Evidence map›Paper›PMID 36931101›Full record

ArticleGynecologic oncology2023

What's in it for me?: A value assessment of gynecologic cancer clinical trials for Black women.

Ann Oluloro, Sarah M Temkin, Jonathan Jackson, Elizabeth M Swisher, Liz Sage, Kemi Doll

Abstract read
In one paragraph

Article in Gynecologic oncology, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing 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

2 citing papers in PubMed.

  1. Article
  2. 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.

Ann OluloroUniversity of Washington, 1959 Pacific Street, Box 356460, Seattle, WA 98195, USA. Electronic address: aoluloro@uw.edu.
Sarah M TemkinOffice of Research on Women's Health, 6707 Democracy Boulevard, Suite 400, Bethesda, MD 20817, USA.
Jonathan JacksonThe CARE Research Center, Massachusetts General Hospital, 50 Staniford Street, Suite 1082, Boston, MA 02114, USA.
Elizabeth M SwisherUniversity of Washington, 1959 Pacific Street, Box 356460, Seattle, WA 98195, USA.
Liz SageUniversity of Washington, 1959 Pacific Street, Box 356460, Seattle, WA 98195, USA.
Kemi DollUniversity of Washington, 1959 Pacific Street, Box 356460, Seattle, WA 98195, USA.

Funding

TRAINING IN CANCER BIOLOGY &TRANSPLANTATIONT32CA009515 · NCI · UNIVERSITY OF WASHINGTON · PI NANCY ELLEN DAVIDSON, Effie W Petersdorf · 1985 to 2026
$16.2M
Foundations of Representative Engagement, Valid & Effective Recruitment (FOREVER) in AD ResearchDP1AG069873 · NIA · MASSACHUSETTS GENERAL HOSPITAL · PI JACKSON, JONATHAN DAVID · 2020 to 2020
$3.3M
NCI NIH HHS T32 CA009515NIA NIH HHS DP1 AG069873
6 · The paper itself

Abstract

objectiveUnderrepresented groups may be dissuaded from clinical trial participation without perceived value. We therefore comprehensively assessed gynecologic cancer clinical trial protocols for the inclusion of items of value most important to Black individuals.

methodsClinicalTrials.gov was queried for NCI-sponsored gynecologic cancer clinical trials in the US between Jan.1994 and Nov.2021. Pre-specified return of value (ROV) items were abstracted from each protocol. Inclusion proportions were calculated for each ROV item and temporal changes assessed with chi-square tests. Temporality of proportional trends was further assessed by slope and departure from linearity calculations.

results279 gynecologic cancer clinical trials were included. Most commonly trials had first accrual in 2001-2007 (37%) and involved ovarian cancer (48%), phase II studies (53%), and chemotherapy (60%) or targeted therapy (34%). Trials often included ROV items in basic information (99%), medical record information (99%), and imaging (82%). 41% of trials included ROV items in biomarker testing, 20% genetic testing, and 20% in patient-reported outcome questionnaires. Over time, there were significant increases in the proportion of trials that included genetic (3% to 51%; p < 0.001) and biomarker testing (14 to 78%, p < 0.001). Information on lifestyle risk factors was rare (1%). No trials included ROV items in ancestry, how to connect with other participants, or remuneration.

conclusionsGynecologic cancer clinical trials include few design elements that provide high value to Black individuals like lifestyle risk factors, ancestry, and remuneration. In any multi-pronged effort to improve diversity in clinical trial enrollment, inclusion of items valued by Black individuals should be considered.

Indexed as

Genital Neoplasms, FemaleOvarian NeoplasmsPatient SelectionBlack or African AmericanClinical Trials as TopicFemaleHumansBlack womenCancer disparitiesClinical trialsGynecologic oncology

Identifiers

PMID36931101
PMCPMC10192016

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Registered trials

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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.