Approximately 390,000 Italians receive cancer diagnoses annually. A new early-phase clinical trial site in Rome is intended to give eligible patients another route to investigational treatment without separating trial evaluation from their existing oncology care.
The START Center for Cancer Research and Istituti Fisioterapici Ospitalieri announced the partnership on November 3, 2026. The site will operate within the Regina Elena National Cancer Institute and will be START’s first in Italy.
The opening expands trial options; it does not guarantee that a patient will qualify for a study or benefit from an experimental therapy.
An established institute, a new trial function
Regina Elena serves people from Rome and Lazio, along with referrals from elsewhere in Italy and abroad. The Italian Ministry of Health recognizes it as an IRCCS research hospital.
Its work combines diagnosis, treatment and research across rare cancers, hematological malignancies and major adult solid tumors. IFO also manages the San Gallicano Dermatological Institute.
START contributes its experience running early-phase oncology studies, while IFO brings clinical and translational research capabilities. The aim is to let patients, families and physicians consider research as one part of the continuum of care.
Livio De Angelis, IFO’s director general, described the intended connection between treatment and research.
“As a national cancer institute serving patients in Rome, Lazio, across Italy and internationally, we see this partnership as an opportunity to connect more patients with early-phase clinical research while strengthening the integration of care and innovation,” he said.
The gap the partners want to address
The diagnosis figure comes from the 2025 edition of “I numeri del cancro in Italia,” produced by AIOM and partner organizations. Despite that burden, Italy has fewer clinical trials relative to population than several other major Western European markets.
Nick Slack, START’s chairman and CEO, said the partnership would place research closer to Italian patients and provide sponsors with access through an established institution.
“By partnering with IFO and the Regina Elena National Cancer Institute, an established leader in Italian cancer care and research, we can bring early-phase oncology research closer to patients across Italy and advance our mission of providing Hope Through Access,” Slack said.
Giovanni Blandino, Regina Elena’s scientific director, pointed to the possible collaboration across numerous cancers.
“Combining Regina Elena’s multidisciplinary clinical and scientific expertise with START’s early-phase trial network can create new opportunities for collaboration and clinical research across a broad range of cancers,” he said.
Scale of the hospital and research network
Each year across its two institutes, IFO logs roughly 10,000 admissions for inpatient and day-hospital care and provides more than 1.275 million outpatient services. Regina Elena is part of Alleanza Contro il Cancro, which brings together Italian IRCCS cancer centers, and a European Reference Network focused on adult solid cancers.
The Rome unit will join START’s network from day one. START’s 17 locations span Europe and the United States, with more than 45 principal investigators and nearly 1,000 active industry-sponsored studies in its portfolio.
That portfolio offers options rather than assurances. Eligibility still depends on the particular trial and the patient’s circumstances, so patients should discuss any possible enrolment with their oncologist.
START’s record includes over 1,000 completed early-phase trials, with studies involving 50 therapies subsequently approved by the FDA or EMA.
Sources
- New START site at the IRCCS Istituto Nazionale Tumori Regina Elena will expand access to cancer clinical trials for patients in a major European oncology market
- Organisation of European Cancer Institutes
- START Expands its Global Early Phase Cancer Site Network into Italy Through Strategic Partnership with Istituti Fisioterapici Ospitalieri
Photo: Ashley Byrd / Unsplash (Unsplash License)
