美国肺癌临床试验参与度不均。
Disparities in US Lung Cancer Clinical Trial Enrollment.
发表日期:2023 Aug 31
作者:
Seyda Kilic, Jenny Zhao, Hayrettin Okut, Chinmay T Jani, Amr Radwan, Harshitha Dudipala, Laura Burns, Umit Tapan
来源:
Burns & Trauma
摘要:
临床试验招募中的不平等已有详尽的记录,降低了结果的普遍适用性。尽管自国会通过了NIH复兴法案以鼓励少数种族人群参与临床试验已过去近30年,但这些患者仍然被低估。本研究旨在调查肺癌临床试验中种族/民族、性别和年龄的招募差距。我们查询了美国国家医学图书馆的美国国立卫生研究院数据库中2004年至2021年间完成的所有基于美国的肺癌临床试验,并收集了有关种族和民族、性别和年龄的数据。将这些数据与“Surveillance, Epidemiology, and End Results(SEER)”数据库的数据进行比较。独立样本t检验和Kruskal-Wallis方法被用于分析数据。在311个符合条件且仅限于美国的招募试验中,有136个(44%)报告了代表9869名患者的种族和民族构成情况。西班牙裔、非西班牙裔美洲印第安/阿拉斯加原住民、非西班牙裔黑人和未报道的非西班牙裔参与者被低估(p = 0.001,p = 0.005,p = 0.014,p = 0.002)。非西班牙裔白人参与者被高估(p = 0.018)。从2017年至2021年,西班牙裔患者的差距恶化(p = 0.03)。性别和年龄方面没有显著差异。自2004年以来,肺癌临床试验招募的不平等没有得到显著的改善,代表性仍然不平等,尤其是对于种族和民族少数群体而言。
© 2023. W. Montague Cobb-NMA卫生研究所。
Disparities within clinical trial enrollment are well-documented, reducing the generalizability of results. Although nearly 30 years have passed since Congress passed the NIH Revitalization Act to encourage the participation of minoritized populations in clinical trials, these patients continue to be underrepresented. This study aimed to investigate lung cancer clinical trial enrollment disparities for race/ethnicity, sex, and age.We queried the National Institutes of Health: US National Library of Medicine database of clinical trials for all US-based lung cancer clinical trials completed between 2004 and 2021 and collected data on race and ethnicity, gender, and age breakdown. This data was compared to Surveillance, Epidemiology, and End Results (SEER) database data. Independent sample t-tests and Kruskal-Wallis's approach were used to analyze the data.Of 311 eligible trials with exclusive US enrollment, 136 (44%) reported race and ethnicity breakdown for the patient cohort representing 9869 patients. Hispanic, Non-Hispanic American Indian/Alaska Native, Non-Hispanic Black, and Non-Hispanic Unreported participants were underrepresented (p = 0.001, p = 0.005, p = 0.014, p = 0.002, respectively). Non-Hispanic White participants were overrepresented (p = 0.018). Disparities worsened from 2017 to 2021 for Hispanic patients (p = 0.03). No significant differences were found for sex or age.Disparities for clinical lung cancer trial enrollment have not shown statistically significant improvement since 2004, and representation remains unequal, especially for racial and ethnic minorities.© 2023. W. Montague Cobb-NMA Health Institute.