Evidence map›Paper›PMID 38605411›Full record

SynthesisTrials2024

How inclusive were UK-based randomised controlled trials of COVID-19 vaccines? A systematic review investigating enrolment of Black adults and adult ethnic minorities.

Hibba Herieka, Daphne Babalis, Evangelia Tzala, Shyam Budhathoki, Nicholas A Johnson

Open access · goldAbstract readSystematic Review
In one paragraph

Synthesis in Trials, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed
2.3field-weighted citation impact, top 12% 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

3 citing papers in PubMed, 6 citations in OpenAlex.

  1. Article
  2. Understanding Inclusion and Participation of People From Black African Diaspora Communities in Health and Care Research: A Realist Review.Health expectations : an international journal of public participation in health care and health policy · 2025
    Review
  3. 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

5 authors at 2 institutions in 1 country.

Hibba HeriekaUniversity of Leicester Medical School, University of Leicester, Leicester, UK.
Daphne BabalisImperial Clinical Trials Unit, School of Public Health, Faculty of Medicine, Imperial College London, Stadium House, 68 Wood Lane, London, W12 7RH, London, UK.
Evangelia TzalaSchool of Public Health, Faculty of Medicine, Imperial College London, London, UK.
Shyam BudhathokiSchool of Public Health, Faculty of Medicine, Imperial College London, London, UK.
Nicholas A JohnsonImperial Clinical Trials Unit, School of Public Health, Faculty of Medicine, Imperial College London, Stadium House, 68 Wood Lane, London, W12 7RH, London, UK. nicholas.johnson@imperial.ac.uk.ORCID http://orcid.org/0000-0002-3702-5530
Imperial College London · GBUniversity of Leicester · GB

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectivesTo establish if Black adults and adult ethnic minorities, defined as any group except White British, were represented in UK-based COVID-19 vaccination randomised controlled trials (RCTs) when compared to corresponding UK population proportions, based on 2011 census data.

designSystematic review of COVID-19 Randomised Controlled Vaccine Trials

settingUnited Kingdom

participantsRandomised Controlled Trials of COVID-19 vaccines conducted in the UK were systematically reviewed following PRISMA guidelines. MeSH terms included "Covid-19 vaccine", "Ad26COVS1", and "BNT162 Vaccine" with keywords such as [covishield OR coronavac OR Vaxzevria OR NVX-CoV2373] also used. Studies that provided (A) participant demographics and (B) full eligibility criteria were included. The following key data was extracted for analysis: number of participants analysed, number of Black adults and number of adult minority ethnicity participants. PRIMARY AND SECONDARY OUTCOME MEASURES: The primary outcome is the mean percentage of Black adults randomised to COVID-19 vaccine trials deemed eligible within this review. The secondary outcome is the mean percentage of adult ethnic minorities randomised.

resultsThe final review included 7 papers and a total of 87 sets of data collated from trial sites across the UK. The standard mean percentage of Black adults included in the trials (0.59%, 95% CI: 0.13% - 1.05%) was significantly lower compared to the recorded Black adult population (2.67%) indicating that they were under-served in UK based COVID-19 vaccine RCTs (p < 0.001). Adult ethnic minority presence (8.94%, 95% CI: 2.07% - 15.80%) was also lower than census data (16.30%), indicating they were also under-served (p = 0.039).

conclusionThe findings show that COVID-19 vaccine trials failed to adequately randomise proportionate numbers of Black adults and adult minority ethnicities. More inclusive practices must be developed and implemented in the recruitment of underserved groups to understand the true impact of COVID-19.

Indexed as

COVID-19COVID-19 VaccinesAdultBlack PeopleEthnic and Racial MinoritiesHumansRandomized Controlled Trials as TopicUnited KingdomCOVID-19 Vaccines

Identifiers

PMID38605411
PMCPMC11010339
OpenAlexW4394763060

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.