Representation of Minorities and Women in Oncology Clinical Trials: Review of the Past 14 Years

Purpose: Many cancer clinical trials lack appropriate representation of specific patient populations, limiting their generalizability. Therefore, we determined the representation of ethnic minorities and women in cancer clinical trials. Methods: Enrollment data from all therapeutic trials reported as completed in ClinicalTrials.gov from 2003 to 2016 were analyzed. We calculated enrollment fractions (EFs) for each group, defined as the number of enrollees divided by the 2013 Surveillance, Epidemiology, and End Results (SEER) database cancer prevalence. Results: Of 1,012 clinical trials, 310 (31%) reported ethnicity with a total of 55,689 enrollees. Participation varied significantly across ethnic groups. Non-Hispanic whites were more likely to be enrolled in clinical trials (EF, 1.2%) than African Americans (EF, 0.7%; P < .001) and Hispanics (EF, 0.4%; P < .001). A decrease in African American (6% v 9.2%) and Hispanic (2.6% v 3.1%) enrollment was observed when compared with historical data from 1996 to 2002. Younger patients (age younger than 65 years) were more likely to be enrolled in clinical trials than the elderly (64% v 36%; P < .001). Low recruitment of female patients was observed in clinical trials for melanoma (35%), lung cancer (39%), and pancreatic cancer (40%). Conclusion: We observed a decrease in recruitment of minorities over the past 14 years compared with historical data. African Americans, Hispanics, and women were less likely to be enrolled in cancer clinical trials. Future trials should take extra measures to recruit participants that adequately represent the US cancer population.

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Representation of minorities in oncology clinical trials: Review of the past 14 years.

Journal of Clinical Oncology ◽

10.1200/jco.2017.35.15_suppl.2533 ◽

2017 ◽

Vol 35 (15_suppl) ◽

pp. 2533-2533

Author(s):

Narjust Duma ◽

Jesus Vera Aguilera ◽

Jonas Paludo ◽

Yucai Wang ◽

Konstantinos Leventakos ◽

...

Keyword(s):

Clinical Trials ◽

African Americans ◽

Historical Data ◽

Molecular Testing ◽

Chi Square ◽

Cancer Prevalence ◽

The Past ◽

Therapeutic Trials ◽

Oncology Clinical Trials ◽

Breast And Prostate Cancer

2533 Background: Many cancer clinical trials (CT) lack appropriate representation of specific patients populations, limiting the generalizability of the evidence obtained. Therefore, we determined the representation of ethnic minorities in oncology CT. Methods: Enrollment data from all therapeutic trials reported as completed in clinicaltrial.gov from 2003 to 2016 were analyzed. CT in rare cancers (< 1% incidence) or with recruitment outside of the US were excluded. Enrollment fraction (EF) was defined as the number of enrollees divided by the 2013 SEER database cancer prevalence. Chi-square test was used to estimate differences in categorical data. Results: Out of 1,012 CT, 310 (31%) reported ethnicity with a total of 55689 enrollees. Distribution by race and comparison with data from 1996-2002, US cancer prevalence and US census are described in the Table. Participation in CT varied significantly across ethnic groups, non-Hispanic Whites (NHW) were more likely to be enrolled in CT (EF of 1.2%) than African Americans (EF of 0.7%, p < 0.001) and Hispanics (EF of 0.4%, p<0.001). A decrease in African Americans (AA) and Hispanics (H) enrollment was observed when compared with historical data from 1996 to 2002. Hispanics were less represented in breast and prostate cancer CT contributing only to 3% and 1.5% of the study population; African Americans were less represented in lung (5.4%) and renal cell carcinoma (3%) trials. Asians were well represented and their recruitment doubled over the past 14 years (2% vs 5.3%). Conclusions: African Americans and Hispanics were less likely to be enrolled in CT. Comparing with historical data; we observed a decrease in minorities’ recruitment in the past 14 years. This change could be attributed to the increased complexity of CT and mandatory molecular testing as many minorities lack access to institutions with genetic testing capacity. Future trials should take extra measures to recruit participants that adequately represent the U.S. cancer population. [Table: see text]

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Enrollment disparities in cancer clinical trials leading to FDA approvals between 2008 and 2020.

Journal of Clinical Oncology ◽

10.1200/jco.2021.39.15_suppl.e18501 ◽

2021 ◽

Vol 39 (15_suppl) ◽

pp. e18501-e18501

Author(s):

Ryan Huu-Tuan Nguyen ◽

Yomaira Silva ◽

Vijayakrishna K. Gadi

Keyword(s):

Prostate Cancer ◽

United States ◽

Clinical Trials ◽

Drug Approval ◽

The United States ◽

Cancer Clinical Trials ◽

Cancer Prevalence ◽

Fda Approval ◽

The Us ◽

Enrollment Data

e18501 Background: Cancer clinical trials based in the United States (US) have lacked adequate representation of racial and ethnic minorities, the elderly, and women. Pivotal clinical trials leading to United States Food and Drug Administration (FDA) approval are often multi-national trials and may also lack generalizability to underrepresented populations in the United States. We determined the racial, ethnic, age, and sex enrollment in pivotal trials relative to the US cancer population. Methods: We reviewed the FDA’s Drug Approvals and Databases for novel and new use drug approvals for breast, colorectal, lung, and prostate cancer indications from 2008 through 2020. Drugs@FDA was searched for drug approval summaries and FDA labels to identify clinical trials used to justify clinical efficacy that led to FDA approval. For eligible trials, enrollment data were obtained from FDA approval summaries, FDA labels, ClinicalTrials.gov, and corresponding journal manuscripts. Enrollment Fraction (EF) was calculated as enrollment in identified clinical trials divided by 2017 SEER cancer prevalence. All data sources were publicly available. Results: From 2008 through 2020, 60 drugs received novel or new use drug approval for breast, colorectal, lung, or prostate cancer indications based on 66 clinical trials with a total enrollment of 36,830. North America accounted for 9,259 (31%) enrollees of the 73% of trials reporting location of enrollment. Racial demographics were reported in 78% of manuscripts, 66% of ClinicalTrials.gov pages, and 98% of FDA labels or approval summaries. Compared with a 0.4% enrollment fraction among White patients, lower enrollment fractions were noted in Hispanic (0.2%, odds ratio [OR] vs White, 0.46; 95% confidence interval [CI], 0.43 to 0.49, P< 0.001) and Black (0.1%, OR 0.29; 95% CI 0.28 to 0.31, P< 0.001) patients. Elderly patients (age ≥ 65 years) were less likely than younger patients to be enrollees (EF 0.3% vs 0.9%, OR 0.27; 95% CI 0.26 to 0.27, P< 0.001) despite accounting for 61.3% of cancer prevalence. For colorectal and lung cancer trials, females were less likely than males (EF 0.7% vs 1.1%, OR 0.66; 95% CI 0.63 to 0.68, P< 0.001) to be enrolled. Conclusions: Black, Hispanic, elderly, and female patients were less likely to enroll in cancer clinical trials leading to FDA approvals from 2008 to 2020. Race and geographic enrollment data were inconsistently reported in journal manuscripts and ClinicalTrials.gov. The lack of appropriate representation of specific patient populations in these key clinical trials limits their generalizability. Future efforts must be made to ensure equitable access, representation, and reporting of enrollees that adequately represent the US population of patients with cancer.

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Shaping the standard of care in ovarian cancer management: A review of Gynecologic Oncology Group (GOG)/NRG oncology clinical trials of the past twenty years

Gynecologic Oncology ◽

10.1016/j.ygyno.2019.02.020 ◽

2019 ◽

Vol 153 (3) ◽

pp. 479-486 ◽

Cited By ~ 1

Author(s):

Paul A. DiSilvestro

Keyword(s):

Ovarian Cancer ◽

Clinical Trials ◽

Gynecologic Oncology ◽

Standard Of Care ◽

Gynecologic Oncology Group ◽

Oncology Group ◽

Cancer Management ◽

The Past ◽

Oncology Clinical Trials

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Recruitment of African Americans to National Oncology Clinical Trials through a Clinical Trial Shared Resource

Journal of Health Care for the Poor and Underserved ◽

10.1353/hpu.0.0251 ◽

2010 ◽

Vol 21 (1A) ◽

pp. 38-50 ◽

Cited By ~ 26

Author(s):

Debra Wujcik ◽

Steven N. Wolff

Keyword(s):

Clinical Trial ◽

Clinical Trials ◽

African Americans ◽

Shared Resource ◽

Oncology Clinical Trials

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Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events: Methods for item selection in industry-sponsored oncology clinical trials

Clinical Trials ◽

10.1177/1740774518799985 ◽

2018 ◽

Vol 15 (6) ◽

pp. 616-623 ◽

Cited By ~ 7

Author(s):

Peter C Trask ◽

Amylou C Dueck ◽

Elisabeth Piault ◽

Alicyn Campbell

Keyword(s):

Clinical Trials ◽

Adverse Events ◽

Patient Reported Outcomes ◽

Selection Process ◽

Late Phase ◽

Relevant Information ◽

Specific Patient ◽

Patient Reported ◽

Oncology Clinical Trials ◽

The Common

As new cancer treatment regimens demonstrate increased potential to improve patients’ survival, more focus is directed toward the quality of that extension of life and to obtaining additional information from patients regarding their experience with treatment. The utility of capturing patient-reported treatment-related symptoms to complement traditional clinician-rated symptomatic adverse event reporting is well-documented. The National Cancer Institute’s Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events is an item library aimed at capturing patient-reported symptoms to inform the patient perspective on a treatment’s tolerability. The U.S. Food and Drug Administration has recommended using the Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events in clinical trials. A practical guideline is needed to inform a priori selection of specific Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events items for use in any given industry-sponsored oncology clinical trial. Standardizing this selection process will foster systematic and consistent data collection as part of drug development and enhance our knowledge on how to use patient-relevant information as part of a treatment’s risk/benefit assessment. This article presents methods and consensus recommendations for selecting specific Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events items to include in early-phase and late-phase oncology clinical trials.

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