阿尔茨海默病临床试验入选标准对参与者年龄的影响。
Impacts of Eligibility Criteria on Trial Participants' Age in Alzheimer's Disease Clinical Trials.
机构信息
University of Florida, Gainesville, Florida, USA.
Weill Cornell Medicine, New York City, New York, USA.
出版信息
AMIA Annu Symp Proc. 2023 Apr 29;2022:368-376. eCollection 2022.
Overly restricted and poorly designed eligibility criteria reduce the generalizability of the results from clinical trials. We conducted a study to identify and quantify the impacts of study traits extracted from eligibility criteria on the age of study populations in Alzheimer's Disease (AD) clinical trials. Using machine learning methods and SHapley Additive exPlanation (SHAP) values, we identified 30 and 34 study traits that excluded older patients from AD trials in our 2 generated target populations respectively. We also found that study traits had different magnitudes of impacts on the age distributions of the generated study populations across racial-ethnic groups. To our best knowledge, this was the first study that quantified the impact of eligibility criteria on the age of AD trial participants. Our research is a first step in addressing the overly restrictive eligibility criteria in AD clinical trials.
过于严格和设计不佳的入选标准降低了临床试验结果的普遍性。我们进行了一项研究，以确定和量化从入选标准中提取的研究特征对阿尔茨海默病（AD）临床试验中研究人群年龄的影响。使用机器学习方法和 SHapley Additive exPlanation (SHAP) 值，我们在我们生成的两个目标人群中分别确定了 30 个和 34 个研究特征，这些特征将老年患者排除在 AD 试验之外。我们还发现，研究特征对不同种族-民族群体的生成研究人群的年龄分布有不同程度的影响。据我们所知，这是第一项量化入选标准对 AD 试验参与者年龄影响的研究。我们的研究是解决 AD 临床试验中过于严格的入选标准的第一步。
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