A conversation with START Dublin Director Dr. Austin Duffy reveals how a country that once had no Phase 1 oncology infrastructure should now be one of Europe’s go-to destinations for early-phase clinical trials.
Dr. Austin Duffy, Director of Clinical Research at START Dublin, still remembers the moment the case for early-phase oncology research in Ireland stopped being an abstract argument and became an urgent national conversation. It was the story of a prominent Irish patient advocate.
This patient advocate, who was living with cervical cancer, had initially responded well to first-line therapy. When it stopped working, she went looking for experimental options or early-phase studies but found none in all of Ireland. She ended up traveling to the National Institutes of Health (NIH) outside Washington, DC, to enroll in a trial, and then went on a nationally televised Irish talk show to describe the dilemma of choosing between time with her young family and access to potentially life-saving treatment thousands of miles away.
“Overnight, she was able to communicate that message more powerfully than I’d been trying to do for years,” Dr. Duffy recalls. He had spent more than a decade conducting early-phase research in the US, first at Memorial Sloan Ketting and then at the NIH, before returning to Ireland in 2017 and discovering a landscape almost devoid of Phase 1 oncology infrastructure. “Before START Dublin opened up as a site and started treating patients, there was actually no center in the whole country doing Phase 1 studies in oncology.”
The timing of this advocacy aligned with Dr. Duffy’s introduction to the START Center for Cancer Research. What followed has been a rapid and remarkable transformation, one that illustrates exactly what the Precision Site Network looks for in its member sites—proven performance, deep expertise, and a shared commitment to bringing novel therapies to patients who need them most.
Why Ireland Has Become a Strategic Location for Early-Phase Oncology Trials
When Dr. Duffy began building the case for START Dublin, the clinical trial landscape in Ireland was defined by a striking disconnect. The country had a strong tradition of clinical expertise, with Irish physicians who had returned home after training at world-class international institutions, and a well-established culture of clinical research. However, the healthcare system and infrastructure had not kept pace.
“Our patients’ time to access approved medicines was more delayed than the rest of Europe. In fact, it was twice the length of the European average,” Dr. Duffy explains. Even drugs with full European Medicines Agency (EMA) approval—therapies considered standard of care across most of the continent—were reaching Irish patients too late, if at all. For early-phase products, the picture was even bleaker as the clinical trials being conducted in Ireland were predominantly Phase 3, with almost no Phase 1 presence.
Dr. Duffy recognized that this disconnect and deficit, while devastating for patients, was the core of a powerful proposition for sponsors. With roughly 30,0000 new cancer patients each year and limited access to investigational therapies, Ireland represented enormous pent-up clinical demand and virtually no competition for enrollment. “It can become a huge advantage when you’re talking about accruing to clinical trials,” he says, “because it creates this huge sense of wanting to be involved, of wanting to get access to these medicines.”
The referral network was already in place, with approximately 80 oncologists spread across the country eager to send patients toward options that had not existed before. What was missing was the infrastructure and operational machinery to turn that demand into enrolled patients on study.
From No Phase 1 Infrastructure to a National Entry Point for Clinical Trials
START Dublin was established in October 2022 through a formal agreement between the START Network, the Mater Misericordiae University Hospital (Mater), and University College Dublin. One of Ireland’s premier general and cancer hospitals, Mater is the country’s trauma center, the national center for heart and lung transplants, and home to a medical oncology department that sees nearly 3,000 patients each year. It is also the busiest breast cancer site in Ireland and routes more than half of all patients in the country with gynecological cancers through its multidisciplinary team.
The building blocks for a high-performing Phase 1 program were in place, and START Dublin provided the operational framework to activate them.
The unit opened its doors with a purpose-built facility in October 2023, an event significant enough to be featured on Ireland’s main evening news broadcast. But the more meaningful milestone came two months later, on December 16, when the first patient was treated in a PfM study—a young women with microsatellite instability-high ovarian cancer who should have been receiving immunotherapy as SoC but could not access it through Ireland’s reimbursement system. The clinical trial granted her access.
“I think this story illustrates a number of points, most importantly the clinical need,” Dr. Duffy says. “This was really a way of giving Irish patients access to a drug they should have been getting anyway.”
Since that first treatment, the growth trajectory has been steep. In its first calendar year of operation, START Dublin treated 50 patients across Phase 1 studies, with enrollment numbers far exceeding that figure when factoring in pre-screening activity. The site currently has 10 clinical trials open and ongoing, with at least another nine expected to open in the next six months.
A Dedicated Trial Model That Improves Speed, Focus, and Data Quality
One of the attributes that sets START Dublin apart, and that resonates with what the Precision Site Network values in its member sites, is the fully dedicated nature of their team. Every member of the expanding START Dublin staff, now more than double the original seven, with plans to triple by the end of the year, works exclusively on START studies.
“They’re not off doing other clinics, they’re not off doing other studies,” Dr. Duffy emphasizes. “We’re all 100% working on START studies.” This is in stark contrast to the typical experience of an investigator running a clinical trial within the demands of a busy hospital practice, juggling research responsibilities alongside clinic patient duties and the constant triage of acute cancer care. “It’s very hard to focus on your research responsibilities when you’re doing all this day-to-day, really busy clinical oncology work,” Dr. Duffy says.
The downstream effects of this dedicated model touch every aspect of trial execution. Response times to sponsor queries, clinical research associate (CRA) communications, and data entry are all accelerated. “These soft knock-on effects are really tough to capture data-wise but really lead to very strong performance,” Dr. Duffy describes.
The team is organized across dedicated departments, including pharmacy, nursing, data management, pharmacokinetics, patient navigation, scheduling, and regulatory affairs, all supported by centralized START resources for budgeting, contracting, and legal matters. The infrastructure also integrates the technology platform that START brings to every site in its network, including an electronic health record (EHR) and clinical trial management system (CTMS). This last point is more significant than it might appear at first glance since, in Ireland’s broader hospital system, clinicians still work with paper charts. START Dublin operates on a fully electronic platform, aligned with every other site in the START network.
Faster Study Startup: How START Dublin Reduces Activation Timelines
For sponsors evaluating whether to include Ireland in a trial’s country footprint, the startup timeline is often a decisive factor. Dr. Duffy addresses this concern directly. “Our startup process is executed as a START process,” he explains. “It’s not a Mater Hospital Dublin process, it’s not an Irish process. So, we open studies just as quickly as they do in START Madrid, Barcelona, or Lisbon.”
The groundwork for this was laid during the two years between the 2022 partnership agreement and the first patient treatment. This period was spent pre-negotiating templates, aligning contract language, and ensuring that the hospital’s institutional review board (IRB) would function as a rapid sign-off rather than a bottleneck.
“You’re talking about a 24-hour turnaround,” Dr. Duffy says of the institutional review. “And it’s START that leads all of the negotiations with the sponsor or CRO.” This pattern of rapid activation and strong enrollment performance has been consistent across multiple studies.
Simplifying Clinical Trial Execution in Ireland: Single-Site Country Advantage
The pattern of START Dublin activating first, enrolling fast, and completing the national enrollment quota before other selected sites are operational has repeated across multiple studies. This track record forms the basis of a straightforward argument to sponsors that, in a country like Ireland, one site is all that is needed.
“Ireland is not a big country,” Dr. Duffy points out. “Even if you’re living at the other end of the country, it’s still just a couple of hours in the car.” Unlike the US, where patients may need to fly to reach a Phase 1 center, Irish geography makes a single national site eminently feasible.
Clinical Trial Capabilities Supporting Complex Early-Phase Oncology Studies
START Dublin’s capabilities extend beyond its core strengths in breast cancer, gynecological oncology, lung, prostate, and gastrointestinal (GI) malignancies. The site is equipped for intratumoral administration, oncolytic virus studies, drug-drug interaction (DDI) studies, and inpatient observation, including serial pharmacokinetic (PK) and cytokine release syndrome (CRS) monitoring for immunotherapy trials. A team of interventional radiologists, many trained at major US academic centers, supports biopsy collection and transarterial chemoembolization (TACE) procedures.
Radioligand therapy capability is actively in development. The hospital’s nuclear medicine team has already completed the regulatory and environmental groundwork required to administer agents such as Pluvicto through compassionate access programs. The institution also holds the necessary certifications for gene therapies and has a strong histopathology department capable of immunohistochemical (IHC) biomarker testing. In fact, the hospital is the national center for folate receptor testing.
At present, the primary limitation is cellular therapy, though a major grant between the hospital and university is funding the build-out of that capability over the next few years.
As a site still in the early phase of its own growth, START Dublin remains open to a broader range of study phases than some of the network’s more established sites. “We are more open to Phase 2 studies,” Dr. Duffy notes. “And because Irish patients really struggle to get standard of care treatments, we can also offer sponsors access to first-line patients or even adjuvant patients.” This flexibility makes the site a versatile option for sponsors conducting trials across the development continuum.
What Sponsors Gain from Working with START Dublin
What makes START Dublin a compelling addition to the Precision Site Network is not any single attribute in isolation. Instead, it is the convergence of factors that together exemplify a high-performing site:
- A large, underserved population with genuine clinical need
- A dedicated team that brings focus and responsiveness to every study
- Startup processes aligned with the fastest sites in the EU
- A principal investigator with international experience and enthusiasm for engaging directly with sponsors
- An institutional setting that provides the full infrastructure of a major academic medical center
These are the qualities that the Precision Site Network was built to identify and amplify. Every site in the over 100-site network is selected for proven performance, deep expertise, and a shared commitment to accelerating oncology and rare disease trials. START Dublin embodies this standard, delivering results that demonstrate what is possible when the right site, the right infrastructure, and the right partnerships come together in service of patients who have been waiting far too long.
“Our stress point is we can’t yet meet the demand of Irish patients,” Dr. Duffy says. “We need more studies.”
About START: A Global Leader in Early-Phase Oncology Trials
START represents the world's largest global network of fully dedicated, community-based, early-phase oncology clinical trial sites. With over 700 active early-phase trials and contributions to 45+ FDA/EMA-approved therapies, START is committed to its mission of "Hope Through Access"—bringing breakthrough cancer treatments to patients in their communities.
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