CoChat
Sign Up
Cited by 2,078Ethics in Clinical ResearchGlobal Cancer Incidence and ScreeningStatistical Methods in Clinical Trials

Participation in Cancer Clinical Trials: Race-, Sex-, and Age-Based Disparities

Murthy, Vivek H., Krumholz, Harlan M., Gross, Cary P.·2004·JAMA
DOI 10.1001/jama.291.22.2720
Open this paper in CoChat — free account

Abstract

CONTEXT: Despite the importance of diversity of cancer trial participants with regard to race, ethnicity, age, and sex, there is little recent information about the representation of these groups in clinical trials. OBJECTIVE: To characterize the representation of racial and ethnic minorities, the elderly, and women in cancer trials sponsored by the National Cancer Institute. DESIGN, SETTING, AND PATIENTS: Cross-sectional population-based analysis of all participants in therapeutic nonsurgical National Cancer Institute Clinical Trial Cooperative Group breast, colorectal, lung, and prostate cancer clinical trials in 2000 through 2002. In a separate analysis, the ethnic distribution of patients enrolled in 2000 through 2002 was compared with those enrolled in 1996 through 1998, using logistic regression models to estimate the relative risk ratio of enrollment for racial and ethnic minorities to that of white patients during these time periods. MAIN OUTCOME MEASURE: Enrollment fraction, defined as the number of trial enrollees divided by the estimated US cancer cases in each race and age subgroup. RESULTS: Cancer research participation varied significantly across racial/ethnic and age groups. Compared with a 1.8% enrollment fraction among white patients, lower enrollment fractions were noted in Hispanic (1.3%; odds ratio [OR] vs whites, 0.72; 95% confidence interval [CI], 0.68-0.77; P<.001) and black (1.3%; OR, 0.71; 95% CI, 0.68-0.74; P<.001) patients. There was a strong relationship between age and enrollment fraction, with trial participants 30 to 64 years of age representing 3.0% of incident cancer patients in that age group, in comparison to 1.3% of 65- to 74-year-old patients and 0.5% of patients 75 years of age and older. This inverse relationship between age and trial enrollment fraction was consistent across racial and ethnic groups. Although the total number of trial participants increased during our study period, the representation of racial and ethnic minorities decreased. In comparison to whites, after adjusting for age, cancer type, and sex, patients enrolled in 2000 through 2002 were 24% less likely to be black (adjusted relative risk ratio, 0.76; 95% CI, 0.65-0.89; P<.001). Men were more likely than women to enroll in colorectal cancer trials (enrollment fractions: 2.1% vs 1.6%, respectively; OR, 1.30; 95% CI, 1.24-1.35; P<.001) and lung cancer trials (enrollment fractions: 0.9% vs 0.7%, respectively; OR, 1.23; 95% CI, 1.16-1.31; P<.001). CONCLUSIONS: Enrollment in cancer trials is low for all patient groups. Racial and ethnic minorities, women, and the elderly were less likely to enroll in cooperative group cancer trials than were whites, men, and younger patients, respectively. The proportion of trial participants who are black has declined in recent years.

Integrity signals

Registry

Crossref · 10.1001/jama.291.22.2720

Cites

33 of 33 references verified0 citation errors · 0 not checkable

Statistics

Recomputing p-values needs the paper’s full text.

Claims the paper makes

This paper’s full text isn’t openly available, so its claims and self-check weren’t run. The registry and citation checks still apply.

Claims other papers make about this one

Each is checked against this paper’s own text: does it say what the citing paper says it does?

Cites

Flagged first, then by citations

Cited by

Sorted by citations

Related

Authors
Murthy, V. H., Krumholz, H. M., & Gross, C. P.
Affiliations
Yale University (US)
ORCID
Venue
JAMA
Publisher
American Medical Association (AMA)
Published
2004-06-09
Volume
291
Issue
22
Pages
2720
ISSN
  • 0002-9955 (ISSN-L)
  • 0098-7484
DOI
10.1001/jama.291.22.2720
OpenAlex
W2074048861
Cited by
2,078
References
33
Citations by year
2026: 56 · 2025: 98 · 2024: 113 · 2023: 147 · 2022: 157 · 2021: 169 · 2020: 142 · 2019: 124 · 2018: 102 · 2017: 94 · 2016: 106 · 2015: 101 · 2014: 115 · 2013: 80 · 2012: 60
FWCI
48.46
Type
journal article
Language
en
Open access
closed
Locations
  • JAMA (publishedVersion)
  • PubMed (publishedVersion)
  • DigitalGeorgetown (Georgetown University Library) (submittedVersion)
Funders
  • National Institute on Aging (P30AG021342)
  • National Cancer Institute (K07CA090402)
Topics
  • Health Sciences › Medicine › Public Health, Environmental and Occupational Health › Ethics in Clinical Research
  • Health Sciences › Medicine › Oncology › Global Cancer Incidence and Screening
  • Physical Sciences › Mathematics › Statistics and Probability › Statistical Methods in Clinical Trials
Keywords
underrepresentation, racial and ethnic minorities, women in clinical trials, elderly patients, cancer clinical trials, breast cancer, colorectal cancer, lung cancer, prostate cancer, Hispanic patients, Black patients, enrollment trends
MeSH terms
Adult, Aged, Clinical Trials as Topic, Cross-Sectional Studies, Female, Health Services Accessibility, Humans, Male, Middle Aged, Minority Groups, National Institutes of Health (U.S.), Neoplasms, United States, Logistic Models, Age Distribution, Sex Distribution, White People

About these checks

Registry, retraction, Cites and statistics results are computed, not judged, with one exception: a printed reference that no index lists is read once by a model before it counts as a citation error. Claims are extracted by a model and kept only when their quote appears verbatim in the text; each cited source is then checked, with a model’s help, for whether it says what the claim relies on. Those verdicts can be wrong — read the claim’s quote and the cited source before relying on one.

Statistics and arithmetic are recomputed, not judged.

Confidence bands are shown only for fields calibrated on our annotated test set. None is calibrated yet, so no band is shown.

What counts as a claim ›How we measure confidence ›How we check this ›

Are you an author, or do you see a problem with this page? Request a review