Evidence map›Paper›PMID 40293363›Full record

ArticleAJOB empirical bioethics

The Representative Studies Rubric: A Tool for Diversity in Clinical Trials.

Brian Minalga, Rona Siskind, Russell Campbell, Tyler Adamson, Mary Allegra Cermak, Annet Davis, Eddie D Givens, Molly Dyer, Katie McCarthy, Nicole A Montañez and 2 more

Abstract read
In one paragraph

Article in AJOB empirical bioethics. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.

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

0 citing papers in PubMed.

No citing paper in PubMed yet.

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

12 authors.

Brian MinalgaThe Legacy Project, Office of HIV/AIDS Network Coordination, Fred Hutchinson Cancer Center, Seattle, Washington, USA.ORCID 0000-0002-8447-390X
Rona SiskindAxle Informatics, Bethesda, Maryland, USA.
Russell CampbellThe Legacy Project, Office of HIV/AIDS Network Coordination, Fred Hutchinson Cancer Center, Seattle, Washington, USA.
Tyler AdamsonThe Legacy Project, Office of HIV/AIDS Network Coordination, Fred Hutchinson Cancer Center, Seattle, Washington, USA.
Mary Allegra CermakAdvancing Clinical Therapeutics Globally, Bethesda, Maryland, USA.
Annet DavisSchool of Nursing, University of Pennsylvania, Philadelphia, Pennsylvania, USA.
Eddie D GivensThe Legacy Project, Office of HIV/AIDS Network Coordination, Fred Hutchinson Cancer Center, Seattle, Washington, USA.
Molly DyerFHI 360, Durham, North Carolina, USA.
Katie McCarthyFHI 360, Durham, North Carolina, USA.
Nicole A MontañezFHI 360, Durham, North Carolina, USA.
Rhonda WhiteFHI 360, Durham, North Carolina, USA.
RSR Working Group

Funding

LOC: HIV Vaccine Trials NetworkUM1AI068614 · NIAID · FRED HUTCHINSON CANCER RESEARCH CENTER · PI Dan H. Barouch, Lawrence Corey · 2011 to 2026
$1175.6M
LOC-IMPAACT Leadership GroupPharmacokinetics and Safety of Remdesivir for Treatment of COVID-19 in Pregnant Women in the USUM1AI068632 · NIAID · SOCIAL AND SCIENTIFIC SYSTEMS, INC. · PI Jennifer Jao, Sharon A Nachman · 2011 to 2026
$278.1M
NIAID NIH HHS UM1 AI068614NIAID NIH HHS UM1 AI068632
6 · The paper itself

Abstract

When clinical trials fail to enroll diverse study populations, a multitude of consequences can occur, including compromised validity and generalizability, safety and efficacy uncertainties, regulatory limitations, widened disparities, distrust in science and medicine, and undermined efforts to address urgent health needs. We developed the Representative Studies Rubric (RSR), a questionnaire that evaluates the extent to which clinical trials are designed to enroll representative study populations with a focus on age, ethnicity, drug use, gender, pregnancy, race, and sex assigned at birth. We used the RSR to conduct an analysis of all active studies in the NIH-funded HIV/AIDS Clinical Trials Networks (Networks) and identified patterns of research practices that may limit the participation of underrepresented populations, with ethical implications. The Networks subsequently formalized the RSR as a required protocol development tool for all future studies to correct exclusionary research practices with the goal to achieve more representative study populations.

Indexed as

Clinical Trials as TopicCultural DiversityPatient SelectionResearch DesignEthnicityFemaleHIV InfectionsHumansMaleNational Institutes of Health (U.S.)PregnancySurveys and QuestionnairesUnited StatesBioethicsempirical researchhealth policypolicy analysispublic healthsocial science

Identifiers

PMID40293363
PMCPMC12353466

What OpenQuestion holds

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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.