Evidence map›Paper›PMID 41508127›Full record

ArticleTrials2026

Reviewing inclusivity of the UK bladder and head and neck oncology trial portfolio through eligibility criteria: a scoping review.

Georgiana Synesi, Rebecca Lewis, Lucy Kilburn, Judith Bliss, Ka Ching Cheung, Hannah Gribble, Karen Poole, Morgaine Stiles, Emma Hall

Abstract readScoping Review
In one paragraph

Article in Trials, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing 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

1 citing paper in PubMed.

  1. Article
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

9 authors.

Georgiana SynesiClinical Trials and Statistics Unit, The Institute of Cancer Research, London, SM2 5GP, UK. Georgiana.Synesi@icr.ac.uk.ORCID http://orcid.org/0000-0001-7220-6604
Rebecca LewisClinical Trials and Statistics Unit, The Institute of Cancer Research, London, SM2 5GP, UK.
Lucy KilburnClinical Trials and Statistics Unit, The Institute of Cancer Research, London, SM2 5GP, UK.
Judith BlissClinical Trials and Statistics Unit, The Institute of Cancer Research, London, SM2 5GP, UK.
Ka Ching CheungClinical Trials and Statistics Unit, The Institute of Cancer Research, London, SM2 5GP, UK.
Hannah GribbleClinical Trials and Statistics Unit, The Institute of Cancer Research, London, SM2 5GP, UK.
Karen PooleClinical Trials and Statistics Unit, The Institute of Cancer Research, London, SM2 5GP, UK.
Morgaine StilesClinical Trials and Statistics Unit, The Institute of Cancer Research, London, SM2 5GP, UK.
Emma HallClinical Trials and Statistics Unit, The Institute of Cancer Research, London, SM2 5GP, UK.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundIn clinical trials, eligibility criteria define a population who may benefit from the intervention without incurring undue safety risks. Despite their value, overly stringent eligibility criteria may pose barriers to inclusive recruitment. They may disproportionately exclude groups of people more likely to be diagnosed at later cancer stages, or have specific co-morbidities which can be associated with socio-demographic or ethnic background. The National Institute for Health and Care Research Innovations in Clinical Trial Design and Delivery for the Under-served (NIHR-INCLUDE) guidance highlighted several groups of people who may be underserved by clinical research. The aim of this review was to assess eligibility criteria in bladder and head and neck oncology trials and consider their potential impact on potentially underserved groups.

methodsThis scoping review included multi-centre, interventional, phase II and III trials in bladder or head and neck cancer, which recruited UK participants between 2013 and 2023. Trials were identified via searches of ClinicalTrials.gov, the International Standard Randomised Controlled Trial Number (ISRCTN) registry, and NIHR Clinical Portfolio Management System (CPMS). Trials' eligibility criteria were categorised and analysed narratively. Trial parameters (recruitment period, funding type, and whether they were of investigational medicinal products (IMPs)) were cross-tabulated with common exclusion criteria using Fisher's exact test.

resultsThirty-eight bladder and 30 head and neck cancer trials met the selection criteria. Twenty-eight out of 68 (41%) had non-commercial sponsors. Fifty-six out of 68 (82%) were of IMPs. Forty-one out of 68 (60%) were industry-funded. Fifty-one out of 68 (75%) were for locally advanced, metastatic, or recurrent disease. Common exclusion criteria relating to pregnancy, performance status, HIV status, and cognitive ability may disproportionately impact some underserved groups suggested by the NIHR-INCLUDE guidance.

conclusionsThis review highlights common exclusion criteria which may disproportionately exclude underserved groups from UK bladder and head and neck oncology trials. To facilitate accessibility to oncology trials, sponsors and triallists should consider how potentially underrepresented groups may be safely included during development of eligibility criteria.

Indexed as

Clinical Trials as TopicEligibility DeterminationHead and Neck NeoplasmsPatient SelectionUrinary Bladder NeoplasmsHumansMulticenter Studies as TopicUnited KingdomDiversityEligibility criteriaEqualityInclusivityOncology clinical trials

Identifiers

PMID41508127
PMCPMC12790708

What OpenQuestion holds

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LicenceCC BY
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Registered trials

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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 OpenQuestion graph.