A comprehensive analysis of patient demographics and disparities in contemporary oncology clinical trials (2022-2023).

Abstract

e13748 Background: Overcoming disparities in cancer research is a major challenge that needs to be prioritized in clinical trials in oncology. In this study, we aimed to assess the current representation of patient demographics in phase 2 and 3 clinical trials in oncology to illuminate healthcare inequities during clinical trial recruitment. Methods: We identified published phase 2 and phase 3 oncology studies in five medical journals (New England Journal of Medicine, Journal of Clinical Oncology, Lancet, Lancet Oncology, and JAMA Oncology). We extracted data on patient demographics including sex, age, race, and ethnicity. We also extracted information on trial sponsorship (industry vs investigator initiated). Results: We included 381 articles published between 2022 and 2023 (108 investigator-initiated; 273 industry-sponsored). Details on age groups (<65 vs >65) were available in 149 studies (n=78,523 patients) including 47,192 (60.1%) < 65; and 31,331 (39.9%) >65. Data on gender were available in 373 studies (n=159,836 patients) including 73,308 (45.9%) males and 86,526 (54.1%) females (2 patients were listed as other). Race was reported in 214 studies (n=92,562) including 65,876 Caucasian (71.2%), 3,428 (3.7%) Black, 18,235 (19.7%) Asian, and 5,023 (5.4%) other/missing. Ethnicity data were available in 52 studies including 2,570 Hispanics (12.4%) and 18,234 non-Hispanics or unknown (87.6%). Conclusions: While there are efforts being made to diversify the recruitment of clinical trials, inequities in trial recruitment remains a major issue. Caucasian and younger patients represented the majority of patients, which may not be reflective of real-world practice. There is an important need to focus on increasing enrollment of underrepresented populations and understanding barriers to enrollment.