Department of Neurosurgery, Department of Neurology, University of Rochester Medical Center, NY 14618, United States.
CNS Oncol. 2020 Jun;9(2):CNS59. doi: 10.2217/cns-2020-0008. Epub 2020 Jun 30.
To determine if enrollment on glioblastoma (GBM) interventional clinical trials (ICTs) in the USA is representative of the population. We queried ClinicalTrials.gov for all ICTs in GBM from 1994 to 2019. Demographics were obtained from ClinicalTrials.gov or the trial publication and compared with population data from Central Brain Tumor Registry of the United States. In total, 10617 GBM patients were enrolled in 118 adult ICTs: median age was 54.0 (10.05 years younger than Central Brain Tumor Registry of the United States). Age was most discrepant in recurrent tumors, nonrandomized trials and consortium studies. Median age improved from 52.0 to 59.5 over 25 years. Women represented 37.5% of subjects. GBM ICTs under-represent older patients but representation of women reflects the population. ICTs need to be designed to better represent the population.
为了确定美国胶质母细胞瘤（GBM）介入临床试验（ICTs）的入组情况是否能代表该人群。我们在 ClinicalTrials.gov 上检索了 1994 年至 2019 年期间所有的 GBM ICTs。从 ClinicalTrials.gov 或试验出版物中获取了人口统计学数据，并与美国中央脑肿瘤登记处的数据进行了比较。共有 10617 名 GBM 患者入组了 118 项成人 ICTs：中位年龄为 54.0 岁（比美国中央脑肿瘤登记处年轻 10.05 岁）。年龄在复发性肿瘤、非随机试验和联合体研究中差异最大。25 年来，中位年龄从 52.0 岁提高到 59.5 岁。女性占受试者的 37.5%。GBM ICTs 中老年人患者的代表性不足，但女性的代表性反映了人群的情况。ICTs 需要进行设计，以更好地代表人群。
