Cancer Disparities and Black American Representation in Clinical Trials Leading to the Approval of Oral Chemotherapy Drugs in the United States Between 2009 and 2019.

Veronica B Ajewole,Oyinkansola Akindele,Jazzmin J Marshall,Okwuoma Ndulue,Yhenew T Mossi,Uzoamaka Abajue

doi:10.1200/op.20.01108

Veronica B Ajewole, Oyinkansola Akindele + Show 4 more

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https://doi.org/10.1200/op.20.01108

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Abstract

PURPOSE:Over the past 10 years, oral chemotherapy made up about half (45.6%) of all US Food and Drug Administration (FDA)–approved oncolytic and hematologic medications. Given the disparity in incidence and mortality rate because of certain cancers among Black Americans (BAs) in the United States, a review of BA’s representation in the clinical trials that lead to the development and FDA approval of oral chemotherapy drugs becomes imperative. The objective of this study was to evaluate the reporting of race and inclusion of BA in clinical trials that led to the approval of oral chemotherapy medications by the FDA from 2009 to 2019 in the United States. Additionally, we evaluated the inclusion of BAs in clinical trials of three cancer types with the highest disparity rates among BAs (lung, breast, and prostate).METHODS:A retrospective review of all FDA-approved oral chemotherapy drug from 2009-2019 was obtained using the FDA’s Hematology/Oncology Approvals & Safety Notifications website. Reports of racial and demographics inclusion were obtained from the clinical trials registry.RESULTS:Primary outcome: 142 clinical trials led to FDA approval of 81 oral chemotherapy agents between 2009 and 2019, among which 74 (52%) reported on at least one race and were included in our analysis. 35,933 participants were enrolled in these 74 clinical trials, among which 25,684 (71.47%), 6,061 (16.87%), 889 (2.47%), and 826 (2.30%) were White, Asian, Black, and Hispanic, respectively. BAs were also under-represented in the clinical trials of three cancer types with the highest disparity rates among this population.CONCLUSION:BAs were under-represented in clinical trials leading to FDA approval of oral chemotherapy drugs. There should be more BAs in cancer clinical trials to increase the generalizability of the results, improve outcomes, and eventually close the health disparity gap among this patient population.

Highlights

Oral chemotherapy agents have become more prevalent in treating various cancers
Primary outcome: 142 clinical trials led to Food and Drug Administration (FDA) approval of 81 oral chemotherapy agents between 2009 and 2019, among which 74 (52%) reported on at least one race and were included in our analysis. 35,933 participants were enrolled in these 74 clinical trials, among which 25,684 (71.47%), 6,061 (16.87%), 889 (2.47%), and 826 (2.30%) were White, Asian, Black, and Hispanic, respectively
Black Americans (BAs) were under-represented in clinical trials leading to FDA approval of oral chemotherapy drugs

Summary

Introduction

Oral chemotherapy agents have become more prevalent in treating various cancers. The increased occurrence of oral chemotherapy usage has been attributed to ease of administration and improved quality of life.. Many oral chemotherapy agents have been approved by the FDA, patient populations from diverse racialethnic background inclusive of the US population are often not adequately represented or reported in clinical trials, leading to racial disparity among oncology patient representation in clinical trials.. According to Healthy People 2020, health disparity is a health difference that is intricately linked with social, economic, and/or environmental disadvantage.. According to the National Institutes of Health (NIH), health disparity populations include Black or African American, Hispanic or Latino, American Indian or Alaska Native, Asian American, Native Hawaiian, and other Pacific Islander.. Between March 2009 and December 2019, the US Food and Drug Administration (FDA) approved 81 oral chemotherapy agents with some oral chemotherapy agents having multiple indicatons. The increased occurrence of oral chemotherapy usage has been attributed to ease of administration and improved quality of life. many oral chemotherapy agents have been approved by the FDA, patient populations from diverse racialethnic background inclusive of the US population are often not adequately represented or reported in clinical trials, leading to racial disparity among oncology patient representation in clinical trials. According to Healthy People 2020, health disparity is a health difference that is intricately linked with social, economic, and/or environmental disadvantage. Racial disparities in health care can have a significant impact on patient outcomes and survival. According to the National Institutes of Health (NIH), health disparity populations include Black or African American, Hispanic or Latino, American Indian or Alaska Native, Asian American, Native Hawaiian, and other Pacific Islander. Ethnic minorities, Black Americans (BAs), have higher incidence for many cancers such as lung, prostate, and colon, which occur in 62.4, 173.0, and 45.7 BAs per 100,000 people, compared with 63.5, 97.1, and 38.6 White per 100,000 people, respectively. BAs

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