Evidence map›Paper›PMID 40275255›Full record

ReviewBMC medical ethics2025

Diversity in decentralized clinical trials: prioritizing inclusion of underrepresented groups.

Tessa I van Rijssel, Johannes J M van Delden, Bart Lagerwaard, Mira G P Zuidgeest, Ghislaine J M W van Thiel, Trials@Home consortium

Abstract readReview
In one paragraph

Review in BMC medical ethics, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 5 papers.

0numbers the graph read from it
0cells of the map it votes in
5citing 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

5 citing papers in PubMed.

  1. Article
  2. Article
  3. Article
  4. Article
  5. 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

6 authors.

Tessa I van RijsselJulius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht, The Netherlands. t.i.vanrijssel@umcutrecht.nl.
Johannes J M van DeldenJulius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht, The Netherlands.
Bart LagerwaardJulius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht, The Netherlands.
Mira G P ZuidgeestJulius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht, The Netherlands.
Ghislaine J M W van ThielJulius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht, The Netherlands.
Trials@Home consortium

Funding

Innovative Medicines Initiative 831458
6 · The paper itself

Abstract

backgroundThe importance of more diversity of study populations in clinical trials is currently widely acknowledged. Decentralized clinical trial (DCT) approaches are presented as a potential means to broaden diversity by eliminating several barriers to participation. However, the precise meaning of, and objectives related to diversity in DCTs remain unclear. Diversity runs the risk of becoming a 'buzzword': widely acknowledged to be important, yet prone to multiple interpretations and challenging to implement in practice. We argue that the aim of increasing diversity in clinical trials requires clear and well-substantiated specifications.

methodsWe analyze the concept of diversity and the ethical requirements surrounding fair participant selection within the context of clinical research, in order to further specify and operationalize the aim of increasing diversity in the context of DCTs.

resultsThrough analyzing the concept of diversity and ethical requirements for fair participant selection, we propose that diversity should be specified in a way that improves the position of the groups that are currently most underrepresented in the research context. In practice, this entails that, in order to contribute to diversity, the selection of participants should prioritize (i) gaining scientific knowledge on groups for which this is lacking, and (ii) inclusion of underrepresented groups in research when appropriate considering a study's objectives, and risks and benefits.

conclusionsOur analysis facilitates translating the aim of increasing diversity with DCTs to more specific and actionable objectives for recruitment and inclusion. Moreover, it contributes to a further specification of the concept of diversity and fair participant selection in research contexts.

Indexed as

Biomedical ResearchClinical Trials as TopicCultural DiversityMinority GroupsPatient SelectionEthics, ResearchHumansResearch SubjectsDCTsDecentralized clinical trialsDiversityFair participant selectionResearch ethics

Identifiers

PMID40275255
PMCPMC12020247

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
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.