Evidence map›Paper›PMID 40152249›Full record

ArticleJNCI cancer spectrum2025

Evaluating patient diversity in early phase clinical trials in Australia through a prospective multicenter nonrandomized cohort study.

Udit Nindra, Joanne Tang, Jun Hee Hong, Martin Hong, Christina Teng, Joe Wei, Andrew Killen, Adam Cooper, Kate Wilkinson, Weng Ng and 3 more

Abstract readMulticenter Study
In one paragraph

Article in JNCI cancer spectrum, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing 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

2 citing papers in PubMed.

  1. Network-Integrated Platform for Clinical Trial Navigation from the New South Wales Early Phase Clinical Trials Alliance.Clinical cancer research : an official journal of the American Association for Cancer Research · 2026
    Article
  2. Inequities in enrollment across clinical trial phases and the need for a Spanish perspective.Clinical & translational oncology : official publication of the Federation of Spanish Oncology Societies and of the National Cancer Institute of Mexico · 2026
    Review
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

13 authors.

Udit NindraDepartment of Medicine, Western Sydney University, Campbelltown, Australia.ORCID 0000-0002-2612-9502
Joanne TangDepartment of Medical Oncology, Liverpool Hospital, Liverpool, Australia.ORCID 0009-0002-7530-9953
Jun Hee HongDepartment of Medical Oncology, Liverpool Hospital, Liverpool, Australia.ORCID 0000-0002-9977-7471
Martin HongDepartment of Medical Oncology, Liverpool Hospital, Liverpool, Australia.ORCID 0000-0002-2327-4261
Christina TengScientia Clinical Research, Randwick, Australia.ORCID 0000-0002-3716-8611
Joe WeiScientia Clinical Research, Randwick, Australia.ORCID 0000-0003-1944-1079
Andrew KillenScientia Clinical Research, Randwick, Australia.
Adam CooperDepartment of Medical Oncology, Liverpool Hospital, Liverpool, Australia.
Kate WilkinsonDepartment of Medical Oncology, Liverpool Hospital, Liverpool, Australia.
Weng NgDepartment of Medicine, Western Sydney University, Campbelltown, Australia.ORCID 0000-0003-2354-1857
Charlotte LemechScientia Clinical Research, Randwick, Australia.ORCID 0000-0002-5399-9431
Wei ChuaDepartment of Medicine, Western Sydney University, Campbelltown, Australia.
Abhijit PalDepartment of Medical Oncology, Liverpool Hospital, Liverpool, Australia.ORCID 0000-0002-4600-6569

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundEarly phase clinical trials continue to have difficulty with enrolling real-world populations with many minorities being underrepresented. Reasons for this include patient or clinician perception as well as cultural, linguistic, or social barriers. In Australia, there is currently no prospective data in the early phase clinical trial space regarding recruitment of priority populations.

methodsPatient Diversity in Early Phase Clinical Trials was a multicenter, prospective, cohort study involving 2 major early phase clinical trial centers in Sydney, Australia. All participants who were consented to an early phase clinical trial between August 2023 and August 2024 were enrolled. Participants completed a baseline demographic survey, which included cultural and linguistic status, sexual orientation, socioeconomic status, and regional diversity.

resultsA total of 114 participants were recruited. Median age was 63 years (range = 25-83 years) with predominance for female participants (52%). No participant reported a nonbinary gender. All participants reported their sexuality as heterosexual, with no LGBTQIA+ participants recruited. A total of 34 (30%) participants were identified as culturally diverse, while 28 (25%) were linguistically diverse. One patient identified as Indigenous Australian. Of the participants, 26% were born overseas, with 44% having at least 1 parent born overseas. The majority were living in households with family members, with 8% of participants living alone.

conclusionPatient Diversity in Early Phase Clinical Trials is the first prospective study that provides granular description of social, cultural, linguistic, economic, and sexual diversity among early phase clinical trial participants. Certain subgroups are underrepresented, including those with sexual diversity, gender diversity, and Indigenous backgrounds. Ongoing efforts to monitor and promote inclusion of diverse populations in clinical trials are vital.

Indexed as

Clinical Trials as TopicCultural DiversityPatient SelectionAdultAgedAged, 80 and overAustraliaFemaleHumansMaleMiddle AgedProspective StudiesSocial Class

Identifiers

PMID40152249
PMCPMC12020725

What OpenQuestion holds

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LicenceCC BY
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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 OpenQuestion graph.