Disparities in participation in cancer clinical trials in the United States

Cancer ◽  
2008 ◽  
Vol 112 (3) ◽  
pp. 447-454 ◽  
Author(s):  
Gerardo Colon-Otero ◽  
Robert C. Smallridge ◽  
Lawrence A. Solberg ◽  
Thomas D. Keith ◽  
Timothy A. Woodward ◽  
...  
Keyword(s):  
United States ◽  
Clinical Trials ◽  
The United States ◽  
Cancer Clinical Trials

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

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.

Summary of the proceedings of the United States-Japan lung cancer clinical trials summit

1997 ◽  
Vol 123 (8) ◽  
pp. 461-466
Author(s):  
Robert B. Livingston ◽  
Ryosuke Tsuchiya ◽  
Masanori Fukushima ◽  
Charles A. Coltman Jr.
Keyword(s):  
United States ◽  
Lung Cancer ◽  
Clinical Trials ◽  
The United States ◽  
Cancer Clinical Trials

scholarly journals The Underrepresentation of Minorities and Non-Generalizability of Breast Cancer Clinical Trials?

2021 ◽  
Author(s):  
Joseph Angel De Soto
Keyword(s):  
Breast Cancer ◽  
United States ◽  
Clinical Trials ◽  
African Americans ◽  
Native Americans ◽  
Ethnic Minorities ◽  
Minority Groups ◽  
The United States ◽  
Cancer Clinical Trials ◽  
High Death

Introduction This year 43,000 women will die from breast cancer in the United States. African Americans and Native Americans though less likely to get breast cancer, once diagnosed they are much more likely to die from breast cancer. This increased death rate may in part be due to the non-generalizability of breast cancer clinical trials. In this study, we evaluate the participation of ethnic minorities from breast cancer clinical trials. Methodology In this study, fifty-six breast cancer clinical trials completed in the last ten years in the United States were evaluated for the inclusion of ethnic minorities in the breast cancer clinical trials. Results Only 21% of breast cancer clinical trials include information on ethnicity in the methodology while only 7% provided any information on the effect or toxicity of the therapeutic intervention in minority groups while 100% report the results for Whites. Though Whites only make up 60.1% of the population, they were 87.5% of the clinical trial participants while African Americans were 6.2%, Hispanics 3.1%, Asians 2.9% and Native Americans were 0.2% of the participants. Conclusion Racial minorities have been underrepresented in breast cancer clinical trials which may contribute to unnecessarily high death rates in these groups while suggesting limited generalizability of breast cancer clinical trials.

The landscape of precision medicine cancer clinical trials in the United States.

2014 ◽  
Vol 32 (15_suppl) ◽  
pp. 1547-1547
Author(s):  
Nitin Roper ◽  
Kristian Stensland ◽  
Ryan Hendricks ◽  
Matt D. Galsky
Keyword(s):  
United States ◽  
Clinical Trials ◽  
Precision Medicine ◽  
The United States ◽  
Cancer Clinical Trials

scholarly journals Meeting the Challenge: The National Cancer Institute’s Central Institutional Review Board for Multi-Site Research

2018 ◽  
Vol 36 (8) ◽  
pp. 819-824 ◽  
Author(s):  
Holly A. Massett ◽  
Sharon L. Hampp ◽  
Jacquelyn L. Goldberg ◽  
Margaret Mooney ◽  
Linda K. Parreco ◽  
...  
Keyword(s):  
United States ◽  
Clinical Trials ◽  
The United States ◽  
National Institutes Of Health ◽  
Institutional Review Board ◽  
Cancer Clinical Trials ◽  
Limited Data ◽  
Human Patient ◽  
Institutional Review ◽  
Central Institutional Review Board

The National Institutes of Health (NIH) issued a new policy that requires a single institutional review board (IRB) of record be used for all protocols funded by the NIH that are carried out at more than one site in the United States, effective January 2018. This policy affects several hundred clinical trials opened annually across the NIH. Limited data exist to compare the use of a single IRB to that of multiple local IRBs, so some institutions are resistant to or distrustful of single IRBs. Since 2001, the National Cancer Institute (NCI) has funded a central IRB (CIRB) that provides human patient reviews for its extensive national cancer clinical trials program. This paper presents data to show the adoption, efficiencies gained, and satisfaction of the CIRB among NCI trial networks and reviews key lessons gleaned from 16 years of experience that may be informative for others charged with implementation of the new NIH single-IRB policy.

Summary of the Proceedings of the United States-Japan Lung Cancer Clinical Trials Summit

1997 ◽  
Vol 123 (8) ◽  
pp. 461-466 ◽  
Author(s):  
Robert B. Livingston ◽  
Ryosuke Tsuchiva ◽  
Masanori Fukushima ◽  
Charles A. Coltman
Keyword(s):  
United States ◽  
Lung Cancer ◽  
Clinical Trials ◽  
The United States ◽  
Cancer Clinical Trials

scholarly journals Colon Cancer: The Exclusion of Native Americans and Hispanics from Clinical Trials in the United States

2021 ◽  
Author(s):  
Joseph Angel De Soto
Keyword(s):  
United States ◽  
Clinical Trial ◽  
Colon Cancer ◽  
Clinical Trials ◽  
African Americans ◽  
Native Americans ◽  
The United States ◽  
Cancer Clinical Trial ◽  
Cancer Clinical Trials ◽  
Trial Participants

Abstract:Introduction: Each year there are 150,000 new cases of colon cancer in the United States. The chance of death for Hispanics and Native Americans who get colon cancer is much higher than whites even though both groups are much less likely to get colon cancer than whites. In this study, we look at the inclusion or exclusion of Hispanics and Native Americans from colon cancer clinical trials. Methods: In this retrospective study, 48 colon cancer clinical trials in the United States with an aggregate of 421,530 participants performed within the last ten years were selected at random. These clinical trials were evaluated for the inclusion and exclusion of minorities. Results: Though whites make up only 60.1% of the population they make up 89% of the colon cancer clinical trial participants. African Americans, and Hispanics who make up 13.4% and 18.5% of the population only made up 5.6% and 0.6% of the colon cancer clinical trial participants. Only two native Americans out of 421,530 colon cancer clinical trial participants could be identified. Conclusion: Colon Cancer Clinical trials have systematically excluded Hispanics and Native Americans while minimizing the participation of African Americans. This may be directly related to the increased death rates seen in these groups and provides evidence for the non-generalizability of colon cancer clinical trials.

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