Evidence map›Paper›PMID 42780995›Full record

SynthesisFrontiers in medicine2026

Race and trial region changes in cancer clinical trials between 2013 and 2024.

Satoshi Hirano, Keisuke Hanada, Hideki Maeda

Abstract readSystematic Review
In one paragraph

Synthesis in Frontiers in medicine, 2026. 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

3 authors.

Satoshi HiranoRegulatory Science, Graduate School of Pharmaceutical Science, Meiji Pharmaceutical University, Tokyo, Japan.
Keisuke HanadaDepartment of Biostatistics, Faculty of Medicine, Wakayama Medical University, Wakayama, Japan.
Hideki MaedaRegulatory Science, Graduate School of Pharmaceutical Science, Meiji Pharmaceutical University, Tokyo, Japan.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Background: The latest changes in racial and geographical enrollment in cancer clinical trials in the 2020s have not been fully characterized, despite ongoing measures by the US Food and Drug Administration (FDA) to enhance diversity. We aimed to quantitatively elucidate the trial population of FDA-approved cancer drugs by race and trial region in 2013-2024. Methods: FDA drug approvals granted from January 2013 through December 2024 were reviewed by the FDA Oncology (Cancer)/Hematologic Malignancies Approval Notifications and FDA Application Review Files. Of 515 approval notifications screened, 92 eligible ones were analyzed. The primary endpoint was the ratio of each race and trial region among the datasets submitted for FDA approval. Results: Our analysis included 23,539 participants. Although the majority race has remained White, the proportion of White decreased from 83.2% in 2013-2016 to 68.9% in 2021-2024. The proportion of Asians and Asian trial region increased from 9.3% and 7.4% in 2013-2016 to 21.4% (95% CI, 20.53-22.35) and 19.7% (95% CI, 18.81-20.57) in 2021-2024, respectively. The proportion of Black people remained under 4%. Conclusion: From 2013 to 2016 to 2021-2024, Black people underrepresentation has persisted, whereas the enrollment of Asians at race level and participants from Asia at region level have increased.

Indexed as

clinical trialenrollmentoncologyracetrial region

Identifiers

PMID42780995
PMCPMC13598081

What OpenQuestion holds

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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.