Evidence map›Paper›PMID 38508621›Full record

ArticleBMJ open2024

Exploring the barriers to, and importance of, participant diversity in early-phase clinical trials: an interview-based qualitative study of professionals and patient and public representatives.

Robin Chatters, Munyaradzi Dimairo, Cindy Cooper, Shamila Ditta, Jonathan Woodward, Katie Biggs, Della Ogunleye, Fiona Thistlethwaite, Christina Yap, Alexander Rothman

Open access · goldAbstract read
In one paragraph

Article in BMJ open, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 11 papers.

0numbers the graph read from it
0cells of the map it votes in
11citing papers in PubMed
9.2field-weighted citation impact, top 2% of its field
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

11 citing papers in PubMed, 17 citations in OpenAlex.

  1. 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
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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

10 authors at 4 institutions in 1 country.

Robin ChattersSheffield Clinical Trials Research Unit (CTRU), Sheffield Centre for Health and Related Research, The University of Sheffield, Sheffield, UK r.chatters@sheffield.ac.uk.ORCID 0000-0002-1945-6011
Munyaradzi DimairoSheffield Clinical Trials Research Unit (CTRU), Sheffield Centre for Health and Related Research, The University of Sheffield, Sheffield, UK.
Cindy CooperSheffield Clinical Trials Research Unit (CTRU), Sheffield Centre for Health and Related Research, The University of Sheffield, Sheffield, UK.
Shamila DittaSheffield Clinical Trials Research Unit (CTRU), Sheffield Centre for Health and Related Research, The University of Sheffield, Sheffield, UK.
Jonathan WoodwardSheffield Clinical Trials Research Unit (CTRU), Sheffield Centre for Health and Related Research, The University of Sheffield, Sheffield, UK.
Katie BiggsSheffield Clinical Trials Research Unit (CTRU), Sheffield Centre for Health and Related Research, The University of Sheffield, Sheffield, UK.ORCID 0000-0003-4468-7417
Della OgunleyePatient representative, London, UK.
Fiona ThistlethwaiteThe Christie Hospital NHS Foundation Trust and University of Manchester, Manchester, UK.
Christina YapClinical Trials and Statistics Unit, The Institute of Cancer Research, Sutton, UK.ORCID 0000-0002-6715-2514
Alexander RothmanDepartment of Infection, Immunity, and Cardiovascular Disease, The University of Sheffield and Sheffield Teaching Hospitals NHS Foundation Trust, Sheffield, UK.
University of Sheffield · GBInstitute of Cancer Research · GBSheffield Teaching Hospitals NHS Foundation Trust · GBThe Christie Hospital · GB

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectivesTo explore the importance of, and barriers to achieving, diversity in early-phase clinical trials.

designQualitative interviews analysed using thematic analysis. SETTING AND

participantsFive professionals (clinical researchers and methodologists) and three patient and public representatives (those with experience of early-phase clinical trials and/or those from ethnic minority backgrounds) were interviewed between June and August 2022. Participants were identified via their institutional web page, existing contacts or social media (eg, X, formerly known as Twitter).

resultsProfessionals viewed that diversity is not currently considered in all early-phase clinical trials but felt that it should always be taken into account. Such trials are primarily undertaken at a small number of centres, thus limiting the populations they can access. Referrals from clinicians based in the community may increase diversity; however, those referred are often not from underserved groups. Referrals may be hindered by the extra resources required to approach and recruit underserved groups and participants often having to undertake 'self-driven' referrals. Patient and public representatives stated that diversity is important in research staff and that potential participants should be informed of the need for diversity. Those from underserved groups may require clarification regarding the potential harms of a treatment, even if these are unknown. Education may improve awareness and perception of early-phase clinical trials. We provide 14 recommendations to improve diversity in early-phase clinical trials.

conclusionsDiversity should be considered in all early-phase trials. Consideration is required regarding the extent of diversity and how it is addressed. The increased resources needed to recruit those from underserved groups may warrant funders to increase the funds to support the recruitment of such participants. The potential harms and societal benefits of the research should be presented to potential participants in a balanced but accurate way to increase transparency.

Indexed as

EthnicitySocial MediaEducational StatusHumansMinority GroupsQualitative ResearchClinical trialsHealth EquityQUALITATIVE RESEARCH

Identifiers

PMID38508621
PMCPMC10952868
OpenAlexW4393011567

What OpenQuestion holds

Textmetadata
LicenceCC BY
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 OpenQuestion graph.