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Cited by 570Ethics in Clinical ResearchRace, Genetics, and SocietyStatistical Methods in Clinical Trials

Disparity of Race Reporting and Representation in Clinical Trials Leading to Cancer Drug Approvals From 2008 to 2018

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Loree, Jonathan M., Anand, Seerat, Dasari, Arvind, Unger, Joseph M., Gothwal, Anirudh, Ellis, Lee M., Varadhachary, Gauri, Kopetz, Scott +2 more·2019·JAMA Oncology
DOI 10.1001/jamaoncol.2019.1870PMC PMC6696743
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Abstract

IMPORTANCE: Representative racial/ethnic participation in research, especially in clinical trials that establish standards of care, is necessary to minimize disparities in outcomes and to uphold societal equity in health care. OBJECTIVE: To evaluate the frequency of race reporting and proportional race representation in trials supporting US Food and Drug Administration (FDA) oncology drug approvals. DESIGN, SETTING, AND PARTICIPANTS: Database study of all reported trials supporting FDA oncology drug approvals granted between July 2008 and June 2018. Primary reports of trials were obtained from PubMed and ClinicalTrials.gov. Food and Drug Administration approvals were identified using the FDA archives. The US population-based cancer estimates by race were calculated using National Cancer Institute-Surveillance, Epidemiology, and End Results and US Census databases. MAIN OUTCOMES AND MEASURES: Primary outcomes were the proportion of trials reporting race and the proportion of patients by race participating in trials. Secondary outcomes included race subgroup analyses reporting and gaps between race proportion in trials and the US population. Descriptive statistics, Fisher exact, and χ2 tests were used to analyze the data. Proportions and odds ratios (OR) with 95% CIs were reported. RESULTS: Among 230 trials with a total of 112 293 participants, 145 (63.0%) reported on at least 1 race, 18 (7.8%) documented the 4 major races in the United States (white, Asian, black, and Hispanic), and 58 (25.2%) reported race subgroup analyses. Reporting on white, Asian, black, and Hispanic races was included in 144 (62.6%), 110 (47.8%), 88 (38.2%), and 23 (10.0%) trials, respectively. Between July 2008 and June 2013 vs July 2013 and June 2018, the number of trials reporting race (45 [56.6%] vs 100 [67.1%]; OR, 1.63; 95% CI, 0.93-2.87; P = .09) and race subgroup analysis (13 [16.1%] vs 45 [30.2%]; OR, 2.26, 95% CI, 1.16-4.67; P = .03) changed minimally and varied across races. Whites, Asians, blacks, and Hispanics represented 76.3%, 18.3%, 3.1% and 6.1% of trial participants, respectively, and the proportion for each race enrolled over time changed nominally (blacks, 3.6% vs 2.9% and Hispanics, 5.3% vs 6.7%) from July 2008 to June 2013 vs July 2013 to June 2018. Compared with their proportion of US cancer incidence, blacks (22% of expected) and Hispanics (44% of expected) were underrepresented compared with whites (98% of expected) and Asians (438% of expected). CONCLUSIONS AND RELEVANCE: Race and race subgroup analysis reporting occurs infrequently, and black and Hispanic races are consistently underrepresented compared with their burden of cancer incidence in landmark trials that led to FDA oncology drug approvals. Enhanced minority engagement is needed in trials to ensure the validity of results and reliable benefits to all.

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  • Geographic, sociocultural and economic disparities in access to enrollment have led to a remarkable underrepresentation of several groups in clinical trials.

    “In addition, geographic, sociocultural and economic disparities in access to enrollment, have led to a remarkable underrepresentation of several groups in these studies.”

    From Multimodal biomedical AI (2022) · cites this paper as [32]

    The Discussion reports substantial underrepresentation of Black and Hispanic patients and describes distance, transportation, income, and distrust as barriers to participation. It says socioeconomic status may explain part of the disparity and that the reasons are complex; it does not establish that these factors caused the underrepresentation as the claim states. (LLM, conf=0.84)

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  • Among those cancer therapy trials, only 3.1% of participants identified as Black and 6.1% as Hispanic.

    “Among these, only 3.1 and 6.1% of trial participants identified as Black and Hispanic, respectively.”

    From Enablers and barriers of clinical trial participation in adult patients from minority ethnic groups: a systematic review (2025) · cites this paper as [18]

  • In the US, of cancer therapies approved by the FDA between 2008 and 2018, only 63% of the relevant trials reported race-related data.

    “A 2019 review revealed that of the cancer therapies approved by the US Food and Drug Administration (FDA) between 2008 and 2018, only 63% of the relevant trials reported race-related data [18].”

    From Enablers and barriers of clinical trial participation in adult patients from minority ethnic groups: a systematic review (2025) · cites this paper as [18]

  • This underrepresentation limits the generalizability of results and leads to a scenario whereby widespread underrepresentation in biomedical research further perpetuates existing disparities.

    “This limits the generalizability of results and leads to a scenario whereby widespread underrepresentation in biomedical research further perpetuates existing disparities 32 .”

    From Multimodal biomedical AI (2022) · cites this paper as [32]

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Authors
Loree, J. M., Anand, S., Dasari, A., Unger, J. M., Gothwal, A., Ellis, L. M., Varadhachary, G., Kopetz, S., Overman, M. J., & Raghav, K.
Affiliations
  • BC Cancer Agency (CA)
  • The University of Texas MD Anderson Cancer Center (US)
  • Fred Hutch Cancer Center (US)
  • Baylor University (US)
Corresponding author
Raghav, Kanwal
ORCID
Venue
JAMA Oncology
Publisher
American Medical Association (AMA)
Published
2019-10-10
Volume
5
Issue
10
Pages
e191870
ISSN
2374-2437 (ISSN-L)
DOI
10.1001/jamaoncol.2019.1870
PMC
PMC6696743
OpenAlex
W2969031691
Semantic Scholar
7ef4c8e3b560e1041587d5370115a6db62f37be5
Cited by
570
References
30
Citations by year
2026: 59 · 2025: 67 · 2024: 89 · 2023: 104 · 2022: 120 · 2021: 99 · 2020: 31
FWCI
57.56
Type
journal article
Language
en
Open access
Locations
  • JAMA Oncology (publishedVersion)
  • PubMed Central (publishedVersion)
  • PubMed (publishedVersion)
Funders
National Cancer Institute (UG1CA189974, P30CA016672)
Topics
  • Health Sciences › Medicine › Public Health, Environmental and Occupational Health › Ethics in Clinical Research
  • Life Sciences › Biochemistry, Genetics and Molecular Biology › Genetics › Race, Genetics, and Society
  • Physical Sciences › Mathematics › Statistics and Probability › Statistical Methods in Clinical Trials
Keywords
racial disparities, oncology drug approval, FDA drug approval, cancer clinical trials, health equity, racial disparities in cancer outcomes, racial disparities in cancer survival, racial disparities in cancer incidence, racial disparities in cancer mortality

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