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探索 2013 年至 2023 年加拿大参与的肺癌临床试验中的人口统计学代表性和报告情况。

Exploring Demographic Representation and Reporting in Lung Cancer Clinical Trials with Canadian Sites from 2013 to 2023.

机构信息

Amgen Canada Inc., 6775 Financial Drive, Suite 300, Mississauga, ON L5N 0A4, Canada.

Faculty of Medicine, University of Ottawa, Roger Guindon Hall, Ottawa, ON K1H 8M5, Canada.

出版信息

Curr Oncol. 2024 Sep 17;31(9):5573-5598. doi: 10.3390/curroncol31090413.

DOI:10.3390/curroncol31090413
PMID:39330041
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC11430770/
Abstract

This review evaluates the reporting of demographic characteristics and the diversity of participants of phase III lung cancer clinical trials with Canadian research sites. A literature search was conducted using the ClinicalTrials.gov registry to identify clinical trials conducted between 1 January 2013, and 31 December 2023. The demographic reporting practices and the representation of sex/gender, racial, and ethnic groups were assessed. The location of Canadian research sites was also examined for trends in reporting and representation. Associated publications were reviewed for demographic data collection methods. Of the 25 clinical trials, 24 reported race and 18 also reported ethnicity. All clinical trials reported sex/gender, and the city and province of the participating Canadian sites. Most participants were White (66.1%), identified as not Hispanic or Latino (81.4%), and were male (57.8%). The provinces with the most clinical trial sites were Ontario (43.6%) and Quebec (34.2%). Lung cancer clinical trials lack adequate demographic reporting and representation of females, diverse patient groups, and geographical locations in Canada with high lung cancer incidence rates. Specifically, the Indigenous Peoples of Canada and Nunavut require better representation in lung cancer clinical trials conducted in Canada. These findings highlight the need to improve diversity and demographic representation in clinical research.

摘要

这篇综述评估了加拿大研究点参与的三期肺癌临床试验中报告人口统计学特征和参与者多样性的情况。使用 ClinicalTrials.gov 注册处进行了文献检索,以确定 2013 年 1 月 1 日至 2023 年 12 月 31 日期间进行的临床试验。评估了人口统计学报告的实践和性别/性别、种族和族裔群体的代表性。还检查了加拿大研究点的位置,以了解报告和代表性方面的趋势。还审查了相关出版物,以了解人口统计学数据收集方法。在 25 项临床试验中,有 24 项报告了种族,18 项也报告了族裔。所有临床试验都报告了性别/性别,以及参与的加拿大站点的城市和省份。大多数参与者是白人(66.1%),不属于西班牙裔或拉丁裔(81.4%),且为男性(57.8%)。临床试验点最多的省份是安大略省(43.6%)和魁北克省(34.2%)。肺癌临床试验在报告女性、不同患者群体和加拿大肺癌发病率较高地区的人口统计学特征方面存在不足。具体来说,加拿大的原住民和努纳武特地区需要在加拿大进行的肺癌临床试验中得到更好的代表。这些发现强调了需要改善临床研究中的多样性和人口统计学代表性。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/e61c/11430770/f849f0a515a5/curroncol-31-00413-g004.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/e61c/11430770/0f3a442ff841/curroncol-31-00413-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/e61c/11430770/57bc08aa2e59/curroncol-31-00413-g002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/e61c/11430770/c3c82d001c67/curroncol-31-00413-g003.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/e61c/11430770/f849f0a515a5/curroncol-31-00413-g004.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/e61c/11430770/0f3a442ff841/curroncol-31-00413-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/e61c/11430770/57bc08aa2e59/curroncol-31-00413-g002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/e61c/11430770/c3c82d001c67/curroncol-31-00413-g003.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/e61c/11430770/f849f0a515a5/curroncol-31-00413-g004.jpg

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本文引用的文献

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KEYNOTE-604研究中患者报告的与健康相关的生活质量:帕博利珠单抗或安慰剂联合依托泊苷和铂类作为广泛期小细胞肺癌的一线治疗
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