Clinical trials were vital tools to prove the effectiveness and safety of medications. To maximize generalizability, the study sample should represent the sample population and the target population. However, the clinical trial design tends to favor the evaluation of drug safety and procedure (i.e., internal validity) without clear knowledge of its penalty on trial generalizability (i.e., external validity). Alzheimer's Disease (AD) trials are known to have generalizability issues. Thus, in this study, we explore the effect of eligibility criteria on the AD severity patients and the severe adverse event (SAE) among the eligible patients.
Keywords: SHAP value; clinical trial; eligibility criteria; machine learning.