we focus on keeping your programs moving because in radiopharma, timelines matter.

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‍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

7.     Speed as Strategy: How Site Scarcity Is Slowing Radiopharmaceutical Pipelines

8.     One Roof, Many Bottlenecks: Why Fragmented Site Models Undermine RLT Trials

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References:

[1] Hill S et al., 2024. Infrastructure, Capabilities, and Capacities Required for Clinical Trials Design and Delivery: A Rapid Scoping Review. Wellcome Open Research

[2] Duncan GM et al., 2024. How to Design and Construct a Radiochemistry/Radiopharmacy Facility. MDPI

[3] Pinto HA et al., 2023. A Framework for Assessing Clinical Trial Site Readiness. Journal of Clinical and Translational Science

[4] Valentino M et al., 2023. From Readiness to Research: Building Clinical Trial Capacity at Community Cancer Centers. Journal of the Association of Community Cancer Centers

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