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人口统计数据的比较:国家肌缩侧面硬化病登记和临床试验数据数据

Moon Han¹, Jaime Raymond², Theodore C Larson²

¹Office of Innovation and Analytics, Agency for Toxic Substances and Disease Registry/Centers for Disease Control and Prevention, 4770 Buford Hwy NE, Atlanta, GA, 30341, USA. ptr6@cdc.gov.

Journal of racial and ethnic health disparities

|July 8, 2024

概括

聚合资源开放访问ALS临床试验 (PRO-ACT) 数据库的参与者较年轻,种族多样性较少,与国家肌缩侧面硬化症 (ALS) 注册表相比. 了解这些差异是改善ALS临床试验招募和概括性的关键.

科学领域:

神经科学是一个神经科学.
临床研究临床研究
生物统计学生物统计学

背景情况:

肌缩侧面硬化症 (ALS) 研究依赖于各种患者数据来实现概括性.
像PRO-ACT这样的临床试验数据库和像国家ALS注册表这样的患者注册表对ALS研究至关重要.
描述这些数据来源之间的人口差异对于理解招聘偏见至关重要.

研究的目的:

为了比较PRO-ACT数据库和国家ALS注册表之间的参与者人口统计数据.
确定ALS研究队伍中年龄和种族代表性的潜在差异.
为提高患者参与和ALS临床试验的概括性制定策略.

主要方法:

来自PRO-ACT数据库 (临床试验) 和国家ALS注册表 (自我报告数据) 的人口统计和临床数据进行了比较.
数据涵盖了2010年至2021年的注册表数据,以及到2022年8月的PRO-ACT数据.
关键的人口变量包括年龄,种族和从症状发作到诊断的时间.

主要成果:

与注册表相比,PRO-ACT数据显示年轻参与者的比例较高 (≤59岁),老年参与者的比例较低 (60岁以上).
登记册中少数种族群体的入学率更高,而在PRO-ACT中,种族数据基本上缺失.
登记登记者在诊断和症状发作时的中位数年龄更高,从症状发作到诊断的时间更长.

结论:

在PRO-ACT和注册人口之间,年龄分布和少数民族代表性存在显著差异.
在PRO-ACT数据库中,代表的是一个年轻且不那么多元化的群体.
解决PRO-ACT和注册数据中的代表性不足对于改善患者选择标准和ALS研究结果的概括性至关重要.

关键词:

肌缩性侧面硬化症 (AMLS) 是一种疾病.临床试验中的临床试验.人口统计学人口统计学不平等性不平等性美国国家ALS注册表.在这个过程中,PRO-ACT

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