Underrepresentation of Asian Americans, Native Hawaiians, and other Pacific Islanders (AA & NHPI) in cancer clinical trials that led to FDA approvals in 2010-2022.

Abstract

11026 Background: About 6% and 0.3% of the total United States (US) population identify as Asian or NHPI alone, respectively. The most commonly diagnosed cancers among AA & NHPI in the US are breast, prostate, lung, thyroid, and colorectal. Liver, gastric, and head and neck cancers occur in higher rates in AA & NHPI vs. non-Hispanic White. Enrollment of Asian & NHPI patients in multiregional cancer clinical trials may provide additional data regarding intrinsic and extrinsic factors (e.g., diet, infections, environmental exposures) impacting the etiology of cancer. We investigated enrollment trends of NHPI and Asian (within and outside of US) patients in cancer clinical trials that led to an FDA approval from 2010-2022. Methods: We analyzed data from ~98,000 patients in 171 cancer therapeutic clinical trials that led to FDA approvals for breast, prostate, lung, thyroid, colorectal, liver, gastric, and head and neck cancer indications from 2010-2022. Separate race categories of Asian and Native Hawaiian and other Pacific Islander were used. Results: Descriptive statistics of NHPI and Asians within and outside of US enrollment in breast, prostate, lung, thyroid, colorectal, liver, gastric, and head and neck cancer trials that led to an FDA approval from 2010-2022 are summarized in the table. Enrollment of Asian patients in the US was <1% (except for liver cancer) and NHPI patients was <0.2%. Conclusions: Although cancer is the leading cause of death for AA & NHPI, AA & NHPI are under-represented in cancer clinical trials, especially when data are further disaggregated into enrollment of NHPI and Asians within and outside of the US. Cancer etiology may vary in Asians in the US vs. Asia due to different intrinsic/extrinsic risk factors, underscoring the importance of enrolling more AA & NHPI into clinical trials to expand the evidence supporting drug approvals in the US and to advance health equity through clinical trial diversity. [Table: see text]