Evidence map›Paper›PMID 41798128›Full record

ReviewNeuro-oncology practice2026

Ethical considerations in randomization for neurosurgical oncology trials: A scoping review.

Nathan A Shlobin, Mira C Hasner, Philipp Karschnia, Georg Widhalm, George E D Petrescu, Philippe Schucht, Thiebaud Picart, Marian C Neidert, Jens Gempt, Rachel Grossman and 6 more

Abstract readReview
In one paragraph

Review in Neuro-oncology practice, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.

0numbers the graph read from it
0cells of the map it votes in
0citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

0 citing papers in PubMed.

No citing paper in PubMed yet.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

16 authors.

Nathan A ShlobinDepartment of Neurosurgery, Neurological Institute of New York, Columbia University Irving Medical Center, New York, New York, USA.ORCID https://orcid.org/0000-0003-2079-6125
Mira C HasnerDepartment of Cell and Chemical Biology, Leiden University Medical Center, Leiden, The Netherlands.
Philipp KarschniaDepartment of Neurosurgery, Ludwig-Maximilians-University School of Medicine, Munich, Germany.
Georg WidhalmDepartment of Neurosurgery, Medical University of Vienna, Austria.ORCID https://orcid.org/0000-0001-6014-0273
George E D PetrescuDepartment of Neurosurgery, Bagdasar-Arseni Clinical Emergency Hospital, Bucharest, Romania.
Philippe SchuchtDepartment of Neurosurgery, Bern University Hospital, University of Bern, Bern, Switzerland.
Thiebaud PicartDepartment of Neurosurgery, Hospices Civils of Lyon, Lyon, France.
Marian C NeidertDepartment of Neurosurgery, Cantonal Hospital St.Gallen, St. Gallen, Switzerland.
Jens GemptDepartment of Neurosurgery, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.ORCID https://orcid.org/0000-0003-4123-4690
Rachel GrossmanBrain Tumor Center, Department of Neurosurgery, Rambam Health Care Campus, Rappaport Faculty of Medicine, Technion - Israel Institute of Technology, Haifa, Israel.
Asgeir S JakolaDepartment of Neurosurgery, Sahlgrenska University Hospital, Gothenburg, Sweden.
Michael D JenkinsonDepartment of Neurosurgery, The Walton Centre NHS Foundation Trust, Liverpool, UK.
Roland GoldbrunnerCenter of Neurosurgery, Department of General Neurosurgery, University of Cologne, Cologne, Germany.
Michael WellerDepartment of Neurology, University Hospital and University of Zurich, Zurich, Switzerland.ORCID https://orcid.org/0000-0002-1748-174X
Johnny DuerinckDepartment of Neurosurgery, Universitair Ziekenhuis Brussel, Brussels, Belgium.ORCID https://orcid.org/0000-0001-9869-9806
Marike L D BroekmanDepartment of Neurosurgery, Haaglanden Medical Center, The Hague, The Netherlands.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Background: Increased interest in randomized controlled trials (RCTs) in neurosurgical oncology represents a significant advancement in the promotion of rigorous interventions in the field. However, the concept of randomization in neurosurgical oncology contains numerous ethical considerations. In this scoping review, we characterize the landscape of ethical challenges in randomization for neurosurgical oncology trials, highlight gaps in the literature, and delineate best practices for approaching randomization in these trials with a focus on the role of alternative study designs. Methods: A scoping review was conducted using the PubMed, Embase, and Scopus databases. Titles and abstracts were screened for relevance. Studies meeting prespecified inclusion criteria underwent full-text review. Relevant data were extracted. Results: Of 546 resultant articles, 20 were included. Seven (35%) studies focused on limitations of RCTs, 6 (30%) on utility of randomization, 4 (20%) on alternative designs, and 3 (15%) on informed consent. Randomization involves intrinsic ethical challenges in addition to practical challenges specific to neurosurgical oncology, including unrepresentative study populations, uncertainty regarding equipoise, and the inability to attain informed consent. Alternative study designs include preliminary prospective cohort studies with specific properties, on/off studies, seamless phase II/III trials, window-of-opportunity trials, and adaptive randomization models. Conclusions: Randomization in neurosurgical oncology RCTs is ethically challenging. RCTs are most useful when they significantly enhance the quality of evidence and have the potential to be practice-changing. When RCTs are the preferred study design, proper design and implementation may mitigate ethical challenges. In some cases, alternative study designs may advance research while safeguarding ethical priorities.

Indexed as

brain tumormedical ethicsneuro-oncologyneurosurgeryrandomization

Identifiers

PMID41798128
PMCPMC12965654

What Socratic holds

Textmetadata
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the Socratic graph.