What Israeli Centres Add to Global Oncology Trials

An oncology site's contribution begins well before the first patient is enrolled. Investigators help clarify where a study fits in the treatment pathway, which biological questions can be explored and whether the required assessments are workable in clinical practice. These contributions become particularly valuable when development programmes involve molecular selection, several specialties or narrowly defined treatment histories.

Published research involving Israeli investigators offers concrete examples. Precision oncology, international urothelial cancer trials and population-based lung cancer research reveal different strengths that can inform multinational study planning. The useful question is how those capabilities fit a particular protocol.

Connecting molecular information with clinical decisions

The international WINTHER trial explored treatment selection using tumour DNA profiling or RNA expression analysis comparing tumour and matched normal tissue. Its investigators included Raanan Berger, Aliza Ackerstein and Amir Onn from Sheba Medical Center, alongside colleagues from centres in Europe and North America. 1

Among 303 patients who consented, 107 were evaluable for therapy. The study did not meet its prespecified primary endpoint. Nevertheless, its prospective design demonstrated an international approach to integrating molecular analysis with treatment recommendations for patients with advanced cancers. 1

For sponsors, this experience suggests a valuable line of feasibility enquiry: can a centre connect the required tissue collection, laboratory workflow and clinical decision within the patient's available treatment window?

The practical contribution of a molecularly experienced investigator includes recognising where that pathway may break down. A biopsy may be technically possible while its timing, tissue yield or reporting process makes it unsuitable for a particular study. Discussing those constraints early can improve site selection and screening plans.

Bringing disease-specific experience to complex pathways

Israeli investigators have also contributed to large international trials in urothelial cancer. Avivit Peer of Rambam Health Care Campus was a coauthor of the primary CheckMate 274 publication, which evaluated adjuvant nivolumab against placebo following radical surgery for high-risk muscle-invasive urothelial carcinoma. The trial reported longer disease-free survival with nivolumab in the overall randomised population. 2

That contribution places Israeli expertise within an international evidence base spanning surgery, pathology and systemic treatment. It also illustrates why matching a centre to a disease label is only the beginning.

For a study conducted after surgery, feasibility discussions should examine referral from surgical teams, availability of pathology information, recovery and the protocol's treatment window. For another urothelial protocol, the relevant questions may concern prior systemic therapies, tissue requirements or coordination of different treatment modalities.

The publication establishes participation in that research programme. Current staffing, competing trials and eligible patient flow still require a fresh assessment. Disease-specific experience makes that discussion more informed and productive.

Learning from the treatment pathway outside a trial

LUMINATE-101-Maccabi provides a complementary perspective. Sarah Sharman Moser, Alona Zer, Jair Bar and colleagues used de-identified Maccabi Healthcare Services data to examine treatment patterns and outcomes in metastatic, non-squamous non-small-cell lung cancer without actionable genetic alterations. The retrospective cohort covered patients receiving second or later treatment lines during 2017-2020. 3

Among 176 patients, 30.7% received third-line therapy. This finding highlights a planning issue: the population diagnosed with a cancer can be substantially larger than the population that reaches a later treatment line. The historical treatment sequences also differ from many contemporary pathways, limiting direct extrapolation to current recruitment. 3

For a new study, this type of research helps formulate better questions. How many patients receive the required previous regimen? How quickly do they move to another treatment? At what point are molecular results, performance status and referral information available?

Population data can inform those questions, subject to appropriate access and governance. Investigators then help test whether the historical picture reflects today's patients and the protocol's precise requirements.

Figure 1. Three complementary contributions illustrated by published research involving Israeli investigators. These examples inform protocol-specific assessment; they do not establish current site availability or predict recruitment. Original conceptual illustration based on references 1-3.

Turning published expertise into a country case

Together, these examples support a practical approach to evaluating Israeli centres. Begin with the scientific and clinical demands of the study, then identify investigators whose published work and current practice address those demands.

A focused assessment with two or three potential centres can examine the eligible population, sample requirements, referral arrangements and delivery capacity. Where appropriate, investigator feedback may also identify useful translational questions or clarify how study procedures interact with routine care.

This approach is consistent with ICH E6(R3)'s emphasis on building quality into trial design and using proportionate, workable processes. Published expertise becomes most useful when translated into specific responsibilities and a realistic delivery plan. 4

Israel's contribution to an international oncology programme can therefore extend across biological interpretation, disease-specific clinical judgement and understanding of patient pathways. A strong country case connects those capabilities to a defined research question, with evidence for what the selected centres can contribute now.

References

1. Rodon J, Soria JC, Berger R, et al. Genomic and transcriptomic profiling expands precision cancer medicine: the WINTHER trial. Nature Medicine. 2019;25:751-758. Read the publication.

2. Bajorin DF, Witjes JA, Gschwend JE, et al. Adjuvant nivolumab versus placebo in muscle-invasive urothelial carcinoma. New England Journal of Medicine. 2021;384:2102-2114. Read the publication.

3. Sharman Moser S, Zer A, Hejazi A, et al. LUMINATE-101-Maccabi: a real-world study of treatment patterns and clinical outcomes in patients with non-squamous metastatic non-small cell lung cancer in an Israeli Health Maintenance Organization (HMO). Expert Review of Anticancer Therapy. 2026. Read the publication.

4. US Food and Drug Administration / International Council for Harmonisation. E6(R3) Good Clinical Practice. Final FDA guidance. September 2025. Read the guidance.