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临床试验中的多样性增加:2005 年至 2020 年美国国家癌症研究所的人口趋势。

Increasing diversity in clinical trials: demographic trends at the National Cancer Institute, 2005-2020.

机构信息

Medical Oncology Service, Center for Cancer Research, National Cancer Institute, National Institutes of Health, Bethesda, MD, USA.

Genitourinary Malignancies Branch, Center for Cancer Research, National Cancer Institute, National Institutes of Health, Bethesda, MD, USA.

出版信息

J Natl Cancer Inst. 2024 Jul 1;116(7):1063-1071. doi: 10.1093/jnci/djae018.

Abstract

BACKGROUND

We described participant demographics for National Cancer Institute (NCI) clinical trials at the clinical center (NCI-CC participants) of the National Institutes of Health to identify enrollment disparities.

METHODS

We analyzed NCI-CC data from 2005 to 2020, calculated enrollment fractions, compared with the US cancer population represented by the Surveillance, Epidemiology, and End Results cancer incidence data (2018) and the Cancer in North America database (2018), and compared further with clinical trial disparities data from the NCI Community Oncology Research Program and National Clinical Trials Network (2005-2019), and from ClinicalTrials.gov (2003-2016).

RESULTS

NCI-CC (38 531 participants) had higher enrollment fractions for older adults (8.5%), male (5.6%), non-Hispanic (5.1%), and Black or African American (5.3%) participants; lower women proportion across race and ethnicity; and fewer female sex-specific cancer (6.8%) than male sex-specific cancer (11.7%) participants. NCI-CC had lower median age than Surveillance, Epidemiology, and End Results (54.0 vs 65.4); more Black or African American participants (12.0% vs 11.1%); and fewer women (41.7% vs 49.5%), White (76.1% vs 80.5%), Asian or Pacific Islander (4.6% vs 6.0%), American Indian or Alaska Native (0.3% vs 0.5%), and Hispanic participants (7.1% vs 13%). NCI-CC had more Black or African American and Asian or Pacific Islander participants; fewer Hispanic participants than the NCI Community Oncology Research Program and National Clinical Trials Network; more Black or African American and Hispanic participants; fewer Asian or Pacific Islander participants than ClinicalTrials.gov data. Improvement was noted for NCI-CC (older adults, Black or African American, Asian or Pacific Islander, Hispanic participants).

CONCLUSION

We found lower representation of older adults, women, Asian or Pacific Islander, American Indian or Alaska Native, and Hispanic participants vs the US cancer population and higher representation of Black or African American vs US cancer population and oncology clinical trials. Multifaceted efforts are underway to reduce disparities in cancer clinical trials at the NCI-CC.

摘要

背景

我们描述了美国国立卫生研究院(NIH)临床中心(NCI-CC)参与美国国立癌症研究所(NCI)临床试验的参与者人口统计学特征,以确定参与率的差异。

方法

我们分析了 2005 年至 2020 年 NCI-CC 的数据,计算了参与率,将其与美国癌症发病率监测、流行病学和结果数据(2018 年)和北美癌症数据库(2018 年)所代表的美国癌症人群进行了比较,并与 NCI 社区肿瘤学研究计划和国家临床试验网络(2005-2019 年)以及 ClinicalTrials.gov(2003-2016 年)的临床试验差异数据进行了进一步比较。

结果

NCI-CC(38531 名参与者)中老年人(8.5%)、男性(5.6%)、非西班牙裔(5.1%)和非裔美国人(5.3%)的参与率较高;不同种族和族裔的女性比例较低;女性特定癌症(6.8%)的参与者少于男性特定癌症(11.7%)。NCI-CC 的中位年龄低于监测、流行病学和结果(54.0 岁对 65.4 岁);黑人或非裔美国人参与者较多(12.0%对 11.1%);女性(41.7%对 49.5%)、白人(76.1%对 80.5%)、亚洲或太平洋岛民(4.6%对 6.0%)、美洲印第安人或阿拉斯加原住民(0.3%对 0.5%)和西班牙裔参与者(7.1%对 13%)较少。NCI-CC 黑人或非裔美国人和亚洲或太平洋岛民参与者较多;NCI 社区肿瘤学研究计划和国家临床试验网络的西班牙裔参与者较少;黑人或非裔美国人和西班牙裔参与者较多;ClinicalTrials.gov 数据的亚洲或太平洋岛民参与者较少。NCI-CC 老年、黑人或非裔美国人、亚洲或太平洋岛民、西班牙裔参与者的情况有所改善。

结论

我们发现,与美国癌症人群相比,NCI-CC 的老年、女性、亚洲或太平洋岛民、美洲印第安人或阿拉斯加原住民和西班牙裔参与者比例较低,而黑人或非裔美国人比例较高;与美国癌症人群和肿瘤学临床试验相比,黑人或非裔美国人比例较高。目前正在开展多方面的努力,以减少 NCI-CC 癌症临床试验中的差异。

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