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

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.

Breast Cancer Disparities and the COVID-19 Pandemic

“…Furthermore, minority groups, particularly African American women, are overrepresented among more advanced stages of disease that may seek to benefit from results of these clinical trials. A recent review of the clinical trial registry found that between 2009 and 2019, Black and Hispanic patients represented only 2.47% and 2.30%, respectively, of enrollees in clinical trials for oral chemotherapy agents [ 8 ]. Reasons for this are multifactorial but include longstanding mistrust and fear of the healthcare system [ 23 ].…”

“…Increased frequency of pathogenic variants of the BRCA1 and BRCA2 genes has been reported among Black and Hispanic patients, which confers an increased lifetime risk of developing breast cancer [ 6 ]. Importantly, reduced participation in clinical trials by racial and ethnic minorities has hindered scientific progress to design more targeted therapies to account for biological differences in disease [ 7 , 8 ].…”

Cancer patients' experience with a pharmacist‐led oral chemotherapy clinic: A qualitative descriptive study

“…The US Food and Drug Administration (FDA) has approved over 80 oral chemotherapeutics between 2009 and 2019. 1 Oral chemotherapeutics make up approximately 25%-35% of oncology agents that are currently in development. 2 For many patients, infusion chemotherapy can be burdensome due to frequent clinic visits for treatments that can last several hours.…”

“…Over the past 20 years, there has been an increase in the approval and utilization of oral chemotherapy regimens. The US Food and Drug Administration (FDA) has approved over 80 oral chemotherapeutics between 2009 and 2019 1 . Oral chemotherapeutics make up approximately 25%–35% of oncology agents that are currently in development 2…”

The Problem of Hispanic/Latinx Under-Representation in Cancer Clinical Trials

“…8,10,12,[14][15][16][17] Hispanic/Latinx account for only 2.3%-3.9% of therapeutic trial participants, with a trend of decreased participation over time, and about 5% of participants in biorepositories. 14,15,18,19 Under-representation of Hispanic/Latinx in clinical trials compared with their proportion of prevalent cases persists across common cancer types (Fig 1 ), including those in which Hispanic/Latinx have increased risk (ie, liver, gastric, or cervical cancer). 14,20 Similar trends of under-representation are seen in pediatric cancer clinical trials and research.…”