Evidence map›Paper›PMID 40493876›Full record

ArticleJCO oncology practice2026

Representation of Women, Older Adults, and Racial and Ethnic Minoritized Patients in Pivotal Trials for US Food and Drug Administration Novel Oncology Therapeutic Approvals, 2012-2021: Bright Spot Trials and Trends Over Time.

Jennifer E Miller, William Pelletiers, Cary P Gross, Michelle Mello, Reshma Ramachandran, Jason L Schwartz, Sakinah Carter Suttiratana, Tanvee Varma, Joseph S Ross

Abstract read
In one paragraph

Article in JCO oncology practice, 2026. 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
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.

  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

9 authors.

Jennifer E MillerSection of General Internal Medicine, Yale School of Medicine, New Haven, CT.ORCID 0000-0002-3591-369X
William PelletiersSection of General Internal Medicine, Yale School of Medicine, New Haven, CT.
Cary P GrossSection of General Internal Medicine, Yale School of Medicine, New Haven, CT.
Michelle MelloStanford Law School, Department of Health Policy, Stanford University School of Medicine, Stanford, CA.ORCID 0000-0003-2877-4270
Reshma RamachandranSection of General Internal Medicine, Yale School of Medicine, New Haven, CT.ORCID 0000-0003-3845-3606
Jason L SchwartzDepartment of Health Policy and Management, Yale School of Public Health, New Haven, CT.
Sakinah Carter SuttiratanaEquity Research and Innovation Center, Yale School of Medicine, New Haven, CT.ORCID 0000-0001-9775-7736
Tanvee VarmaBrigham and Women's Hospital, Boston, MA.ORCID 0000-0002-8863-1485
Joseph S RossSection of General Internal Medicine, Yale School of Medicine, New Haven, CT.

Funding

FDA HHS U01 FD005938
6 · The paper itself

Abstract

purposeTo examine trends over time in clinical trial diversity for oncology therapeutics, identify bright spot trials adequately representing Black or Latino patients, and examine their associations with trial characteristics.

methodsThis retrospective cross-sectional study of trials supporting US Food and Drug Administration (FDA) oncology therapeutic approvals (2012-2021) compared proportions of enrolled women, older adults, and racial and ethnic minoritized patients with US patient populations with approved indications and US census data, exploring trends over time. We estimated the likelihood that an organization sponsoring a trial adequately representing Black patients also sponsored a trial adequately representing Latino patients, and vice versa, and examined associations of bright spot trials, trials adequately representing Black or Latino patients, with trial characteristics.

resultsThe FDA approved 111 oncology therapeutics (2012-2021) from 70 sponsors, on 121 trials enrolling 50,871 patients, of which 22,155 (44%) were women, 9,442 (19%) older adults (>64 years), 5,319 (9.6%) Asian, 1,353 (3%) Black, and 1,511 (3%) Latino. Zero trials adequately represented all patient demographics with no improvements for any group over the past 10 years (

conclusionDiverse trial enrollment is inadequate, without improvement over time. There are bright spot trials that may merit study for factors contributing to their successful recruitment of representative patients.

Indexed as

Clinical Trials as TopicNeoplasmsPatient SelectionAdultAgedCross-Sectional StudiesDrug ApprovalEthnicityFemaleHispanic or LatinoHumansMaleMiddle AgedRetrospective StudiesUnited StatesUnited States Food and Drug Administration

Identifiers

PMID40493876
PMCPMC12360498

What OpenQuestion holds

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LicenceCC BY-NC-ND
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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.