Tufts CSDD, Boston, MA, USA.
Ther Innov Regul Sci. 2022 Sep;56(5):795-804. doi: 10.1007/s43441-022-00421-0. Epub 2022 Jun 9.
Following up on a study from 2019, Tufts CSDD collected and analyzed data on demographic disparities and representation in pivotal trials supporting the marketing authorization of novel drugs and biologics approved in Europe between 2007 and 2019.
Data were collected from products' EPAR, the EUDRACT database, and other publicly available sources, and compared to indication-specific demographic data or a census estimate. In total, data were collected on 446 drugs and 943 pivotal trials.
Results indicated that gender demographic data were only reported for 80.7% of pivotal trials, and that racial and ethnicity demographic data were reported less often (64.1% and 29.9% of pivotal trials, respectively). Results also indicated that non-white racial identities were under-represented by more than 20% in nearly half or more of pivotal trials.
Guidelines encouraging the reporting of patient demographic data are insufficient and availability of the data is problematic. The available data suggest that under-representation in pivotal trials is widespread.
在 2019 年的一项研究之后，塔夫茨 CSDD 收集和分析了数据，这些数据涉及在 2007 年至 2019 年间支持在欧洲获得批准的新型药物和生物制品营销许可的关键试验中的人口统计学差异和代表性。
数据来自产品的 EPAR、EUDRACT 数据库和其他公开来源，并与特定适应症的人口统计学数据或人口普查估计进行了比较。总共收集了 446 种药物和 943 项关键试验的数据。
结果表明，只有 80.7%的关键试验报告了性别人口统计学数据，而种族和民族人口统计学数据的报告频率较低（分别为 64.1%和 29.9%的关键试验）。结果还表明，近一半或更多的关键试验中，非白色种族身份的代表性不足 20%。
鼓励报告患者人口统计学数据的指南不足，并且数据的可用性存在问题。现有数据表明，关键试验中的代表性不足是普遍存在的。
