Evidence map›Paper›PMID 36368481›Full record

ReviewContemporary clinical trials2022

Distribution of age, sex, race, and ethnicity in COVID-19 clinical drug trials in the United States: A review.

Daniel B Chastain, Vishwa S Patel, Alexandria M Jefferson, Sharmon P Osae, Joeanna S Chastain, Andrés F Henao-Martínez, Carlos Franco-Paredes, Henry N Young

Open access · greenAbstract readReview
In one paragraph

Review in Contemporary clinical trials, 2022. 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, top 84% 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

1 citing paper in PubMed, 0 citations in OpenAlex.

  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

8 authors at 4 institutions in 2 countries.

Daniel B ChastainUniversity of Georgia College of Pharmacy, Albany, GA 31701, USA. Electronic address: daniel.chastain@uga.edu.
Vishwa S PatelUniversity of Georgia, Athens, GA 30602, USA. Electronic address: Vishwa.Patel1@uga.edu.
Alexandria M JeffersonUniversity of Georgia, Athens, GA 30602, USA. Electronic address: Alexandria.Jefferson@uga.edu.
Sharmon P OsaeUniversity of Georgia College of Pharmacy, Albany, GA 31701, USA. Electronic address: Sharmon.osae@uga.edu.
Joeanna S ChastainPhoebe Putney Memorial Hospital, Albany, GA 31701, USA. Electronic address: jchastain@phoebehealth.com.
Andrés F Henao-MartínezDivision of Infectious Diseases, University of Colorado, Anschutz Medical Campus, Aurora, CO 80045, USA. Electronic address: andres.henaomartinez@cuanschutz.edu.
Carlos Franco-ParedesHospital Infantil de México, Federico Gómez, México City, Mexico. Electronic address: carlos.franco-paredes@cuanschutz.edu.
Henry N YoungUniversity of Georgia College of Pharmacy, Athens, GA 30602, USA. Electronic address: hnyoung@uga.edu.
University of Georgia · USHospital Infantil de México Federico Gómez · MXPhoebe Putney Memorial Hospital · USUniversity of Colorado Anschutz Medical Campus · US

Funding

Implementing a Maternal health and PRegnancy Outcomes Vision for Everyone (IMPROVE)UL1TR002378 · NCATS · EMORY UNIVERSITY · PI Andres J Garcia, Elizabeth O. Ofili · 2017 to 2026
$92.1M
NCATS NIH HHS UL1 TR002378
6 · The paper itself

Abstract

backgroundCOVID-19 quickly overwhelmed the world, but disproportionately affects certain communities, particularly minority groups. Despite overrepresentation among COVID-19 cases and death, minority groups were underrepresented in some of the early COVID-19 clinical trials.

objectiveTo assess and compare the demographic characteristics of COVID-19 clinical trial participants to national COVID-19 data.

methodsPubMed was searched from December 1, 2019 to November 24, 2020, for randomized controlled trials evaluating a pharmacologic treatment for COVID-19 patients from one or more U.S. sites written in the English language following the PRISMA checklist. Descriptive statistics were calculated to characterize patient demographics enrolled in the included clinical trials, as well as for comparison with national COVID-19 data.

resultsA total of 4472 records were identified, of which 16 studies were included. The median number of participants was higher in studies of nonhospitalized patients compared to those of hospitalized patients (n = 452 [range 20-1062] vs n = 243 [152-2795]). Ten (63%) studies reported mean or median ages of 50 years or older among all study arms. Males comprised more than half of the study cohort in ten (63%) studies. Race and ethnicity were reported separately in four (25%) studies but were combined when reported in five (31%) studies, while six (38%) reported only race or ethnicity. Proportional representation based on age, sex, race, and ethnicity was evident in some trials, but not in others, when compared to national data.

conclusionOverall, participants often did not reflect the actual population with COVID-19 and demographic characteristics were inconsistently reported.

Indexed as

COVID-19 Drug TreatmentCohort StudiesEthnicityFemaleHumansMaleMiddle AgedMinority GroupsUnited StatesCOVID-19Ethnic groupsHealth equityPatient selectionSARS-CoV-2

Identifiers

PMID36368481
PMCPMC9642036
OpenAlexW4308516680

What OpenQuestion holds

Textmetadata
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.